Atherosclerosis, Coronary Artery Disease
Conditions
Keywords
Atherosclerosis, Coronary Artery Disease
Brief summary
Compile acute (30-day) clinical outcomes data and 9-month angiographic and intravascular ultrasound (IVUS) data for the PROMUS Element™ Everolimus- Eluting Coronary Stent System in the treatment of patients with a single de novo atherosclerotic lesion
Interventions
DEVICEPROMUS Element™
Drug eluting coronary stent system
Sponsors
Boston Scientific Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient (or legal guardian) understands the study requirements and the treatment procedures and provides written informed consent before any study-specific tests or procedures are performed * Patient is eligible for percutaneous coronary intervention (PCI) * Patient has documented stable angina pectoris (Canadian Cardiovascular Society \[CCS\] Classification 1, 2, 3, or 4) or documented silent ischemia; or unstable angina pectoris (Braunwald Class IB-C, IIB-C, or IIIB-C) * Patient is an acceptable candidate for coronary artery bypass grafting (CABG) * Patient has a left ventricular ejection fraction (LVEF) \>=30% as measured within 30 days prior to enrollment * Patient is willing to comply with all specified follow-up evaluations Angiographic Inclusion Criteria: * Target lesion must be a de novo lesion located in a native coronary artery with visually estimated diameter of \>=2.25 mm and \<=4.25 mm * Target lesion length must measure (by visual estimate) \<=34 mm * Target lesion must be in a major coronary artery or branch with visually estimated stenosis \>=50% and \<100% with Thrombolysis in Myocardial Infarction (TIMI) flow \>1.
Exclusion criteria
* Patient has clinical symptoms and/or electrocardiogram (ECG) changes consistent with acute myocardial infarction (MI) * Patient has had a known diagnosis of recent MI (within 30 days prior to the index procedure) and has elevated enzymes at the time of the index procedure as follows. * Patients are excluded if any of the following criteria are met at the time of the index procedure * If creatine kinase, MB band (CK-MB) \>2× upper limit of normal (ULN), the patient is excluded regardless of the creatine kinase (CK) Total. * If CK-MB is 1-2× ULN, the patient is excluded if the CK Total is \>2× ULN. * If CK Total/CK-MB are not used and Troponin is, the patients are excluded if the following criterion is met at the time of the index procedure. * Troponin \>1× ULN with at least one of the following. * Patient has ischemic symptoms and electrocardiogram (ECG) changes indicative of ongoing ischemia (e.g., \>1mm ST segment elevation or depression in consecutive leads or new left bundle branch block \[LBBB\]); * Development of pathological Q-waves in the ECG * Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality. Note: For patients who have had a recent MI, CK Total/CK-MB (or Troponin if CK Total/CK-MB are not used) must be documented prior to enrolling the patient * Patient has received an organ transplant or is on a waiting list for an organ * transplant * Patient is receiving or scheduled to receive chemotherapy within 30 days before or after the index procedure * Patient is receiving oral or intravenous immunosuppressive therapy (ie, inhaled steroids are not excluded) or has known life-limiting immunosuppressive or autoimmune disease (e.g., human immunodeficiency virus, systemic lupus erythematosus, but not including diabetes mellitus) * Patient is receiving chronic (\>=72 hours) anticoagulation therapy (eg, heparin, coumadin) for indications other than acute coronary syndrome * Patient has a platelet count \<100,000 cells/mm3 or \>700,000 cells/mm3 * Patient has a white blood cell (WBC) count \<3,000 cells/mm3 * Patient has documented or suspected liver disease, including laboratory evidence of hepatitis * Patient is on dialysis or has known renal insufficiency (i.e., estimated creatinine clearance \<50 mL/min by the Cockcroft Gault formula, ie \[(140-age)\*lean body weight (in kg)\]/\[plasma creatinine (mg/dL)\*72\]) * Patient has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions * Patient has had a cerebrovascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months, or has any permanent neurologic defect that may cause non-compliance with the protocol * Target vessel or side branch has been treated with any type of percutaneous coronary intervention (PCI; eg, balloon angioplasty, stent, cutting balloon, atherectomy) within 12 months prior to the index procedure * Target vessel has been treated within 10 mm proximal or distal to the target lesion (by visual estimate) with any type of PCI (eg, balloon angioplasty, stent, cutting balloon, atherectomy) at any time prior to the index procedure * Non-target vessel or side branch has been treated with any type of PCI (eg, balloon angioplasty, stent, cutting balloon, atherectomy) within 24 hours prior to the index procedure * Planned or actual target vessel treatment with an unapproved device, directional or rotational coronary atherectomy, laser, cutting balloon or transluminal extraction catheter immediately prior to stent placement * Planned percutaneous coronary intervention or coronary artery bypass grafting after the index procedure * Patient previously treated at any time with coronary intravascular brachytherapy * Patient has a known allergy to the study stent system or protocol-required concomitant medications (e.g., stainless steel, platinum, cobalt, chromium, nickel, tungsten, acrylic, fluoropolymers, everolimus, thienopyridines, aspirin, contrast) that cannot be adequately premedicated * Patient has active peptic ulcer or active gastrointestinal (GI) bleeding * Patient has one of the following: * Other serious medical illness (eg, cancer, congestive heart failure) that may reduce life expectancy to less than 24 months * Current problems with substance abuse (eg, alcohol, cocaine, heroin, etc.) * Planned procedure that may cause non-compliance with the protocol or confound data interpretation * Patient is participating in another investigational drug or device clinical trial that has not reached its primary endpoint * Patient intends to participate in another investigational drug or device clinical trial within 12 months after the index procedure * Known intention to procreate within 12 months after the index procedure * Female with positive pregnancy test within 7 days prior to the index procedure (a pregnancy test must be performed in women of child-bearing potential prior to enrollment), or lactating * Patient has more than 1 target lesion or more than 1 target lesion and 1 non-target lesion, identified during screening for intervention Angiographic
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cardiac Events (Composite) | 30 days | Percentage of patients who had a myocardial infarction, cardiac death, target lesion revascularization, or stent thrombosis (defined as definite or probable per the Academic Research Consortium \[ARC\] definitions); see below for definitions of individual components. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| In-stent Late Loss | 9 months | In-stent late loss by quantitative coronary angiography in workhorse target lesions (visual reference vessel diameter \[RVD\] ≥2.5 mm and ≤4.25 mm and visual lesion length ≤24 mm) |
| Occurance of Post-procedure Incomplete Stent Apposition | Post-procedure | Percentage of participants who experience incomplete stent apposition as determined immediately post-procedure by intravascular ultrasound |
| Myocardial Infarction (MI) | 12 months | New Q-waves in ≥2 leads lasting ≥0.04 sec with creatine kinase myoglobin band(CK-MB) or troponin \>upper limit of normal(ULN); if no new Q-waves total CK levels \>3×ULN (peri-percutaneous coronary intervention \[PCI\]) or \>2×ULN (spontaneous) with elevated CK-MB or troponin \>3×ULN (peri-PCI) or \>2×ULN (spontaneous) plus ≥one of the following: ECG changes indicating new ischemia (new ST-T changes, left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar for MI diagnosis post coronary artery bypass graft with CK-MB or troponin \>5×ULN |
| All-cause Mortality | 12 months | — |
| Target Vessel Revascularization (TVR) | 30 Days | Target vessel revascularization (TVR) is any ischemia-driven repeat percutaneous intervention to improve blood flow, or bypass surgery of not previously existing lesions with diameter stenosis ≥50% by quantitative coronary angiography in the target vessel, including the target lesion. |
| Target Lesion Revascularization (TLR) | 30 Days | Target lesion revascularization (TLR) is any ischemia-driven repeat percutaneous intervention to improve blood flow of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion. |
| Target Vessel Failure (TVF) | 12 months | Target vessel failure (TVF) is defined as any ischemia-driven revascularization of the target vessel, myocardial infarction (MI, Q-wave and non-Q-wave) related to the target vessel or death related to the target vessel. For the purposes of this protocol, if it cannot be determined with certainty whether the MI or death was related to the target vessel, it will be considered a TVF. |
| Definite + Probable Stent Thrombosis Based on Academic Research Consortium (ARC) Definition | 24 hours | DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: \>24 hours to 30 days post; late ST: \>30 days to 1 year post; Very late ST: \>1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days). |
| Clinical Procedural Success | Duration of hospital stay (usually 1-2 days) | Mean lesion diameter stenosis \< 30% with TIMI 3 flow without the occurrence of in-hospital cardiac death, MI, or TVR |
| Technical Success | Acute-At time of index procedure | Successful delivery and deployment of the study stent to the target lesion, without balloon rupture or embolization, summarized per stent. |
| Target Lesion Failure (TLF) | 12 months | Target lesion failure (TLF) is defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (Q-wave and non-Q-wave) related to the target vessel, or cardiac death related to the target vessel. |
Countries
Australia, Malaysia, New Zealand, Singapore
Participant flow
Recruitment details
Enrollment of 100 subjects was planned, 100 were enrolled at 14 investigative sites in the Asia Pacific region by July 22, 2009.
Participants by arm
| Arm | Count |
|---|---|
| PROMUS Element Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device) | 100 |
| Total | 100 |
Baseline characteristics
| Characteristic | PROMUS Element |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 40 Participants |
| Age, Categorical Between 18 and 65 years | 60 Participants |
| Age Continuous | 61.82 years STANDARD_DEVIATION 9.92 |
| Cardiac History Family History of Coronary Artery Disease | 49 Participant |
| Cardiac History History of Arrhythmia | 4 Participant |
| Cardiac History History of Coronary Artery Bypass Graft | 5 Participant |
| Cardiac History History of Left Main Disease | 2 Participant |
| Cardiac History History of Multivessel Disease | 34 Participant |
| Cardiac History History of Percutaneous Coronary Intervention | 31 Participant |
| Cardiac History No Angina | 5 Participant |
| Cardiac History Previous MI | 39 Participant |
| Cardiac History Silent Ischemia | 2 Participant |
| Cardiac History Stable Angina | 57 Participant |
| Cardiac History Unstable Angina | 38 Participant |
| Cardiac History-Left Ventricular Ejection Fraction | 64.41 Percent ejection fraction STANDARD_DEVIATION 13.3 |
| General Medical History History of Bleeding Disorder | 3 Participant |
| General Medical History Hyperlipidemia Requiring Medication | 81 Participant |
| General Medical History Hypertension Requiring. Medication | 66 Participant |
| General Medical History Medically Treated Diabetes | 19 Participant |
| General Medical History Smoking, Ever | 64 Participant |
| Lesion Characteristic-Diameter Stenosis | 74.09 Percent Diameter Stenosis STANDARD_DEVIATION 10.93 |
| Lesion Characteristics Bend >45% | 12 Lesions |
| Lesion Characteristics Branch Vessel Disease | 6 Lesions |
| Lesion Characteristics Calcification, any | 18 Lesions |
| Lesion Characteristics Eccentric Lesion | 53 Lesions |
| Lesion Characteristics Lesion Length | 15.40 millimeters STANDARD_DEVIATION 7.03 |
| Lesion Characteristics Minimum Lumen Diameter | 0.71 millimeters STANDARD_DEVIATION 0.34 |
| Lesion Characteristics Reference Vessel Diameter | 2.72 millimeters STANDARD_DEVIATION 0.53 |
| Lesion Characteristics Tortuosity | 9 Lesions |
| Lesion Characteristics Total Occlusion | 1 Lesions |
| Lesion Characteristics: American College of Cardiology (ACC)/American Heart Association (AHA) Class A | 5 Lesions |
| Lesion Characteristics: American College of Cardiology (ACC)/American Heart Association (AHA) Class B1 | 28 Lesions |
| Lesion Characteristics: American College of Cardiology (ACC)/American Heart Association (AHA) Class B2 | 42 Lesions |
| Lesion Characteristics: American College of Cardiology (ACC)/American Heart Association (AHA) Class C | 25 Lesions |
| Lesion Characteristic-Target Vessel Left Anterior Descending Artery | 35 Lesion |
| Lesion Characteristic-Target Vessel Left Circumflex Artery | 30 Lesion |
| Lesion Characteristic-Target Vessel Right Coronary Artery | 35 Lesion |
| Lesion Location Distal | 7 Lesions |
| Lesion Location Mid | 54 Lesions |
| Lesion Location Ostial | 2 Lesions |
| Lesion Location Proximal | 37 Lesions |
| Neurologic History History of Cerebrovascular Accident | 3 Participant |
| Neurologic History History of Transient Ischemic Attack | 2 Participant |
| Pre-Procedure Thrombolysis In Myocardial Infarction (TIMI) Flow 0 | 1 Lesion |
| Pre-Procedure Thrombolysis In Myocardial Infarction (TIMI) Flow 1 | 0 Lesion |
| Pre-Procedure Thrombolysis In Myocardial Infarction (TIMI) Flow 2 | 1 Lesion |
| Pre-Procedure Thrombolysis In Myocardial Infarction (TIMI) Flow 3 | 98 Lesion |
| Race/Ethnicity, Customized Asian | 16 Participant |
| Race/Ethnicity, Customized Caucasian | 78 Participant |
| Race/Ethnicity, Customized Maori | 1 Participant |
| Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander | 2 Participant |
| Race/Ethnicity, Customized Other | 3 Participant |
| Region of Enrollment Australia | 49 participants |
| Region of Enrollment Malaysia | 9 participants |
| Region of Enrollment New Zealand | 39 participants |
| Region of Enrollment Singapore | 3 participants |
| Renal and Peripheral History History of Peripheral Vascular Disease | 3 Participant |
| Renal and Peripheral History History of Renal Disease | 1 Participant |
| Sex: Female, Male Female | 23 Participants |
| Sex: Female, Male Male | 77 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 48 / 100 |
| serious Total, serious adverse events | 27 / 100 |
Outcome results
Primary
Cardiac Events (Composite)
Percentage of patients who had a myocardial infarction, cardiac death, target lesion revascularization, or stent thrombosis (defined as definite or probable per the Academic Research Consortium \[ARC\] definitions); see below for definitions of individual components.
Time frame: 30 days
Population: Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PROMUS Element | Cardiac Events (Composite) | 1.0 percentage of participants |
Secondary
All-cause Mortality
Time frame: 12 months
Population: Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PROMUS Element | All-cause Mortality | 0.0 percentage of participants |
Secondary
Clinical Procedural Success
Mean lesion diameter stenosis \< 30% with TIMI 3 flow without the occurrence of in-hospital cardiac death, MI, or TVR
Time frame: Duration of hospital stay (usually 1-2 days)
Population: Analysis was intention to treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PROMUS Element | Clinical Procedural Success | 99.0 percentage of participants |
Secondary
Definite + Probable Stent Thrombosis Based on Academic Research Consortium (ARC) Definition
DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: \>24 hours to 30 days post; late ST: \>30 days to 1 year post; Very late ST: \>1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days).
Time frame: >30 days-1 year
Population: Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PROMUS Element | Definite + Probable Stent Thrombosis Based on Academic Research Consortium (ARC) Definition | 0.0 percentage of participants |
Secondary
Definite + Probable Stent Thrombosis Based on Academic Research Consortium (ARC) Definition
DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: \>24 hours to 30 days post; late ST: \>30 days to 1 year post; Very late ST: \>1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days).
Time frame: 24 hours
Population: Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PROMUS Element | Definite + Probable Stent Thrombosis Based on Academic Research Consortium (ARC) Definition | 1.0 percentage of participants |
Secondary
Definite + Probable Stent Thrombosis Based on Academic Research Consortium (ARC) Definition
DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: \>24 hours to 30 days post; late ST: \>30 days to 1 year post; Very late ST: \>1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days).
Time frame: >24 hr-30 days
Population: Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PROMUS Element | Definite + Probable Stent Thrombosis Based on Academic Research Consortium (ARC) Definition | 0.0 percentage of participants |
Secondary
In-stent Late Loss
In-stent late loss by quantitative coronary angiography in workhorse target lesions (visual reference vessel diameter \[RVD\] ≥2.5 mm and ≤4.25 mm and visual lesion length ≤24 mm)
Time frame: 9 months
Population: Analysis was intention to treat; all patients in the study with workhorse lesions (visual reference vessel diameter \[RVD\] ≥2.5 mm and ≤4.25 mm and visual lesion length ≤24 mm) underwent clinical follow up to provide the information needed for this endpoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PROMUS Element | In-stent Late Loss | 0.17 millimeters | Standard Deviation 0.25 |
Comparison: The Student t-test was used to compare the outcome to a prespecified performance goal of 0.44 mm based on an historical TAXUS Express workhorse 9-month in-stent late loss (0.41 mm) value plus delta (0.03 mm)p-value: <0.0001t-test, 1 sided
Secondary
Myocardial Infarction (MI)
New Q-waves in ≥2 leads lasting ≥0.04 sec with creatine kinase myoglobin band(CK-MB) or troponin \>upper limit of normal(ULN); if no new Q-waves total CK levels \>3×ULN (peri-percutaneous coronary intervention \[PCI\]) or \>2×ULN (spontaneous) with elevated CK-MB or troponin \>3×ULN (peri-PCI) or \>2×ULN (spontaneous) plus ≥one of the following: ECG changes indicating new ischemia (new ST-T changes, left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar for MI diagnosis post coronary artery bypass graft with CK-MB or troponin \>5×ULN
Time frame: 12 months
Population: Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PROMUS Element | Myocardial Infarction (MI) | 0.0 percentage of participants |
Secondary
Occurance of Post-procedure Incomplete Stent Apposition
Percentage of participants who experience incomplete stent apposition as determined immediately post-procedure by intravascular ultrasound
Time frame: Post-procedure
Population: Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device) and who underwent intravascular ultrasound to determine extent of stent apposition
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PROMUS Element | Occurance of Post-procedure Incomplete Stent Apposition | 5.7 percentage of participants |
Comparison: A one-sided 95% Clopper-Pearson upper confidence bound was derived and tested to determine if the outcome was less than a prespecified performance goal based on historical XIENCE V/PROMUS post-procedure incomplete apposition data from the SPIRIT III study (34.4%).p-value: <0.0001One-sided exact binomial test
Secondary
Target Lesion Failure (TLF)
Target lesion failure (TLF) is defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (Q-wave and non-Q-wave) related to the target vessel, or cardiac death related to the target vessel.
Time frame: 12 months
Population: Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PROMUS Element | Target Lesion Failure (TLF) | 1.0 percentage of participants |
Secondary
Target Lesion Revascularization (TLR)
Target lesion revascularization (TLR) is any ischemia-driven repeat percutaneous intervention to improve blood flow of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion.
Time frame: 12 Months
Population: Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PROMUS Element | Target Lesion Revascularization (TLR) | 1.0 percentage of participants |
Secondary
Target Lesion Revascularization (TLR)
Target lesion revascularization (TLR) is any ischemia-driven repeat percutaneous intervention to improve blood flow of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion.
Time frame: 30 Days
Population: Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PROMUS Element | Target Lesion Revascularization (TLR) | 1.0 percentage of participants |
Secondary
Target Vessel Failure (TVF)
Target vessel failure (TVF) is defined as any ischemia-driven revascularization of the target vessel, myocardial infarction (MI, Q-wave and non-Q-wave) related to the target vessel or death related to the target vessel. For the purposes of this protocol, if it cannot be determined with certainty whether the MI or death was related to the target vessel, it will be considered a TVF.
Time frame: 12 months
Population: Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PROMUS Element | Target Vessel Failure (TVF) | 1.0 percentage of participants |
Secondary
Target Vessel Revascularization (TVR)
Target vessel revascularization (TVR) is any ischemia-driven repeat percutaneous intervention to improve blood flow, or bypass surgery of not previously existing lesions with diameter stenosis ≥50% by quantitative coronary angiography in the target vessel, including the target lesion.
Time frame: 12 months
Population: Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PROMUS Element | Target Vessel Revascularization (TVR) | 1.0 percentage of participants |
Secondary
Target Vessel Revascularization (TVR)
Target vessel revascularization (TVR) is any ischemia-driven repeat percutaneous intervention to improve blood flow, or bypass surgery of not previously existing lesions with diameter stenosis ≥50% by quantitative coronary angiography in the target vessel, including the target lesion.
Time frame: 30 Days
Population: Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PROMUS Element | Target Vessel Revascularization (TVR) | 1.0 percentage of participants |
Secondary
Technical Success
Successful delivery and deployment of the study stent to the target lesion, without balloon rupture or embolization, summarized per stent.
Time frame: Acute-At time of index procedure
Population: Intention to treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PROMUS Element | Technical Success | 100.0 percentage of stents attempted |