Angina Pectoris, Coronary Artery Disease, Ischemic Heart Disease, Myocardial Ischemia
Conditions
Keywords
Drug Eluting Stent, Coronary Stent, Everolimus, Stent Thrombosis
Brief summary
The objective of the study is to evaluate the safety and efficacy of XIENCE Xpedition Everolimus-Eluting 2.25mm Stent in real world practice in Japanese hospitals.
Detailed description
Based on Good Post-marketing Study Practice (GPSP) regulation, general patient population with ischemic heart disease who are eligible for treatment with XIENCE Xpedition Everolimus-Eluting 2.25mm Stent will be registered, with no particular inclusion/exclusion criteria, and may be eligible for angiographic follow-up at eight months and clinical follow-up at one year. The XIENCE Xpedition 2.25 mm stent is composed of the stent identical to the stent of the XIENCE PRIME SV Stent.Therefore, the data collected from the PMS will be pooled with data collected from the ongoing XIENCE PRIME SV PMS for analysis.
Interventions
DEVICEXIENCE Xpedition 2.25 mm stent
Patients receiving XIENCE Xpedition 2.25 mm stent
Sponsors
Abbott Medical Devices
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Inclusion criteria 1. Patient informed consent is required for registration of this PMS. In cases where patient informed consent (or providing some type of information) is required for PMS per the participating site policy, the Sponsor will cooperate as needed. 2. Patients who are treated by XIENCE Xpedition 2.25mm stent will be registered. * The observations will be compiled on a per-patient basis even if multiple XIENCE Xpedition 2.25mm stents are implanted during the index procedure. * A patient whose side-branch is treated by XIENCE Xpedition 2.25mm stent can be registered. In such a case, main vessel should be treated by XIENCE Xpedition. * The observations will not be compiled on a per-patient basis if a patient is treated by XIENCE Xpedition 2.25mm stent overlapped with other stents for bail-out purpose. * Additional revascularization procedures as a part of adverse event treatment and planned staged procedures will not be considered as another registration, or adverse events. * A patient who is treated, but failed to be implanted by XIENCE Xpedition 2.25mm stent and finally treated by other devices only (No XIENCE Xpedition 2.25mm stent are implanted) must also be registered. In such a case, only the stent information, device deficiency information and reportable adverse events related to the Xpedition stent, if any, are required to be captured. Follow-up of the patient who does not receive any XIENCE Xpedition 2.25mm stent is not required. 2.
Exclusion criteria
1. If it is known at the time of index procedure that the patient is not able to return for the 8-month follow-up visit for angiogram and for the 1-year clinical follow-up, then the patient should not be registered in the PMS. 2. Patients who are attending or will attend other PMS with invasive medical procedure will not be registered. 3. A patient may have another lesion(s) that may be treated by larger diameter (≥ 2.5mm) stent(s). In such a case, treatment by XIENCE Xpedition is preferable. Lesion(s) treated by other than XIENCE Xpedition 2.25mm stent is not considered as the target lesion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Stent Thrombosis: Late | 30 days to 1 year post stent implantation-Day 212 | Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: \>24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: \>1 year post stent implantation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Using Antiplatelet Therapy | At baseline before procedure | Number of patients using aspirin, clopidogrel, ticlopidine, cilostazol,prasugrel, compounding agents and other agents. |
| Number of Participants With Death | During hospitalization | All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. * Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. * Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. * Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. |
| Number of Participants With Target Lesion Revascularization Based on Ischemia Findings | During hospitalization | Target lesion revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. |
| Number of Participants With Myocardial Infarction | During hospitalization | Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. |
| Number of Participants With Cardiac Death | During hospitalization | Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.) |
| Number of Participants With MI Related to Target Vessel | During hospitalization | Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves |
| Number of Participants With Death,Myocardial Infarction and Revascularization (DMR) | During hospitalization | DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization. |
| Number of Participants With All Revascularization | During hospitalization | All revascularization endpoint is comprised of TLR, TVR excluding TLR, and non-TVR. |
| Number of Participants With Target Vessel Failure (TVF) | During hospitalization | Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR). |
| Number of Participants With Target Vessel Revascularization (Non-TLR) | During hospitalization | Target vessel revascularization (TVR) includes ischemia driven TVR, non-TLR and non- ischemia driven TVR, non-TLR. |
| Number of Participants With Target Vessel Revascularization (TLR or TVR (Non-TLR)) | During hospitalization | Target vessel revascularization (TLR or TVR, non-TLR) includes ischemia driven TVR (TLR or TVR, non-TLR) or non-ischemia driven TVR (TLR or TVR, nonTLR). |
| Percent Diameter Stenosis (%DS) | Pre-procedure | In-segment, In-stent, Proximal and Distal. The value calculated as 100 \* (1 - minimum lumen diameter/reference vessel diameter) (MLD/RVD) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA). |
| Number of Participants With Death/All MI | During hospitalization | All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI |
| Number of Participants With Cardiac Death/All MI | During hospitalization | All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI |
| Number of Participants With Cardiac Death or Target-Vessel MI | During hospitalization | Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery). |
| Number of Participants With Target Lesion Failure (TLF) | During hospitalization | TLF is defined as composite of Cardiac Death, Myocardial Infarction (per protocol-defined MI definition), attributable to Target Vessel (TV-MI), or Ischemic-Driven Target Lesion Revascularization (ID-TLR). |
| Mean Acute Gain: In-stent, In-segment | At 8 months, post index procedure | The difference between post- and pre-procedural MLD. |
| Mean Late Loss(LL): In-stent, In-segment, Proximal, and Distal | At 8 months, post index procedure | Late loss is calculated as MLD post procedure - MLD at follow-up. |
| Mean Net Gain: In-stent, In-segment | At 8 months, post index procedure | Late procedural outcome is influenced by both the acute gain provided by the intervention (pre to post) and the subsequent late loss that occurs after the intervention (post to follow-up).The net gain is thus the sum of the offsetting effects of acute gain and late loss (net gain = acute gain - late loss). |
| Mean Lesion Length | Pre-procedure | The lesion length will be measured by QCA. |
| Minimum Blood Vessel Diameter | Pre-procedure | Minimum blood vessel diameter measured by QCA |
| Mean Reference Vessel Diameter (RVD) | Pre-procedure | Reference vessel diameter measured by QCA |
| Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Events-MACE) | During hospitalization | Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR). |
Countries
Japan
Participant flow
Recruitment details
A total of 100 subjects were enrolled from multiple sites.
Participants by arm
| Arm | Count |
|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm Patients receiving XIENCE Xpedition 2.25 mm stent | 100 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Changing hospital | 2 |
| Overall Study | Death | 9 |
| Overall Study | Lost to Follow-up | 11 |
Baseline characteristics
| Characteristic | XIENCE Xpedition 2.25 mm Stent Arm |
|---|---|
| Age, Continuous | 68.2 years STANDARD_DEVIATION 10.3 |
| BMI | 24.23 kg/m^2 STANDARD_DEVIATION 2.82 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 100 Participants |
| Height | 162.58 cm STANDARD_DEVIATION 8.31 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 100 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment Japan | 100 participants |
| Sex: Female, Male Female | 19 Participants |
| Sex: Female, Male Male | 81 Participants |
| Weight | 64.22 kg STANDARD_DEVIATION 10.05 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 9 / 100 |
| other Total, other adverse events | 67 / 100 |
| serious Total, serious adverse events | 63 / 100 |
Outcome results
Primary
Number of Participants With Stent Thrombosis: Late
Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: \>24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: \>1 year post stent implantation
Time frame: 30 days to 1 year post stent implantation-Day 212
Population: Intend To Treat population(ITT population)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants With Stent Thrombosis: Late | 1 Participants |
Secondary
Mean Acute Gain: In-stent, In-segment
The difference between post- and pre-procedural MLD.
Time frame: At 8 months, post index procedure
Population: ITT population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Mean Acute Gain: In-stent, In-segment | Stent | 1.51 mm | Standard Deviation 0.46 |
| XIENCE Xpedition 2.25 mm Stent Arm | Mean Acute Gain: In-stent, In-segment | Segment | 1.20 mm | Standard Deviation 0.5 |
Secondary
Mean Late Loss(LL): In-stent, In-segment, Proximal, and Distal
Late loss is calculated as MLD post procedure - MLD at follow-up.
Time frame: At 8 months, post index procedure
Population: ITT population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Mean Late Loss(LL): In-stent, In-segment, Proximal, and Distal | Stent | 0.28 mm | Standard Deviation 0.36 |
| XIENCE Xpedition 2.25 mm Stent Arm | Mean Late Loss(LL): In-stent, In-segment, Proximal, and Distal | Proximal | 0.03 mm | Standard Deviation 0.36 |
| XIENCE Xpedition 2.25 mm Stent Arm | Mean Late Loss(LL): In-stent, In-segment, Proximal, and Distal | Distal | -0.06 mm | Standard Deviation 0.28 |
| XIENCE Xpedition 2.25 mm Stent Arm | Mean Late Loss(LL): In-stent, In-segment, Proximal, and Distal | Segment | 0.20 mm | Standard Deviation 0.5 |
Secondary
Mean Lesion Length
The lesion length will be measured by QCA.
Time frame: Pre-procedure
Population: ITT population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Mean Lesion Length | 17.38 mm | Standard Deviation 10.27 |
Secondary
Mean Net Gain: In-stent, In-segment
Late procedural outcome is influenced by both the acute gain provided by the intervention (pre to post) and the subsequent late loss that occurs after the intervention (post to follow-up).The net gain is thus the sum of the offsetting effects of acute gain and late loss (net gain = acute gain - late loss).
Time frame: At 8 months, post index procedure
Population: ITT population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Mean Net Gain: In-stent, In-segment | Stent | 1.26 mm | Standard Deviation 0.52 |
| XIENCE Xpedition 2.25 mm Stent Arm | Mean Net Gain: In-stent, In-segment | Segment | 1.04 mm | Standard Deviation 0.62 |
Secondary
Mean Reference Vessel Diameter (RVD)
Reference vessel diameter measured by QCA
Time frame: Immediately after the procedure
Population: ITT population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Mean Reference Vessel Diameter (RVD) | 2.34 mm | Standard Deviation 0.37 |
Secondary
Mean Reference Vessel Diameter (RVD)
Reference vessel diameter measured by QCA
Time frame: During follow-up, at 8 months post procedure
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Mean Reference Vessel Diameter (RVD) | 2.28 mm | Standard Deviation 0.38 |
Secondary
Mean Reference Vessel Diameter (RVD)
Reference vessel diameter measured by QCA
Time frame: Pre-procedure
Population: ITT population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Mean Reference Vessel Diameter (RVD) | 2.04 mm | Standard Deviation 0.36 |
Secondary
Minimum Blood Vessel Diameter
Minimum blood vessel diameter measured by QCA
Time frame: Immediately after the procedure
Population: ITT population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Minimum Blood Vessel Diameter | 2.03 mm | Standard Deviation 0.27 |
Secondary
Minimum Blood Vessel Diameter
Minimum blood vessel diameter measured by QCA
Time frame: During follow-up, at 8 months post procedure
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Minimum Blood Vessel Diameter | 1.54 mm | Standard Deviation 0.51 |
Secondary
Minimum Blood Vessel Diameter
Minimum blood vessel diameter measured by QCA
Time frame: Pre-procedure
Population: ITT population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Minimum Blood Vessel Diameter | 0.55 mm | Standard Deviation 0.34 |
Secondary
Number of Participants Using Antiplatelet Therapy
Number of patients using aspirin, clopidogrel, ticlopidine, cilostazol,prasugrel, compounding agents and other agents.
Time frame: 3 years observation day from the procedure day
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants Using Antiplatelet Therapy | Aspirin + clopidogrel | 29 Participants |
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants Using Antiplatelet Therapy | Aspirin + ticlopidine | 1 Participants |
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants Using Antiplatelet Therapy | Aspirin | 60 Participants |
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants Using Antiplatelet Therapy | Clopidogrel | 31 Participants |
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants Using Antiplatelet Therapy | Ticlodipine | 1 Participants |
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants Using Antiplatelet Therapy | Cilostazol | 2 Participants |
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants Using Antiplatelet Therapy | Prasugrel | 4 Participants |
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants Using Antiplatelet Therapy | Compounding agent | 4 Participants |
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants Using Antiplatelet Therapy | Other | 1 Participants |
Secondary
Number of Participants Using Antiplatelet Therapy
Number of patients using aspirin, clopidogrel, ticlopidine, cilostazol,prasugrel, compounding agents and other agents.
Time frame: 4 years observation day from the procedure day
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants Using Antiplatelet Therapy | Other | 1 Participants |
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants Using Antiplatelet Therapy | Aspirin + clopidogrel | 26 Participants |
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants Using Antiplatelet Therapy | Aspirin + ticlopidine | 1 Participants |
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants Using Antiplatelet Therapy | Aspirin | 59 Participants |
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants Using Antiplatelet Therapy | Clopidogrel | 27 Participants |
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants Using Antiplatelet Therapy | Prasugrel | 3 Participants |
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants Using Antiplatelet Therapy | Ticlodipine | 1 Participants |
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants Using Antiplatelet Therapy | Cilostazol | 2 Participants |
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants Using Antiplatelet Therapy | Compounding agent | 4 Participants |
Secondary
Number of Participants Using Antiplatelet Therapy
Number of patients using aspirin, clopidogrel, ticlopidine, cilostazol,prasugrel, compounding agents and other agents.
Time frame: 5 years observation day from the procedure day
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants Using Antiplatelet Therapy | Aspirin + clopidogrel | 23 Participants |
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants Using Antiplatelet Therapy | Aspirin + ticlopidine | 1 Participants |
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants Using Antiplatelet Therapy | Aspirin | 52 Participants |
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants Using Antiplatelet Therapy | Clopidogrel | 23 Participants |
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants Using Antiplatelet Therapy | Prasugrel | 4 Participants |
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants Using Antiplatelet Therapy | Ticlodipine | 1 Participants |
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants Using Antiplatelet Therapy | Cilostazol | 2 Participants |
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants Using Antiplatelet Therapy | Compounding agent | 3 Participants |
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants Using Antiplatelet Therapy | Other | 1 Participants |
Secondary
Number of Participants Using Antiplatelet Therapy
Number of patients using aspirin, clopidogrel, ticlopidine, cilostazol,prasugrel, compounding agents and other agents.
Time frame: 2 years observation day from the procedure day
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants Using Antiplatelet Therapy | Aspirin + clopidogrel | 31 Participants |
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants Using Antiplatelet Therapy | Aspirin + ticlopidine | 1 Participants |
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants Using Antiplatelet Therapy | Aspirin | 64 Participants |
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants Using Antiplatelet Therapy | Clopidogrel | 33 Participants |
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants Using Antiplatelet Therapy | Ticlodipine | 1 Participants |
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants Using Antiplatelet Therapy | Cilostazol | 2 Participants |
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants Using Antiplatelet Therapy | Prasugrel | 4 Participants |
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants Using Antiplatelet Therapy | Compounding agent | 4 Participants |
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants Using Antiplatelet Therapy | Other | 1 Participants |
Secondary
Number of Participants Using Antiplatelet Therapy
Number of patients using aspirin, clopidogrel, ticlopidine, cilostazol,prasugrel, compounding agents and other agents.
Time frame: At baseline before procedure
Population: ITT population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants Using Antiplatelet Therapy | Aspirin + clopidogrel | 68 Participants |
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants Using Antiplatelet Therapy | Aspirin + ticlopidine | 2 Participants |
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants Using Antiplatelet Therapy | Aspirin | 92 Participants |
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants Using Antiplatelet Therapy | Clopidogrel | 67 Participants |
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants Using Antiplatelet Therapy | Ticlodipine | 2 Participants |
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants Using Antiplatelet Therapy | Cilostazol | 3 Participants |
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants Using Antiplatelet Therapy | Prasugrel | 25 Participants |
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants Using Antiplatelet Therapy | Compounding agent | 6 Participants |
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants Using Antiplatelet Therapy | Other | 2 Participants |
Secondary
Number of Participants Using Antiplatelet Therapy
Number of patients using aspirin, clopidogrel, ticlopidine, cilostazol,prasugrel, compounding agents and other agents.
Time frame: Date of discharge from procedure day
Population: ITT population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants Using Antiplatelet Therapy | Ticlodipine | 2 Participants |
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants Using Antiplatelet Therapy | Cilostazol | 2 Participants |
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants Using Antiplatelet Therapy | Prasugrel | 17 Participants |
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants Using Antiplatelet Therapy | Aspirin + clopidogrel | 62 Participants |
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants Using Antiplatelet Therapy | Aspirin + ticlopidine | 2 Participants |
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants Using Antiplatelet Therapy | Aspirin | 79 Participants |
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants Using Antiplatelet Therapy | Clopidogrel | 61 Participants |
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants Using Antiplatelet Therapy | Compounding agent | 6 Participants |
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants Using Antiplatelet Therapy | Other | 2 Participants |
Secondary
Number of Participants Using Antiplatelet Therapy
Number of patients using aspirin, clopidogrel, ticlopidine, cilostazol,prasugrel, compounding agents and other agents.
Time frame: 1 year observation day from the procedure day
Population: ITT population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants Using Antiplatelet Therapy | Aspirin + clopidogrel | 43 Participants |
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants Using Antiplatelet Therapy | Aspirin + ticlopidine | 1 Participants |
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants Using Antiplatelet Therapy | Aspirin | 67 Participants |
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants Using Antiplatelet Therapy | Clopidogrel | 44 Participants |
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants Using Antiplatelet Therapy | Ticlodipine | 1 Participants |
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants Using Antiplatelet Therapy | Cilostazol | 2 Participants |
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants Using Antiplatelet Therapy | Prasugrel | 6 Participants |
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants Using Antiplatelet Therapy | Compounding agent | 4 Participants |
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants Using Antiplatelet Therapy | Other | 1 Participants |
Secondary
Number of Participants Using Antiplatelet Therapy
Number of patients using aspirin, clopidogrel, ticlopidine, cilostazol,prasugrel, compounding agents and other agents.
Time frame: 8 months observation day from the procedure day
Population: ITT population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants Using Antiplatelet Therapy | Aspirin + clopidogrel | 54 Participants |
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants Using Antiplatelet Therapy | Aspirin + ticlopidine | 2 Participants |
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants Using Antiplatelet Therapy | Aspirin | 70 Participants |
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants Using Antiplatelet Therapy | Clopidogrel | 52 Participants |
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants Using Antiplatelet Therapy | Ticlodipine | 2 Participants |
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants Using Antiplatelet Therapy | Cilostazol | 2 Participants |
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants Using Antiplatelet Therapy | Prasugrel | 7 Participants |
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants Using Antiplatelet Therapy | Compounding agent | 5 Participants |
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants Using Antiplatelet Therapy | Other | 1 Participants |
Secondary
Number of Participants With All Revascularization
All revascularization endpoint is comprised of TLR, TVR excluding TLR, and non-TVR.
Time frame: During hospitalization
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants With All Revascularization | 2 Participants |
Secondary
Number of Participants With All Revascularization
All revascularization endpoint is comprised of TLR, TVR excluding TLR, and non-TVR.
Time frame: 0 to 3 years
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants With All Revascularization | 41 Participants |
Secondary
Number of Participants With All Revascularization
All revascularization endpoint is comprised of TLR, TVR excluding TLR, and non-TVR.
Time frame: 0 to 4 years
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants With All Revascularization | 42 Participants |
Secondary
Number of Participants With All Revascularization
All revascularization endpoint is comprised of TLR, TVR excluding TLR, and non-TVR.
Time frame: 0 to 5 years
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants With All Revascularization | 44 Participants |
Secondary
Number of Participants With All Revascularization
All revascularization endpoint is comprised of TLR, TVR excluding TLR, and non-TVR.
Time frame: 0 to 2 years
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants With All Revascularization | 38 Participants |
Secondary
Number of Participants With All Revascularization
All revascularization endpoint is comprised of TLR, TVR excluding TLR, and non-TVR.
Time frame: 0 to 8 months
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants With All Revascularization | 23 Participants |
Secondary
Number of Participants With All Revascularization
All revascularization endpoint is comprised of TLR, TVR excluding TLR, and non-TVR.
Time frame: 0 to 1 year
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants With All Revascularization | 29 Participants |
Secondary
Number of Participants With Cardiac Death
Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)
Time frame: 0 to 8 months
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants With Cardiac Death | 0 Participants |
Secondary
Number of Participants With Cardiac Death
Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)
Time frame: 0 to 5 years
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants With Cardiac Death | 0 Participants |
Secondary
Number of Participants With Cardiac Death
Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)
Time frame: 0 to 4 years
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants With Cardiac Death | 0 Participants |
Secondary
Number of Participants With Cardiac Death
Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)
Time frame: 0 to 3 Years
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants With Cardiac Death | 0 Participants |
Secondary
Number of Participants With Cardiac Death
Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)
Time frame: 0 to 2 years
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants With Cardiac Death | 0 Participants |
Secondary
Number of Participants With Cardiac Death
Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)
Time frame: 0 to 1 year
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants With Cardiac Death | 0 Participants |
Secondary
Number of Participants With Cardiac Death
Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)
Time frame: During hospitalization
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants With Cardiac Death | 0 Participants |
Secondary
Number of Participants With Cardiac Death/All MI
All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI
Time frame: 0 to 5 years
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants With Cardiac Death/All MI | 2 Participants |
Secondary
Number of Participants With Cardiac Death/All MI
All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI
Time frame: 0 to 4 years
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants With Cardiac Death/All MI | 2 Participants |
Secondary
Number of Participants With Cardiac Death/All MI
All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI
Time frame: 0 to 3 years
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants With Cardiac Death/All MI | 1 Participants |
Secondary
Number of Participants With Cardiac Death/All MI
All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI
Time frame: 0 to 2 years
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants With Cardiac Death/All MI | 1 Participants |
Secondary
Number of Participants With Cardiac Death/All MI
All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI
Time frame: 0 to 1 year
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants With Cardiac Death/All MI | 1 Participants |
Secondary
Number of Participants With Cardiac Death/All MI
All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI
Time frame: 0 to 8 months
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants With Cardiac Death/All MI | 0 Participants |
Secondary
Number of Participants With Cardiac Death/All MI
All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI
Time frame: During hospitalization
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants With Cardiac Death/All MI | 0 Participants |
Secondary
Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Events-MACE)
Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).
Time frame: 0 to 8 months
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Events-MACE) | 1 Participants |
Secondary
Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Events-MACE)
Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).
Time frame: During hospitalization
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Events-MACE) | 0 Participants |
Secondary
Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Events-MACE)
Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).
Time frame: 0 to 5 years
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Events-MACE) | 8 Participants |
Secondary
Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Events-MACE)
Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).
Time frame: 0 to 4 years
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Events-MACE) | 8 Participants |
Secondary
Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Events-MACE)
Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).
Time frame: 0 to 3 years
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Events-MACE) | 7 Participants |
Secondary
Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Events-MACE)
Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).
Time frame: 0 to 2 years
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Events-MACE) | 5 Participants |
Secondary
Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Events-MACE)
Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).
Time frame: 0 to 1 year
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Events-MACE) | 4 Participants |
Secondary
Number of Participants With Cardiac Death or Target-Vessel MI
Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery).
Time frame: 0 to 3 years
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants With Cardiac Death or Target-Vessel MI | 0 Participants |
Secondary
Number of Participants With Cardiac Death or Target-Vessel MI
Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery).
Time frame: 0 to 4 years
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants With Cardiac Death or Target-Vessel MI | 0 Participants |
Secondary
Number of Participants With Cardiac Death or Target-Vessel MI
Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery).
Time frame: During hospitalization
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants With Cardiac Death or Target-Vessel MI | 0 Participants |
Secondary
Number of Participants With Cardiac Death or Target-Vessel MI
Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery).
Time frame: 0 to 8 months
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants With Cardiac Death or Target-Vessel MI | 0 Participants |
Secondary
Number of Participants With Cardiac Death or Target-Vessel MI
Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery).
Time frame: 0 to 1 year
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants With Cardiac Death or Target-Vessel MI | 0 Participants |
Secondary
Number of Participants With Cardiac Death or Target-Vessel MI
Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery).
Time frame: 0 to 2 years
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants With Cardiac Death or Target-Vessel MI | 0 Participants |
Secondary
Number of Participants With Cardiac Death or Target-Vessel MI
Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery).
Time frame: 0 to 5 years
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants With Cardiac Death or Target-Vessel MI | 0 Participants |
Secondary
Number of Participants With Death
All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. * Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. * Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. * Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Time frame: 0 to 8 months
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants With Death | 0 Participants |
Secondary
Number of Participants With Death
All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. * Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. * Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. * Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Time frame: During hospitalization
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants With Death | 0 Participants |
Secondary
Number of Participants With Death
All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. * Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. * Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. * Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Time frame: 0 to 1 year
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants With Death | 1 Participants |
Secondary
Number of Participants With Death
All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. * Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. * Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. * Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Time frame: 0 to 2 years
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants With Death | 4 Participants |
Secondary
Number of Participants With Death
All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. * Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. * Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. * Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Time frame: 0 to 3 years
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants With Death | 7 Participants |
Secondary
Number of Participants With Death
All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. * Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. * Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. * Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Time frame: 0 to 4 years
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants With Death | 8 Participants |
Secondary
Number of Participants With Death
All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. * Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. * Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. * Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Time frame: 0 to 5 years
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants With Death | 9 Participants |
Secondary
Number of Participants With Death/All MI
All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI
Time frame: During hospitalization
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants With Death/All MI | 0 Participants |
Secondary
Number of Participants With Death/All MI
All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI
Time frame: 0 to 5 years
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants With Death/All MI | 11 Participants |
Secondary
Number of Participants With Death/All MI
All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI
Time frame: 0 to 4 years
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants With Death/All MI | 10 Participants |
Secondary
Number of Participants With Death/All MI
All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI
Time frame: 0 to 3 years
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants With Death/All MI | 8 Participants |
Secondary
Number of Participants With Death/All MI
All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI
Time frame: 0 to 2 years
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants With Death/All MI | 5 Participants |
Secondary
Number of Participants With Death/All MI
All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI
Time frame: 0 to 1 year
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants With Death/All MI | 2 Participants |
Secondary
Number of Participants With Death/All MI
All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI
Time frame: 0 to 8 months
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants With Death/All MI | 0 Participants |
Secondary
Number of Participants With Death,Myocardial Infarction and Revascularization (DMR)
DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.
Time frame: 0 to 4 years
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants With Death,Myocardial Infarction and Revascularization (DMR) | 48 Participants |
Secondary
Number of Participants With Death,Myocardial Infarction and Revascularization (DMR)
DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.
Time frame: During hospitalization
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants With Death,Myocardial Infarction and Revascularization (DMR) | 2 Participants |
Secondary
Number of Participants With Death,Myocardial Infarction and Revascularization (DMR)
DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.
Time frame: 0 to 8 months
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants With Death,Myocardial Infarction and Revascularization (DMR) | 23 Participants |
Secondary
Number of Participants With Death,Myocardial Infarction and Revascularization (DMR)
DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.
Time frame: 0 to 1 year
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants With Death,Myocardial Infarction and Revascularization (DMR) | 29 Participants |
Secondary
Number of Participants With Death,Myocardial Infarction and Revascularization (DMR)
DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.
Time frame: 0 to 2 years
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants With Death,Myocardial Infarction and Revascularization (DMR) | 41 Participants |
Secondary
Number of Participants With Death,Myocardial Infarction and Revascularization (DMR)
DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.
Time frame: 0 to 3 years
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants With Death,Myocardial Infarction and Revascularization (DMR) | 47 Participants |
Secondary
Number of Participants With Death,Myocardial Infarction and Revascularization (DMR)
DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.
Time frame: 0 to 5 years
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants With Death,Myocardial Infarction and Revascularization (DMR) | 50 Participants |
Secondary
Number of Participants With MI Related to Target Vessel
Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves
Time frame: 0 to 1 year
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants With MI Related to Target Vessel | 0 Participants |
Secondary
Number of Participants With MI Related to Target Vessel
Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves
Time frame: During hospitalization
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants With MI Related to Target Vessel | 0 Participants |
Secondary
Number of Participants With MI Related to Target Vessel
Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves
Time frame: 0 to 8 months
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants With MI Related to Target Vessel | 0 Participants |
Secondary
Number of Participants With MI Related to Target Vessel
Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves
Time frame: 0 to 5 years
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants With MI Related to Target Vessel | 0 Participants |
Secondary
Number of Participants With MI Related to Target Vessel
Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves
Time frame: 0 to 2 years
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants With MI Related to Target Vessel | 0 Participants |
Secondary
Number of Participants With MI Related to Target Vessel
Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves
Time frame: 0 to 3 years
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants With MI Related to Target Vessel | 0 Participants |
Secondary
Number of Participants With MI Related to Target Vessel
Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves
Time frame: 0 to 4 years
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants With MI Related to Target Vessel | 0 Participants |
Secondary
Number of Participants With Myocardial Infarction
Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves
Time frame: 0 to 5 years
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants With Myocardial Infarction | 1 Participants |
Secondary
Number of Participants With Myocardial Infarction
Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves
Time frame: 0 to 4 years
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants With Myocardial Infarction | 1 Participants |
Secondary
Number of Participants With Myocardial Infarction
Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves
Time frame: 0 to 3 years
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants With Myocardial Infarction | 1 Participants |
Secondary
Number of Participants With Myocardial Infarction
Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves
Time frame: 0 to 2 years
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants With Myocardial Infarction | 1 Participants |
Secondary
Number of Participants With Myocardial Infarction
Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves
Time frame: 0 to 1 year
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants With Myocardial Infarction | 1 Participants |
Secondary
Number of Participants With Myocardial Infarction
Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves
Time frame: 0 to 8 months
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants With Myocardial Infarction | 0 Participants |
Secondary
Number of Participants With Myocardial Infarction
Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Time frame: During hospitalization
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants With Myocardial Infarction | 0 Participants |
Secondary
Number of Participants With Target Lesion Failure (TLF)
TLF is defined as composite of Cardiac Death, Myocardial Infarction (per protocol-defined MI definition), attributable to Target Vessel (TV-MI), or Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Time frame: During hospitalization
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants With Target Lesion Failure (TLF) | 0 Participants |
Secondary
Number of Participants With Target Lesion Failure (TLF)
TLF is defined as composite of Cardiac Death, Myocardial Infarction (per protocol-defined MI definition), attributable to Target Vessel (TV-MI), or Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Time frame: 0 to 8 months
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants With Target Lesion Failure (TLF) | 1 Participants |
Secondary
Number of Participants With Target Lesion Failure (TLF)
TLF is defined as composite of Cardiac Death, Myocardial Infarction (per protocol-defined MI definition), attributable to Target Vessel (TV-MI), or Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Time frame: 0 to 1 year
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants With Target Lesion Failure (TLF) | 3 Participants |
Secondary
Number of Participants With Target Lesion Failure (TLF)
TLF is defined as composite of Cardiac Death, Myocardial Infarction (per protocol-defined MI definition), attributable to Target Vessel (TV-MI), or Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Time frame: 0 to 2 years
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants With Target Lesion Failure (TLF) | 4 Participants |
Secondary
Number of Participants With Target Lesion Failure (TLF)
TLF is defined as composite of Cardiac Death, Myocardial Infarction (per protocol-defined MI definition), attributable to Target Vessel (TV-MI), or Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Time frame: 0 to 3 years
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants With Target Lesion Failure (TLF) | 6 Participants |
Secondary
Number of Participants With Target Lesion Failure (TLF)
TLF is defined as composite of Cardiac Death, Myocardial Infarction (per protocol-defined MI definition), attributable to Target Vessel (TV-MI), or Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Time frame: 0 to 4 years
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants With Target Lesion Failure (TLF) | 6 Participants |
Secondary
Number of Participants With Target Lesion Failure (TLF)
TLF is defined as composite of Cardiac Death, Myocardial Infarction (per protocol-defined MI definition), attributable to Target Vessel (TV-MI), or Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Time frame: 0 to 5 years
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants With Target Lesion Failure (TLF) | 6 Participants |
Secondary
Number of Participants With Target Lesion Revascularization Based on Ischemia Findings
Target lesion revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion.
Time frame: 0 to 2 years
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants With Target Lesion Revascularization Based on Ischemia Findings | 4 Participants |
Secondary
Number of Participants With Target Lesion Revascularization Based on Ischemia Findings
Target lesion revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion.
Time frame: 0 to 5 years
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants With Target Lesion Revascularization Based on Ischemia Findings | 6 Participants |
Secondary
Number of Participants With Target Lesion Revascularization Based on Ischemia Findings
Target lesion revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion.
Time frame: 0 to 1 year
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants With Target Lesion Revascularization Based on Ischemia Findings | 3 Participants |
Secondary
Number of Participants With Target Lesion Revascularization Based on Ischemia Findings
Target lesion revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion.
Time frame: 0 to 8 months
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants With Target Lesion Revascularization Based on Ischemia Findings | 1 Participants |
Secondary
Number of Participants With Target Lesion Revascularization Based on Ischemia Findings
Target lesion revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion.
Time frame: During hospitalization
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants With Target Lesion Revascularization Based on Ischemia Findings | 0 Participants |
Secondary
Number of Participants With Target Lesion Revascularization Based on Ischemia Findings
Target lesion revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion.
Time frame: 0 to 4 years
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants With Target Lesion Revascularization Based on Ischemia Findings | 6 Participants |
Secondary
Number of Participants With Target Lesion Revascularization Based on Ischemia Findings
Target lesion revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion.
Time frame: 0 to 3 years
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants With Target Lesion Revascularization Based on Ischemia Findings | 6 Participants |
Secondary
Number of Participants With Target Vessel Failure (TVF)
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Time frame: During hospitalization
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants With Target Vessel Failure (TVF) | 0 Participants |
Secondary
Number of Participants With Target Vessel Failure (TVF)
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Time frame: 0 to 5 years
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants With Target Vessel Failure (TVF) | 11 Participants |
Secondary
Number of Participants With Target Vessel Failure (TVF)
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Time frame: 0 to 4 years
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants With Target Vessel Failure (TVF) | 10 Participants |
Secondary
Number of Participants With Target Vessel Failure (TVF)
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Time frame: 0 to 3 years
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants With Target Vessel Failure (TVF) | 9 Participants |
Secondary
Number of Participants With Target Vessel Failure (TVF)
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Time frame: 0 to 2 years
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants With Target Vessel Failure (TVF) | 7 Participants |
Secondary
Number of Participants With Target Vessel Failure (TVF)
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Time frame: 0 to 1 year
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants With Target Vessel Failure (TVF) | 6 Participants |
Secondary
Number of Participants With Target Vessel Failure (TVF)
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Time frame: 0 to 8 months
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants With Target Vessel Failure (TVF) | 2 Participants |
Secondary
Number of Participants With Target Vessel Revascularization (Non-TLR)
Target vessel revascularization (TVR) includes ischemia driven TVR, non-TLR and non- ischemia driven TVR, non-TLR.
Time frame: During hospitalization
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants With Target Vessel Revascularization (Non-TLR) | 2 Participants |
Secondary
Number of Participants With Target Vessel Revascularization (Non-TLR)
Target vessel revascularization (TVR) includes ischemia driven TVR, non-TLR and non- ischemia driven TVR, non-TLR.
Time frame: 0 to 5 years
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants With Target Vessel Revascularization (Non-TLR) | 13 Participants |
Secondary
Number of Participants With Target Vessel Revascularization (Non-TLR)
Target vessel revascularization (TVR) includes ischemia driven TVR, non-TLR and non- ischemia driven TVR, non-TLR.
Time frame: 0 to 4 years
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants With Target Vessel Revascularization (Non-TLR) | 12 Participants |
Secondary
Number of Participants With Target Vessel Revascularization (Non-TLR)
Target vessel revascularization (TVR) includes ischemia driven TVR, non-TLR and non- ischemia driven TVR, non-TLR.
Time frame: 0 to 3 years
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants With Target Vessel Revascularization (Non-TLR) | 11 Participants |
Secondary
Number of Participants With Target Vessel Revascularization (Non-TLR)
Target vessel revascularization (TVR) includes ischemia driven TVR, non-TLR and non- ischemia driven TVR, non-TLR.
Time frame: 0 to 2 years
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants With Target Vessel Revascularization (Non-TLR) | 9 Participants |
Secondary
Number of Participants With Target Vessel Revascularization (Non-TLR)
Target vessel revascularization (TVR) includes ischemia driven TVR, non-TLR and non- ischemia driven TVR, non-TLR.
Time frame: 0 to 1 year
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants With Target Vessel Revascularization (Non-TLR) | 7 Participants |
Secondary
Number of Participants With Target Vessel Revascularization (Non-TLR)
Target vessel revascularization (TVR) includes ischemia driven TVR, non-TLR and non- ischemia driven TVR, non-TLR.
Time frame: 0 to 8 months
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants With Target Vessel Revascularization (Non-TLR) | 6 Participants |
Secondary
Number of Participants With Target Vessel Revascularization (TLR or TVR (Non-TLR))
Target vessel revascularization (TLR or TVR, non-TLR) includes ischemia driven TVR (TLR or TVR, non-TLR) or non-ischemia driven TVR (TLR or TVR, nonTLR).
Time frame: 0 to 8 months
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants With Target Vessel Revascularization (TLR or TVR (Non-TLR)) | 11 Participants |
Secondary
Number of Participants With Target Vessel Revascularization (TLR or TVR (Non-TLR))
Target vessel revascularization (TLR or TVR, non-TLR) includes ischemia driven TVR (TLR or TVR, non-TLR) or non-ischemia driven TVR (TLR or TVR, nonTLR).
Time frame: 0 to 2 years
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants With Target Vessel Revascularization (TLR or TVR (Non-TLR)) | 19 Participants |
Secondary
Number of Participants With Target Vessel Revascularization (TLR or TVR (Non-TLR))
Target vessel revascularization (TLR or TVR, non-TLR) includes ischemia driven TVR (TLR or TVR, non-TLR) or non-ischemia driven TVR (TLR or TVR, nonTLR).
Time frame: 0 to 1 year
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants With Target Vessel Revascularization (TLR or TVR (Non-TLR)) | 16 Participants |
Secondary
Number of Participants With Target Vessel Revascularization (TLR or TVR (Non-TLR))
Target vessel revascularization (TLR or TVR, non-TLR) includes ischemia driven TVR (TLR or TVR, non-TLR) or non-ischemia driven TVR (TLR or TVR, nonTLR).
Time frame: During hospitalization
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants With Target Vessel Revascularization (TLR or TVR (Non-TLR)) | 2 Participants |
Secondary
Number of Participants With Target Vessel Revascularization (TLR or TVR (Non-TLR))
Target vessel revascularization (TLR or TVR, non-TLR) includes ischemia driven TVR (TLR or TVR, non-TLR) or non-ischemia driven TVR (TLR or TVR, nonTLR).
Time frame: 0 to 5 years
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants With Target Vessel Revascularization (TLR or TVR (Non-TLR)) | 24 Participants |
Secondary
Number of Participants With Target Vessel Revascularization (TLR or TVR (Non-TLR))
Target vessel revascularization (TLR or TVR, non-TLR) includes ischemia driven TVR (TLR or TVR, non-TLR) or non-ischemia driven TVR (TLR or TVR, nonTLR).
Time frame: 0 to 4 years
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants With Target Vessel Revascularization (TLR or TVR (Non-TLR)) | 23 Participants |
Secondary
Number of Participants With Target Vessel Revascularization (TLR or TVR (Non-TLR))
Target vessel revascularization (TLR or TVR, non-TLR) includes ischemia driven TVR (TLR or TVR, non-TLR) or non-ischemia driven TVR (TLR or TVR, nonTLR).
Time frame: 0 to 3 years
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Number of Participants With Target Vessel Revascularization (TLR or TVR (Non-TLR)) | 22 Participants |
Secondary
Percent Diameter Stenosis (%DS)
In-segment, In-stent, Proximal and Distal. The value calculated as 100 \* (1 - minimum lumen diameter/reference vessel diameter) (MLD/RVD) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).
Time frame: Pre-procedure
Population: ITT population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Percent Diameter Stenosis (%DS) | 72.02 Percent Diameter stenosis | Standard Deviation 16.97 |
Secondary
Percent Diameter Stenosis (%DS)
In-segment, In-stent, Proximal and Distal. The value calculated as 100 \* (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).
Time frame: Immediately after the procedure
Population: ITT population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Percent Diameter Stenosis (%DS) | 23.15 Percent Diameter stenosis | Standard Deviation 12.01 |
Secondary
Percent Diameter Stenosis (%DS)
In-segment, In-stent, Proximal and Distal. The value calculated as 100 \* (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).
Time frame: During follow-up, at 8 months post procedure
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| XIENCE Xpedition 2.25 mm Stent Arm | Percent Diameter Stenosis (%DS) | 32.14 Percent Diameter Stenosis | Standard Deviation 20.43 |