Coronary Artery Disease, Coronary Artery Stenosis, Coronary Disease, Coronary Restenosis, Myocardial Ischemia
Conditions
Keywords
drug eluting stents, stents, Angioplasty, myocardial ischemia, coronary artery stenosis, Coronary Disease, Coronary Artery Disease, Coronary Restenosis, Long lesion
Brief summary
To evaluate the safety and effectiveness of the XIENCE PRIME and XIENCE PRIME Long Lesion (LL) Everolimus Eluting Coronary Stent System (EECSS) in improving coronary luminal diameter in subjects with symptomatic heart disease due to a maximum of two de novo native coronary artery lesions, each in a different epicardial vessel.
Interventions
DEVICECore size Xience Prime
Core size includes a range of stent sizes.
DEVICEXience Prime Long Lesion (LL)
Long lesion stent sizes include a range of sizes.
Sponsors
Abbott Medical Devices
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject must be at least 18 years of age. 2. Subject or a legally authorized representative must provide written informed consent prior to any study related procedure, per site requirements. 3. Subject must have evidence of myocardial ischemia (e.g., stable or unstable angina, silent ischemia, positive functional study or a reversible change in the electrocardiogram (ECG) consistent with ischemia). 4. Subject must be an acceptable candidate for coronary artery bypass graft (CABG) surgery. 5. Subject must agree to undergo all protocol-required follow-up procedures. 6. Subject must agree not to participate in any other clinical study for a period of one year following the index procedure. Angiographic Inclusion Criteria 1. One or two de novo target lesions each in a different epicardial vessel. 2. If there are two target lesions, both lesions must satisfy the angiographic eligibility criteria for that registry. o Multiple focal de novo lesions in a target vessel that can be covered by a single stent are allowed. 3. The target lesion(s) must be located in a major artery or branch with a visually estimated diameter stenosis of ≥ 50% and \< 100% with a TIMI flow of ≥ 1. 4. Target lesion(s) must be located in a native coronary artery with reference vessel diameter (RVD) by visual estimation of: * ≥ 2.25 mm and ≤ 4.25 mm for treatment by the core size XIENCE PRIME EECS * ≥ 2.5 mm and ≤ 4.25 mm for treatment by the XIENCE PRIME LL EECS 5. Target lesion(s) must be located in a native coronary artery with length by visual estimation of: * ≤ 22 mm for treatment by the core size XIENCE PRIME EECS * \> 22 mm and ≤ 32 mm for treatment by the XIENCE PRIME LL EECS
Exclusion criteria
1. Subject has had a known diagnosis of acute myocardial infarction (AMI) preceding the index procedure (CK-MB ≥ 2 times upper limit of normal) and CK and CK-MB have not returned to within normal limits at the time of procedure. 2. The subject is currently experiencing clinical symptoms consistent with new onset AMI, such as nitrate-unresponsive prolonged chest pain with ischemic ECG changes. 3. Subject has current unstable cardiac arrhythmias associated with hemodynamic instability. 4. Subject has a known left ventricular ejection fraction (LVEF) \< 30% (LVEF may be obtained at the time of the index procedure if the value is unknown and if necessary). 5. Subject has received coronary brachytherapy in any epicardial vessel (target or non target). 6. Subject has received any organ transplant or is on a waiting list for any organ transplant. 7. Subject is receiving or scheduled to receive chemotherapy for malignancy within 30 days prior to or within one year after the index procedure. 8. Subject is receiving or scheduled to receive planned radiotherapy to the chest/mediastinum. 9. Subject is receiving immunosuppressant therapy or has known immunosuppressive or autoimmune disease (e.g. human immunodeficiency virus, systemic lupus erythematosus etc.). 10. Subject is receiving chronic anticoagulation therapy (e.g., heparin, coumadin). 11. Subject will require Low Molecular Weight Heparin (LMWH) post-procedure. 12. Subject has a known hypersensitivity or contraindication to aspirin, heparin/bivalirudin, clopidogrel/ticlopidine, everolimus, cobalt, chromium, nickel, tungsten, acrylic and fluoro polymers or contrast sensitivity that cannot be adequately pre-medicated. 13. Elective surgery is planned within 12 months after the procedure that will require discontinuing either aspirin or clopidogrel. 14. Subject has a platelet count \< 100,000 cells/mm3 or \> 700,000 cells/mm3, a white blood cell (WBC) of \< 3,000 cells/mm3, or documented or suspected liver disease (including laboratory evidence of hepatitis). 15. Subject has known renal insufficiency (examples being but not limited to estimated glomerular filtration rate (eGFR) \< 60 ml/kg/m2, serum creatinine level ≥ 2.5 mg/dL, or on dialysis). 16. Subject has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions. 17. Subject has had a cerebrovascular accident/stroke or transient ischemic neurological attack (TIA) within the past six months. 18. Subject has had a significant gastro-intestinal or significant urinary bleed within the past six months. 19. Subject has extensive peripheral vascular disease that precludes safe 6 French sheath insertion. 20. Subject has other medical illness (e.g., cancer or congestive heart failure) or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance with the protocol, confound the data interpretation or is associated with a limited life expectancy (i.e., less than one year). 21. Subject is currently participating in another clinical study that has not yet completed its primary endpoint. 22. Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure. Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test. Angiographic
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Target Lesion Failure (TLF) | 1 year | The composite rate of: Cardiac Death Target Vessel Myocardial Infarction (TV-MI) and Clinically Indicated Target Lesion Revascularization (CI-TLR) per protocol. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Device Success (Lesion Basis) | From the start of index procedure to end of index procedure | Device success is defined as achievement of a final in-stent residual diameter stenosis of \< 50% (by QCA). |
| Procedural Success (Subject Basis) | From the start of index procedure to end of index procedure | Procedure success is defined as achievement of a final in-stent diameter stenosis of \< 50% (by QCA). Per Protocol. |
| All Death (Cardiac, Vascular, Non-cardiovascular) | In-hospital is less than or equal to 7 days post index procedure | — |
| Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel) | In-hospital is defined as hospitalization less than or equal to 7 days post index procedure. | Per Protocol |
| Non-target Vessel MI (Q-wave, Non Q-wave) | In-hospital is defined as hospitalization less than or equal to 7 days post index procedure | Per Protocol |
| Clinically Indicated-Target Lesion Revascularization | In-hospital is defined as hospitalization less than or equal to 7 days post index procedure | — |
| Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV) | In-hospital is defined as hospitalization less than or equal to 7 days post index procedure | — |
| Procedure Time | From insertion to withdrawal of guide catheter | Procedure time is defined as time between insertion and withdrawal of guide catheter. |
| All TVR (CI and Non-CI) | In-hospital is defined as hospitalization less than or equal to 7 days post index procedure | — |
| All Coronary Revascularization (TVR and Non-TVR) | In-hospital is defined as hospitalization less than or equal to 7 days post index procedure | — |
| Cardiac Death/All MI | In-hospital is defined as hospitalization less than or equal to 7 days post index procedure | — |
| Cardiac Death/ All MI | 30 days | Per Protocol |
| Cardiac Death/ All MI/CI-TLR | in-hospital | — |
| All Death/All MI/All Coronary Revascularization | In-hospital is defined as hospitalization less than or equal to 7 days post index procedure | Per Protocol |
| Stent Thrombosis | Acute (≤1 day) | Per protocol and per Academic Research Consortium (ARC, definite/probable) |
| All TLR (CI and Non-CI) | In-hospital is defined as hospitalization less than or equal to 7 days post index procedure | — |
Countries
Australia, United States
Participant flow
Recruitment details
Subjects enrolled into this trial will be male and female subjects from the general interventional cardiology population. The study commenced on June 5, 2009 with the first subject enrolled on June 15, 2009. The last subject in the CSR was enrolled February 12, 2010, and the last subject enrolled in LLR was on April 6, 2010.
Pre-assignment details
Intention-to-treat (ITT) set includes 525 subjects: 415 in core size registry (CSR) arm and 110 in long lesion registry (LLR) arm. Full analysis set (FAS) (n=505, 401 in CSR arm and 104 in LLR arm) includes subjects who have received at least 1 of the following: the core size XIENCE PRIME or XIENCE PRIME LL stent system, including bailout.
Participants by arm
| Arm | Count |
|---|---|
| Core Size Registry Core size indicates the range of diameters of the stents used. | 401 |
| Long Lesion Registry Use of long lesion stents. | 104 |
| Total | 505 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 3 | 1 |
| Overall Study | Physician Decision | 0 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | Core Size Registry | Long Lesion Registry | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 167 Participants | 48 Participants | 215 Participants |
| Age, Categorical Between 18 and 65 years | 234 Participants | 56 Participants | 290 Participants |
| Age, Continuous | 62.70 years STANDARD_DEVIATION 10.23 | 63.46 years STANDARD_DEVIATION 9.44 | 62.86 years STANDARD_DEVIATION 10.07 |
| Region of Enrollment Australia | 25 participants | 8 participants | 33 participants |
| Region of Enrollment United States | 376 participants | 96 participants | 472 participants |
| Sex: Female, Male Female | 119 Participants | 39 Participants | 158 Participants |
| Sex: Female, Male Male | 282 Participants | 65 Participants | 347 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 222 / 412 | 51 / 110 |
| serious Total, serious adverse events | 203 / 412 | 49 / 110 |
Outcome results
Primary
Target Lesion Failure (TLF)
The composite rate of: Cardiac Death Target Vessel Myocardial Infarction (TV-MI) and Clinically Indicated Target Lesion Revascularization (CI-TLR) per protocol.
Time frame: 1 year
Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Core Size Registry | Target Lesion Failure (TLF) | 4.5 percentage of participants |
| Long Lesion Registry | Target Lesion Failure (TLF) | 7.7 percentage of participants |
Primary
Target Lesion Failure (TLF)
The composite rate of: Cardiac Death Target Vessel Myocardial Infarction (TV-MI) and Clinically Indicated Target Lesion Revascularization (CI-TLR) per protocol.
Time frame: 2 years
Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Core Size Registry | Target Lesion Failure (TLF) | 6.4 percentage of participants |
| Long Lesion Registry | Target Lesion Failure (TLF) | 9.6 percentage of participants |
Primary
Target Lesion Failure (TLF)
The composite rate of: Cardiac Death Target Vessel Myocardial Infarction (TV-MI) and Clinically Indicated Target Lesion Revascularization (CI-TLR) per protocol.
Time frame: 3 years
Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Core Size Registry | Target Lesion Failure (TLF) | 8.5 percentage of participants |
| Long Lesion Registry | Target Lesion Failure (TLF) | 9.6 percentage of participants |
Secondary
All Coronary Revascularization (TVR and Non-TVR)
Time frame: 1 year
Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Core Size Registry | All Coronary Revascularization (TVR and Non-TVR) | 6.8 percentage of participants |
| Long Lesion Registry | All Coronary Revascularization (TVR and Non-TVR) | 8.7 percentage of participants |
Secondary
All Coronary Revascularization (TVR and Non-TVR)
Time frame: 180 days
Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Core Size Registry | All Coronary Revascularization (TVR and Non-TVR) | 4.8 percentage of participants |
| Long Lesion Registry | All Coronary Revascularization (TVR and Non-TVR) | 6.7 percentage of participants |
Secondary
All Coronary Revascularization (TVR and Non-TVR)
Time frame: 30 days
Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Core Size Registry | All Coronary Revascularization (TVR and Non-TVR) | 1.5 percentage of participants |
| Long Lesion Registry | All Coronary Revascularization (TVR and Non-TVR) | 3.8 percentage of participants |
Secondary
All Coronary Revascularization (TVR and Non-TVR)
Time frame: In-hospital is defined as hospitalization less than or equal to 7 days post index procedure
Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Core Size Registry | All Coronary Revascularization (TVR and Non-TVR) | 0.5 percentage of participants |
| Long Lesion Registry | All Coronary Revascularization (TVR and Non-TVR) | 1.0 percentage of participants |
Secondary
All Coronary Revascularization (TVR and Non-TVR)
Time frame: 3 years
Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Core Size Registry | All Coronary Revascularization (TVR and Non-TVR) | 14.9 percentage of participants |
| Long Lesion Registry | All Coronary Revascularization (TVR and Non-TVR) | 14.4 percentage of participants |
Secondary
All Coronary Revascularization (TVR and Non-TVR)
Time frame: 2 years
Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Core Size Registry | All Coronary Revascularization (TVR and Non-TVR) | 10.5 percentage of participants |
| Long Lesion Registry | All Coronary Revascularization (TVR and Non-TVR) | 13.5 percentage of participants |
Secondary
All Death/All MI/All Coronary Revascularization
Per Protocol
Time frame: 3 years
Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Core Size Registry | All Death/All MI/All Coronary Revascularization | 19 percentage of participants |
| Long Lesion Registry | All Death/All MI/All Coronary Revascularization | 20.2 percentage of participants |
Secondary
All Death/All MI/All Coronary Revascularization
Per Protocol
Time frame: 2 years
Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Core Size Registry | All Death/All MI/All Coronary Revascularization | 13.8 percentage of participants |
| Long Lesion Registry | All Death/All MI/All Coronary Revascularization | 20.2 percentage of participants |
Secondary
All Death/All MI/All Coronary Revascularization
Per Protocol
Time frame: 1 year
Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Core Size Registry | All Death/All MI/All Coronary Revascularization | 9.0 percentage of participants |
| Long Lesion Registry | All Death/All MI/All Coronary Revascularization | 14.4 percentage of participants |
Secondary
All Death/All MI/All Coronary Revascularization
Per Protocol
Time frame: 180 days
Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Core Size Registry | All Death/All MI/All Coronary Revascularization | 7.0 percentage of participants |
| Long Lesion Registry | All Death/All MI/All Coronary Revascularization | 11.5 percentage of participants |
Secondary
All Death/All MI/All Coronary Revascularization
Per Protocol
Time frame: 30 days
Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Core Size Registry | All Death/All MI/All Coronary Revascularization | 3.2 percentage of participants |
| Long Lesion Registry | All Death/All MI/All Coronary Revascularization | 8.7 percentage of participants |
Secondary
All Death/All MI/All Coronary Revascularization
Per Protocol
Time frame: In-hospital is defined as hospitalization less than or equal to 7 days post index procedure
Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Core Size Registry | All Death/All MI/All Coronary Revascularization | 2.2 percentage of participants |
| Long Lesion Registry | All Death/All MI/All Coronary Revascularization | 5.8 percentage of participants |
Secondary
All Death (Cardiac, Vascular, Non-cardiovascular)
Time frame: 180 days
Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Core Size Registry | All Death (Cardiac, Vascular, Non-cardiovascular) | 0.5 percentage of participants |
| Long Lesion Registry | All Death (Cardiac, Vascular, Non-cardiovascular) | 0.0 percentage of participants |
Secondary
All Death (Cardiac, Vascular, Non-cardiovascular)
Time frame: 30 days
Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Core Size Registry | All Death (Cardiac, Vascular, Non-cardiovascular) | 0.0 percentage of participants |
| Long Lesion Registry | All Death (Cardiac, Vascular, Non-cardiovascular) | 0.0 percentage of participants |
Secondary
All Death (Cardiac, Vascular, Non-cardiovascular)
Time frame: 3 years
Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Core Size Registry | All Death (Cardiac, Vascular, Non-cardiovascular) | 3.1 percentage of participants |
| Long Lesion Registry | All Death (Cardiac, Vascular, Non-cardiovascular) | 2.9 percentage of participants |
Secondary
All Death (Cardiac, Vascular, Non-cardiovascular)
Time frame: 2 years
Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Core Size Registry | All Death (Cardiac, Vascular, Non-cardiovascular) | 2.0 percentage of participants |
| Long Lesion Registry | All Death (Cardiac, Vascular, Non-cardiovascular) | 2.9 percentage of participants |
Secondary
All Death (Cardiac, Vascular, Non-cardiovascular)
Time frame: 1 year
Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Core Size Registry | All Death (Cardiac, Vascular, Non-cardiovascular) | 0.8 percentage of participants |
| Long Lesion Registry | All Death (Cardiac, Vascular, Non-cardiovascular) | 1.0 percentage of participants |
Secondary
All Death (Cardiac, Vascular, Non-cardiovascular)
Time frame: In-hospital is less than or equal to 7 days post index procedure
Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Core Size Registry | All Death (Cardiac, Vascular, Non-cardiovascular) | 0.0 percentage of participants |
| Long Lesion Registry | All Death (Cardiac, Vascular, Non-cardiovascular) | 0.0 percentage of participants |
Secondary
All TLR (CI and Non-CI)
Time frame: 30 days
Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Core Size Registry | All TLR (CI and Non-CI) | 0.5 percentage of participants |
| Long Lesion Registry | All TLR (CI and Non-CI) | 1.0 percentage of participants |
Secondary
All TLR (CI and Non-CI)
Time frame: 3 years
Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Core Size Registry | All TLR (CI and Non-CI) | 5.6 percentage of participants |
| Long Lesion Registry | All TLR (CI and Non-CI) | 4.8 percentage of participants |
Secondary
All TLR (CI and Non-CI)
Time frame: 2 years
Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Core Size Registry | All TLR (CI and Non-CI) | 4.3 percentage of participants |
| Long Lesion Registry | All TLR (CI and Non-CI) | 4.8 percentage of participants |
Secondary
All TLR (CI and Non-CI)
Time frame: 1 year
Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Core Size Registry | All TLR (CI and Non-CI) | 2.8 percentage of participants |
| Long Lesion Registry | All TLR (CI and Non-CI) | 2.9 percentage of participants |
Secondary
All TLR (CI and Non-CI)
Time frame: 180 days
Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Core Size Registry | All TLR (CI and Non-CI) | 2.0 percentage of participants |
| Long Lesion Registry | All TLR (CI and Non-CI) | 1.9 percentage of participants |
Secondary
All TLR (CI and Non-CI)
Time frame: In-hospital is defined as hospitalization less than or equal to 7 days post index procedure
Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Core Size Registry | All TLR (CI and Non-CI) | 0.2 percentage of participants |
| Long Lesion Registry | All TLR (CI and Non-CI) | 1.0 percentage of participants |
Secondary
All TVR (CI and Non-CI)
Time frame: 180 days
Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Core Size Registry | All TVR (CI and Non-CI) | 3.5 percentage of participants |
| Long Lesion Registry | All TVR (CI and Non-CI) | 3.8 percentage of participants |
Secondary
All TVR (CI and Non-CI)
Time frame: 3 years
Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Core Size Registry | All TVR (CI and Non-CI) | 10 percentage of participants |
| Long Lesion Registry | All TVR (CI and Non-CI) | 7.7 percentage of participants |
Secondary
All TVR (CI and Non-CI)
Time frame: In-hospital is defined as hospitalization less than or equal to 7 days post index procedure
Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Core Size Registry | All TVR (CI and Non-CI) | 0.5 percentage of participants |
| Long Lesion Registry | All TVR (CI and Non-CI) | 1.0 percentage of participants |
Secondary
All TVR (CI and Non-CI)
Time frame: 30 days
Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Core Size Registry | All TVR (CI and Non-CI) | 1.2 percentage of participants |
| Long Lesion Registry | All TVR (CI and Non-CI) | 1.9 percentage of participants |
Secondary
All TVR (CI and Non-CI)
Time frame: 1 year
Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Core Size Registry | All TVR (CI and Non-CI) | 4.8 percentage of participants |
| Long Lesion Registry | All TVR (CI and Non-CI) | 4.8 percentage of participants |
Secondary
All TVR (CI and Non-CI)
Time frame: 2 years
Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Core Size Registry | All TVR (CI and Non-CI) | 7.1 percentage of participants |
| Long Lesion Registry | All TVR (CI and Non-CI) | 7.7 percentage of participants |
Secondary
Cardiac Death/ All MI
Per Protocol
Time frame: 30 days
Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Core Size Registry | Cardiac Death/ All MI | 1.7 percentage of participants |
| Long Lesion Registry | Cardiac Death/ All MI | 4.8 percentage of participants |
Secondary
Cardiac Death/All MI
Per Protocol
Time frame: 180 days
Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Core Size Registry | Cardiac Death/All MI | 2.0 percentage of participants |
| Long Lesion Registry | Cardiac Death/All MI | 4.8 percentage of participants |
Secondary
Cardiac Death/All MI
Time frame: In-hospital is defined as hospitalization less than or equal to 7 days post index procedure
Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Core Size Registry | Cardiac Death/All MI | 1.7 percentage of participants |
| Long Lesion Registry | Cardiac Death/All MI | 4.8 percentage of participants |
Secondary
Cardiac Death/All MI
Per Protocol
Time frame: 2 years
Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Core Size Registry | Cardiac Death/All MI | 2.6 percentage of participants |
| Long Lesion Registry | Cardiac Death/All MI | 5.8 percentage of participants |
Secondary
Cardiac Death/All MI
Per Protocol
Time frame: 1 year
Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Core Size Registry | Cardiac Death/All MI | 2.0 percentage of participants |
| Long Lesion Registry | Cardiac Death/All MI | 4.8 percentage of participants |
Secondary
Cardiac Death/All MI
Per Protocol
Time frame: 3 years
Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Core Size Registry | Cardiac Death/All MI | 3.8 percentage of participants |
| Long Lesion Registry | Cardiac Death/All MI | 5.8 percentage of participants |
Secondary
Cardiac Death/ All MI/CI-TLR
Per Protocol
Time frame: 180 days
Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Core Size Registry | Cardiac Death/ All MI/CI-TLR | 3.8 percentage of participants |
| Long Lesion Registry | Cardiac Death/ All MI/CI-TLR | 6.7 percentage of participants |
Secondary
Cardiac Death/ All MI/CI-TLR
Per Protocol
Time frame: 30 days
Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Core Size Registry | Cardiac Death/ All MI/CI-TLR | 2.2 percentage of participants |
| Long Lesion Registry | Cardiac Death/ All MI/CI-TLR | 5.8 percentage of participants |
Secondary
Cardiac Death/ All MI/CI-TLR
Per Protocol
Time frame: 3 years
Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Core Size Registry | Cardiac Death/ All MI/CI-TLR | 9.0 percentage of participants |
| Long Lesion Registry | Cardiac Death/ All MI/CI-TLR | 10.6 percentage of participants |
Secondary
Cardiac Death/ All MI/CI-TLR
Per Protocol
Time frame: 2 years
Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Core Size Registry | Cardiac Death/ All MI/CI-TLR | 6.6 percentage of participants |
| Long Lesion Registry | Cardiac Death/ All MI/CI-TLR | 10.6 percentage of participants |
Secondary
Cardiac Death/ All MI/CI-TLR
Per Protocol
Time frame: 1 year
Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Core Size Registry | Cardiac Death/ All MI/CI-TLR | 4.5 percentage of participants |
| Long Lesion Registry | Cardiac Death/ All MI/CI-TLR | 7.7 percentage of participants |
Secondary
Cardiac Death/ All MI/CI-TLR
Time frame: in-hospital
Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Core Size Registry | Cardiac Death/ All MI/CI-TLR | 2.0 percentage of participants |
| Long Lesion Registry | Cardiac Death/ All MI/CI-TLR | 5.8 percentage of participants |
Secondary
Clinically Indicated-Target Lesion Revascularization
Time frame: 2 years
Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Core Size Registry | Clinically Indicated-Target Lesion Revascularization | 4.1 percentage of participants |
| Long Lesion Registry | Clinically Indicated-Target Lesion Revascularization | 4.8 percentage of participants |
Secondary
Clinically Indicated-Target Lesion Revascularization
Time frame: In-hospital is defined as hospitalization less than or equal to 7 days post index procedure
Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Core Size Registry | Clinically Indicated-Target Lesion Revascularization | 0.2 percentage of participants |
| Long Lesion Registry | Clinically Indicated-Target Lesion Revascularization | 1.0 percentage of participants |
Secondary
Clinically Indicated-Target Lesion Revascularization
Time frame: 3 years
Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Core Size Registry | Clinically Indicated-Target Lesion Revascularization | 5.4 percentage of participants |
| Long Lesion Registry | Clinically Indicated-Target Lesion Revascularization | 4.8 percentage of participants |
Secondary
Clinically Indicated-Target Lesion Revascularization
Time frame: 30 days
Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Core Size Registry | Clinically Indicated-Target Lesion Revascularization | 0.5 percentage of participants |
| Long Lesion Registry | Clinically Indicated-Target Lesion Revascularization | 1.0 percentage of participants |
Secondary
Clinically Indicated-Target Lesion Revascularization
Time frame: 180 days
Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Core Size Registry | Clinically Indicated-Target Lesion Revascularization | 1.8 percentage of participants |
| Long Lesion Registry | Clinically Indicated-Target Lesion Revascularization | 1.9 percentage of participants |
Secondary
Clinically Indicated-Target Lesion Revascularization
Time frame: 1 year
Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Core Size Registry | Clinically Indicated-Target Lesion Revascularization | 2.5 percentage of participants |
| Long Lesion Registry | Clinically Indicated-Target Lesion Revascularization | 2.9 percentage of participants |
Secondary
Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV)
Time frame: 1 year
Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Core Size Registry | Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV) | 4.5 percentage of participants |
| Long Lesion Registry | Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV) | 4.8 percentage of participants |
Secondary
Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV)
Time frame: 3 years
Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Core Size Registry | Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV) | 9.5 percentage of participants |
| Long Lesion Registry | Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV) | 7.7 percentage of participants |
Secondary
Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV)
Time frame: 2 years
Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Core Size Registry | Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV) | 6.9 percentage of participants |
| Long Lesion Registry | Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV) | 7.7 percentage of participants |
Secondary
Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV)
Time frame: In-hospital is defined as hospitalization less than or equal to 7 days post index procedure
Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Core Size Registry | Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV) | 0.5 percentage of participants |
| Long Lesion Registry | Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV) | 1.0 percentage of participants |
Secondary
Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV)
Time frame: 30 days
Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Core Size Registry | Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV) | 1.2 percentage of participants |
| Long Lesion Registry | Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV) | 1.9 percentage of participants |
Secondary
Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV)
Time frame: 180 days
Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Core Size Registry | Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV) | 3.3 percentage of participants |
| Long Lesion Registry | Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV) | 3.8 percentage of participants |
Secondary
Device Success (Lesion Basis)
Device success is defined as achievement of a final in-stent residual diameter stenosis of \< 50% (by QCA).
Time frame: From the start of index procedure to end of index procedure
Population: The analysis was done to include only subjects with post index procedure cardiac enzyme data in window (between 8 hours post index procedure and hospital discharge). Therefore, the final analysis contained 403 ITT CSR subjects and 106 ITT LLR subjects.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Core Size Registry | Device Success (Lesion Basis) | 98.2 percentage of lesions |
| Long Lesion Registry | Device Success (Lesion Basis) | 97.6 percentage of lesions |
Secondary
Non-target Vessel MI (Q-wave, Non Q-wave)
Per Protocol
Time frame: 2 years
Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Core Size Registry | Non-target Vessel MI (Q-wave, Non Q-wave) | 0.3 percentage of participants |
| Long Lesion Registry | Non-target Vessel MI (Q-wave, Non Q-wave) | 1.9 percentage of participants |
Secondary
Non-target Vessel MI (Q-wave, Non Q-wave)
Per Protocol
Time frame: In-hospital is defined as hospitalization less than or equal to 7 days post index procedure
Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Core Size Registry | Non-target Vessel MI (Q-wave, Non Q-wave) | 0.0 percentage of participants |
| Long Lesion Registry | Non-target Vessel MI (Q-wave, Non Q-wave) | 0.0 percentage of participants |
Secondary
Non-target Vessel MI (Q-wave, Non Q-wave)
Per Protocol
Time frame: 30 days
Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Core Size Registry | Non-target Vessel MI (Q-wave, Non Q-wave) | 0.0 percentage of participants |
| Long Lesion Registry | Non-target Vessel MI (Q-wave, Non Q-wave) | 0.0 percentage of participants |
Secondary
Non-target Vessel MI (Q-wave, Non Q-wave)
Per Protocol
Time frame: 180 days
Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Core Size Registry | Non-target Vessel MI (Q-wave, Non Q-wave) | 0.0 percentage of participants |
| Long Lesion Registry | Non-target Vessel MI (Q-wave, Non Q-wave) | 0.0 percentage of participants |
Secondary
Non-target Vessel MI (Q-wave, Non Q-wave)
Per Protocol
Time frame: 1 year
Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Core Size Registry | Non-target Vessel MI (Q-wave, Non Q-wave) | 0.0 percentage of participants |
| Long Lesion Registry | Non-target Vessel MI (Q-wave, Non Q-wave) | 0.0 percentage of participants |
Secondary
Non-target Vessel MI (Q-wave, Non Q-wave)
Per Protocol
Time frame: 3 years
Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Core Size Registry | Non-target Vessel MI (Q-wave, Non Q-wave) | 0.8 percentage of participants |
| Long Lesion Registry | Non-target Vessel MI (Q-wave, Non Q-wave) | 1.9 percentage of participants |
Secondary
Procedural Success (Subject Basis)
Procedure success is defined as achievement of a final in-stent diameter stenosis of \< 50% (by QCA). Per Protocol.
Time frame: From the start of index procedure to end of index procedure
Population: The analysis was done to include only subjects with post index procedure cardiac enzyme data in window (between 8 hours post index procedure and hospital discharge). Out of these subjects, 2 in the CSR and 1 in the LLR did not have QCA data and therefore were excluded. So, the final analysis contained 401 ITT CSR subjects and 105 ITT LLR subjects.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Core Size Registry | Procedural Success (Subject Basis) | 97.8 percentage of participants |
| Long Lesion Registry | Procedural Success (Subject Basis) | 94.3 percentage of participants |
Secondary
Procedure Time
Procedure time is defined as time between insertion and withdrawal of guide catheter.
Time frame: From insertion to withdrawal of guide catheter
Population: The analysis was done to include only subjects with post index procedure cardiac enzyme data in window (between 8 hours post index procedure and hospital discharge). Therefore, the final analysis contained 403 ITT CSR subjects and 106 ITT LLR subjects.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Core Size Registry | Procedure Time | 32.6 Minutes | Standard Deviation 21.1 |
| Long Lesion Registry | Procedure Time | 46.9 Minutes | Standard Deviation 30.9 |
Secondary
Stent Thrombosis
Per ARC, definite and probable
Time frame: Overall (0 - 1123 days)
Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Core Size Registry | Stent Thrombosis | 0.8 percentage of participants |
| Long Lesion Registry | Stent Thrombosis | 0 percentage of participants |
Secondary
Stent Thrombosis
Per ARC, definite and probable
Time frame: Very Late (394 - 758 days)
Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Core Size Registry | Stent Thrombosis | 0.0 percentage of participants |
| Long Lesion Registry | Stent Thrombosis | 0.0 percentage of participants |
Secondary
Stent Thrombosis
Per protocol
Time frame: Late (31 - 1123 days)
Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Core Size Registry | Stent Thrombosis | 0.5 percentage of participants |
| Long Lesion Registry | Stent Thrombosis | 0.0 percentage of participants |
Secondary
Stent Thrombosis
Per protocol and per ARC
Time frame: Overall (0-393 days)
Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Core Size Registry | Stent Thrombosis | Per ARC | 0.5 percentage of participants |
| Core Size Registry | Stent Thrombosis | Per Protocol | 0.5 percentage of participants |
| Long Lesion Registry | Stent Thrombosis | Per ARC | 0.0 percentage of participants |
| Long Lesion Registry | Stent Thrombosis | Per Protocol | 0.0 percentage of participants |
Secondary
Stent Thrombosis
Per protocol
Time frame: Overall (0-758 days)
Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Core Size Registry | Stent Thrombosis | 0.8 percentage of participants |
| Long Lesion Registry | Stent Thrombosis | 0.0 percentage of participants |
Secondary
Stent Thrombosis
Per ARC, definite and probable
Time frame: Overall (0-758 days)
Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Core Size Registry | Stent Thrombosis | 0.5 percentage of participants |
| Long Lesion Registry | Stent Thrombosis | 0 percentage of participants |
Secondary
Stent Thrombosis
Per protocol
Time frame: Overall (0 - 1123 days)
Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Core Size Registry | Stent Thrombosis | 1.1 percentage of participants |
| Long Lesion Registry | Stent Thrombosis | 0.0 percentage of participants |
Secondary
Stent Thrombosis
Per protocol and per Academic Research Consortium (ARC, definite/probable)
Time frame: Acute (≤1 day)
Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Core Size Registry | Stent Thrombosis | Per ARC | 0.5 percentage of participants |
| Core Size Registry | Stent Thrombosis | Per Protocol | 0.5 percentage of participants |
| Long Lesion Registry | Stent Thrombosis | Per ARC | 0.0 percentage of participants |
| Long Lesion Registry | Stent Thrombosis | Per Protocol | 0.0 percentage of participants |
Secondary
Stent Thrombosis
Per protocol and per ARC
Time frame: Subacute (>1 - 30 days)
Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Core Size Registry | Stent Thrombosis | Per ARC | 0.0 percentage of participants |
| Core Size Registry | Stent Thrombosis | Per Protocol | 0.0 percentage of participants |
| Long Lesion Registry | Stent Thrombosis | Per ARC | 0.0 percentage of participants |
| Long Lesion Registry | Stent Thrombosis | Per Protocol | 0.0 percentage of participants |
Secondary
Stent Thrombosis
Per protocol and per ARC
Time frame: Acute/Subacute (0 - 30 days)
Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Core Size Registry | Stent Thrombosis | Per ARC | 0.5 percentage of participants |
| Core Size Registry | Stent Thrombosis | Per Protocol | 0.5 percentage of participants |
| Long Lesion Registry | Stent Thrombosis | Per ARC | 0.0 percentage of participants |
| Long Lesion Registry | Stent Thrombosis | Per Protocol | 0.0 percentage of participants |
Secondary
Stent Thrombosis
Per protocol and per ARC
Time frame: Late (31 - 393 days)
Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Core Size Registry | Stent Thrombosis | Per ARC | 0.0 percentage of participants |
| Core Size Registry | Stent Thrombosis | Per Protocol | 0.0 percentage of participants |
| Long Lesion Registry | Stent Thrombosis | Per ARC | 0.0 percentage of participants |
| Long Lesion Registry | Stent Thrombosis | Per Protocol | 0.0 percentage of participants |
Secondary
Stent Thrombosis
Per protocol
Time frame: Late (31 - 758 days)
Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Core Size Registry | Stent Thrombosis | 0.3 percentage of participants |
| Long Lesion Registry | Stent Thrombosis | 0.0 percentage of participants |
Secondary
Stent Thrombosis
Per ARC, definite and probable
Time frame: Very Late (394 - 1123 days)
Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Core Size Registry | Stent Thrombosis | 0.3 percentage of participants |
| Long Lesion Registry | Stent Thrombosis | 0 percentage of participants |
Secondary
Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel)
Per Protocol
Time frame: 180 days
Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Core Size Registry | Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel) | 1.8 percentage of participants |
| Long Lesion Registry | Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel) | 4.8 percentage of participants |
Secondary
Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel)
Per Protocol
Time frame: 30 days
Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Core Size Registry | Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel) | 1.7 percentage of participants |
| Long Lesion Registry | Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel) | 4.8 percentage of participants |
Secondary
Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel)
Per Protocol
Time frame: In-hospital is defined as hospitalization less than or equal to 7 days post index procedure.
Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Core Size Registry | Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel) | 1.7 percentage of participants |
| Long Lesion Registry | Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel) | 4.8 percentage of participants |
Secondary
Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel)
Per Protocol
Time frame: 2 years
Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Core Size Registry | Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel) | 1.8 percentage of participants |
| Long Lesion Registry | Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel) | 4.8 percentage of participants |
Secondary
Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel)
Per Protocol
Time frame: 3 years
Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Core Size Registry | Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel) | 2.6 percentage of participants |
| Long Lesion Registry | Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel) | 4.8 percentage of participants |
Secondary
Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel)
Per Protocol
Time frame: 1 year
Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Core Size Registry | Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel) | 1.8 percentage of participants |
| Long Lesion Registry | Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel) | 4.8 percentage of participants |