Acute Coronary Syndrome, Angina Pectoris, Atherosclerosis, Coronary, Coronary Artery Disease, Ischemic Heart Disease, Myocardial Ischemia
Conditions
Keywords
Drug eluting coronary stents, Sirolimus, Bioabsorbable polymer, DES
Brief summary
The objective of this post-approval study is to confirm that the clinical performance of the Orsiro stent in a real-world setting is similar to the clinical performance observed for Orsiro in the BIOFLOW-V Investigational Device Exemption pivotal trial, as a condition of the US Food and Drug Administration (FDA) approval (P170030).
Detailed description
BIOFLOW-VII is a prospective, multicenter, single-arm study. Subjects with coronary artery disease (CAD) who undergo an on-label percutaneous coronary intervention (PCI) with a placed Orsiro stent within the prior 24 hours will be screened post-index procedure per the protocol inclusion and exclusion criteria. Following the index procedure and study enrollment, subjects will be followed for 5 years. The follow-up schedule will include an intermediate study visit at 1 month, a primary endpoint study visit at 12 months, and long-term study visits at 2, 3, 4, and 5 years.
Interventions
DEVICEOrsiro DES
Orsiro is a device/drug combination product composed of two components, a device (coronary stent system including a cobalt chromium stent platform), and a drug product (a formulation of sirolimus) contained in a bioabsorbable polymer coating.
Sponsors
Biotronik, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject is ≥18 years of age. 2. Subject was an acceptable candidate for treatment with a drug eluting stent at the qualifying index procedure, in accordance with the applicable guidelines on percutaneous coronary interventions and manufacturer's Instructions for Use. 3. Subject received at least one Orsiro stent during an index procedure occurring within 24 hours prior to informed consent, as assessed by the end time of procedure. If more than one stent was implanted during the index procedure, all stents were Orsiro stents. 4. Subject is eligible for dual antiplatelet therapy (DAPT) treatment with aspirin plus either clopidogrel, prasugrel, ticagrelor or ticlopidine. 5. Subject is willing to comply with study follow-up requirements. 6. Subject has provided written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site. Legally authorized representatives are not allowed to consent on a subject's behalf. Each target lesion/vessel must have met all of the following angiographic criteria from the index procedure for the subject to be eligible for the trial: 1. Subject has up to three target lesions in up to two separate target vessels (two target lesions in one vessel and one target lesion in a separate vessel). 2. Target lesion must be de novo or restenotic lesion in native coronary artery; restenotic lesion must have been treated with a standard PTCA only. 3. Target lesion must be in major coronary artery or branch (target vessel). 4. Target lesion must have angiographic evidence of ≥ 50% and \< 100% stenosis (by operator visual estimate). If the target lesion is \< 70% stenosed, there should be clinical evidence of ischemia. 5. Target vessel must have a Thrombolysis In Myocardial Infarction (TIMI) flow \> 1. 6. Target lesion must be ≤ 36 mm in length by operator visual estimate. 7. Target vessel must have a reference vessel diameter of 2.25-4.0 mm by operator visual estimate. 8. Target lesion must have been treated with a maximum of two overlapping stents.
Exclusion criteria
1. Subject had clinical symptoms and/or electrocardiogram (ECG) changes consistent with acute ST elevation MI (STEMI) within 72 hours prior to the index procedure. 2. Subject is pregnant and/or breastfeeding or intends to become pregnant during the duration of the study. 3. Subject has a known allergy to contrast medium that cannot be adequately pre-medicated, or any known allergy to thienopyridine, aspirin, both heparin and bivalirudin, L-605 cobalt-chromium (Co-Cr) alloy or one of its major elements (cobalt, chromium, tungsten and nickel), silicon carbide, PLLA, sirolimus. 4. Revascularization of any target vessel within 9 months prior to the index procedure or previous PCI of any non-target vessel within 30 days prior to the index procedure or any PCI planned within the next 1 year. 5. Presence of an untreated clinically significant stenosis post-procedure whether treatment is planned or not. 6. Planned surgery within 6 months of index procedure unless DAPT can be maintained throughout the peri-surgical period. 7. History of a stroke or transient ischemic attack (TIA) within 6 months prior to the index procedure. 8. Subject has documented LVEF \< 30% prior to consent. 9. Subject is dialysis-dependent. 10. Subject has impaired renal function (blood creatinine \> 2.5 mg/dL or 221 μmol/L prior to the index procedure). 11. Subject has leukopenia (i.e. \< 3,000 white blood cells/mm3), thrombocytopenia (i.e. \< 100,000 platelets/mm3) or thrombocytosis (i.e. \> 700,000 platelet/mm3). 12. Any significant concurrent medical diagnosis that would potentially impact DAPT effectiveness or increase thrombotic risk. 13. Subject is receiving chronic anticoagulation (e.g. coumadin, dabigatran, apixaban, rivaroxaban or any other agent). 14. Subject has life expectancy of \< 1 year. 15. Subject is participating in an investigational (medical device or drug) clinical study. Subjects may be concurrently enrolled in a post-market study, as long as the post-market study device, drug or protocol does not interfere with the follow-up requirements of this study or does not involve a drug that may confound the interpretation of any relevant clinical events of interest (e.g. investigational DAPT therapy). 16. In the investigator's opinion, subject will not be able to comply with the follow-up requirements. Subjects will be excluded from the trial if any of the target lesions/vessels met any of the following angiographic criteria during the index procedure: 1. Target lesion was located within or treated through a saphenous vein graft or arterial graft. 2. Target lesion was a restenotic lesion that was previously treated with a bare metal or drug-eluting stent (in-stent restenosis). 3. Target lesion had any of the following characteristics: 1. Lesion location is within the left main coronary artery, or within 3 mm of the origin of the left anterior descending (LAD) or left circumflex (LCX). 2. Involves a side branch of \> 2.0 mm in diameter. 4. Target vessel/lesion was excessively tortuous/angulated or is severely calcified, that would prevent complete inflation of an angioplasty balloon. This assessment should be based on visual estimation. 5. Target vessel had angiographic evidence of thrombus. 6. Target lesion was totally occluded (100% stenosis). 7. Target vessel was treated with brachytherapy any time prior to the index procedure.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Target Lesion Failure (TLF) at 12 Months Post-Index Procedure | 12-Months | TLF is defined as all cardiac death, target vessel Q-wave or non-Q-wave myocardial infarction (MI), or clinically driven target lesion revascularization (TLR). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All-cause Death | at Hospital Discharge an average of 1 day, at 1 Month, at 1 Year | — |
| Protocol-defined Any-vessel Myocardial Infarction | at Hospital Discharge an average of 1 day, at 1 Month, at 1 Year | — |
| Target Lesion Revascularization (TLR) | at Hospital Discharge an average of 1 day, at 1 Month, at 1 Year | — |
| Target Vessel Revascularization (TVR) | at Hospital Discharge an average of 1 day, at 1 Month, at 1 Year | — |
| Cardiac Death or Protocol-defined Any-vessel MI | at Hospital Discharge an average of 1 day, at 1 Month, at 1 Year | — |
| Target Lesion Failure (Cardiac Death, Protocol-defined Target Vessel MI, Clinically-driven TLR) | at Hospital Discharge an average of 1 day, at 1 Month, at 1 Year | — |
| Target Vessel Failure (Cardiac Death, Protocol-defined Target Vessel MI, Clinically-driven TVR) | at Hospital Discharge an average of 1 day, at 1 Month, at 1 Year | — |
| MACE (Death, Protocol-defined Any Vessel Q Wave or Non-Q Wave MI, Clinically-driven TLR | at Hospital Discharge an average of 1 day, at 1 Month, at 1 Year | — |
| Stent Thrombosis | at 24 Hours, at 1 Month, at 1 Year | — |
| Number of Lesions With Device Success | at Hospital Discharge an average of 1 day | Defined as attainment of \< 30% residual stenosis of the target lesion using the assigned study stent only. |
| Number of Lesions With Lesion Success | at Hospital Discharge an average of 1 day | Defined as attainment of \< 30% residual stenosis of the target lesion using any percutaneous method. |
| Number of Participants With Procedure Success | at Hospital Discharge an average of 1 day | Defined as attainment of \< 30% residual stenosis of the target lesion using the assigned study stent only without occurrence of in-hospital major adverse cardiac events (MACE; composite of all-cause death, Q-wave or non-Q-wave MI, and any clinically-driven TLR). |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDavid Kandzari, MD
Piedmont Heart Institute
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Orsiro Sirolimus Coronary Stent System Intervention with a Orsiro DES.
Orsiro DES: Orsiro is a device/drug combination product composed of two components, a device (coronary stent system including a cobalt chromium stent platform), and a drug product (a formulation of sirolimus) contained in a bioabsorbable polymer coating. | 556 |
| Total | 556 |
Baseline characteristics
| Characteristic | Orsiro Sirolimus Coronary Stent System |
|---|---|
| Age, Continuous | 65.2 years STANDARD_DEVIATION 10.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 31 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 513 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 12 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 9 Participants |
| Race (NIH/OMB) Black or African American | 51 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 43 Participants |
| Race (NIH/OMB) White | 452 Participants |
| Sex: Female, Male Female | 193 Participants |
| Sex: Female, Male Male | 363 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 6 / 556 |
| other Total, other adverse events | 58 / 556 |
| serious Total, serious adverse events | 154 / 556 |
Outcome results
Primary
Percentage of Participants With Target Lesion Failure (TLF) at 12 Months Post-Index Procedure
TLF is defined as all cardiac death, target vessel Q-wave or non-Q-wave myocardial infarction (MI), or clinically driven target lesion revascularization (TLR).
Time frame: 12-Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Orsiro Sirolimus Coronary Stent System | Percentage of Participants With Target Lesion Failure (TLF) at 12 Months Post-Index Procedure | 9 Participants |
Comparison: The primary endpoint was evaluated by performing an exact, binomial test comparing the rate of TLF for the Orsiro stent at 1 year to a performance goal of 6.9%, with Type I error (alpha) of 0.025 and power of 80%. The null hypothesis (Ho) was stated as: The TLF rate of the Orsiro stent at 1 year is greater than or equal to 6.9%. The alternative hypothesis (Ha) was stated as: The TLF rate of the Orsiro stent at 1 year is less than 6.9%.p-value: <0.0001Exact, binomial
Secondary
All-cause Death
Time frame: at Hospital Discharge an average of 1 day, at 1 Month, at 1 Year
Population: Analysis population for each outcome measure time frame is based on participants completing or experiencing an event at that time frame.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Orsiro Sirolimus Coronary Stent System | All-cause Death | Hospital Discharge | 1 Participants |
| Orsiro Sirolimus Coronary Stent System | All-cause Death | 1 Month | 2 Participants |
| Orsiro Sirolimus Coronary Stent System | All-cause Death | 1 Year | 6 Participants |
Secondary
Cardiac Death or Protocol-defined Any-vessel MI
Time frame: at Hospital Discharge an average of 1 day, at 1 Month, at 1 Year
Population: Analysis population for each outcome measure time frame is based on participants completing or experiencing an event at that time frame.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Orsiro Sirolimus Coronary Stent System | Cardiac Death or Protocol-defined Any-vessel MI | Hospital Discharge | 3 Participants |
| Orsiro Sirolimus Coronary Stent System | Cardiac Death or Protocol-defined Any-vessel MI | 1 Month | 4 Participants |
| Orsiro Sirolimus Coronary Stent System | Cardiac Death or Protocol-defined Any-vessel MI | 1 Year | 9 Participants |
Secondary
MACE (Death, Protocol-defined Any Vessel Q Wave or Non-Q Wave MI, Clinically-driven TLR
Time frame: at Hospital Discharge an average of 1 day, at 1 Month, at 1 Year
Population: Analysis population for each outcome measure time frame is based on participants completing or experiencing an event at that time frame.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Orsiro Sirolimus Coronary Stent System | MACE (Death, Protocol-defined Any Vessel Q Wave or Non-Q Wave MI, Clinically-driven TLR | Hospital Discharge MACE Total | 4 Participants |
| Orsiro Sirolimus Coronary Stent System | MACE (Death, Protocol-defined Any Vessel Q Wave or Non-Q Wave MI, Clinically-driven TLR | Hospital Discharge MACE Component: Death | 1 Participants |
| Orsiro Sirolimus Coronary Stent System | MACE (Death, Protocol-defined Any Vessel Q Wave or Non-Q Wave MI, Clinically-driven TLR | Hospital Discharge MACE Component: Protocol-defined Any-Vessel Q Wave or Non-Q Wave MI | 3 Participants |
| Orsiro Sirolimus Coronary Stent System | MACE (Death, Protocol-defined Any Vessel Q Wave or Non-Q Wave MI, Clinically-driven TLR | Hospital Discharge MACE Component: Clinically-driven TLR | 2 Participants |
| Orsiro Sirolimus Coronary Stent System | MACE (Death, Protocol-defined Any Vessel Q Wave or Non-Q Wave MI, Clinically-driven TLR | 1 Month MACE Total | 6 Participants |
| Orsiro Sirolimus Coronary Stent System | MACE (Death, Protocol-defined Any Vessel Q Wave or Non-Q Wave MI, Clinically-driven TLR | 1 Month MACE Component: Death | 2 Participants |
| Orsiro Sirolimus Coronary Stent System | MACE (Death, Protocol-defined Any Vessel Q Wave or Non-Q Wave MI, Clinically-driven TLR | 1 Month MACE Component: Protocol-defined Any-Vessel Q Wave or Non-Q Wave MI | 4 Participants |
| Orsiro Sirolimus Coronary Stent System | MACE (Death, Protocol-defined Any Vessel Q Wave or Non-Q Wave MI, Clinically-driven TLR | 1 Month MACE Component: Clinically-driven TLR | 2 Participants |
| Orsiro Sirolimus Coronary Stent System | MACE (Death, Protocol-defined Any Vessel Q Wave or Non-Q Wave MI, Clinically-driven TLR | 1 Year MACE Total | 17 Participants |
| Orsiro Sirolimus Coronary Stent System | MACE (Death, Protocol-defined Any Vessel Q Wave or Non-Q Wave MI, Clinically-driven TLR | 1 Year MACE Component: Death | 6 Participants |
| Orsiro Sirolimus Coronary Stent System | MACE (Death, Protocol-defined Any Vessel Q Wave or Non-Q Wave MI, Clinically-driven TLR | 1 Year MACE Component: Protocol-defined Any-Vessel Q Wave or Non-Q Wave MI | 9 Participants |
| Orsiro Sirolimus Coronary Stent System | MACE (Death, Protocol-defined Any Vessel Q Wave or Non-Q Wave MI, Clinically-driven TLR | 1 Year MACE Component: Clinically-driven TLR | 5 Participants |
Secondary
Number of Lesions With Device Success
Defined as attainment of \< 30% residual stenosis of the target lesion using the assigned study stent only.
Time frame: at Hospital Discharge an average of 1 day
Population: Device Success per lesion. Lesions that were not treated and lesions missing both site-reported and core lab-assessed percent residual stenosis were excluded from the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Orsiro Sirolimus Coronary Stent System | Number of Lesions With Device Success | 689 Lesions |
Secondary
Number of Lesions With Lesion Success
Defined as attainment of \< 30% residual stenosis of the target lesion using any percutaneous method.
Time frame: at Hospital Discharge an average of 1 day
Population: Lesion Success per lesion. Lesions that were not treated and lesions missing both site-reported and core lab-assessed percent residual stenosis were excluded from the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Orsiro Sirolimus Coronary Stent System | Number of Lesions With Lesion Success | 689 Lesions |
Secondary
Number of Participants With Procedure Success
Defined as attainment of \< 30% residual stenosis of the target lesion using the assigned study stent only without occurrence of in-hospital major adverse cardiac events (MACE; composite of all-cause death, Q-wave or non-Q-wave MI, and any clinically-driven TLR).
Time frame: at Hospital Discharge an average of 1 day
Population: Procedure success was analyzed per subject: for a subject to be considered a procedure success, all of the subject's target lesions had to be considered device success. Lesions that were not treated and lesions missing both site-reported and core lab-assessed percent residual stenosis were excluded from the analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Orsiro Sirolimus Coronary Stent System | Number of Participants With Procedure Success | 551 Participants |
Secondary
Protocol-defined Any-vessel Myocardial Infarction
Time frame: at Hospital Discharge an average of 1 day, at 1 Month, at 1 Year
Population: Analysis population for each outcome measure time frame is based on participants completing or experiencing an event at that time frame.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Orsiro Sirolimus Coronary Stent System | Protocol-defined Any-vessel Myocardial Infarction | Hospital Discharge | 3 Participants |
| Orsiro Sirolimus Coronary Stent System | Protocol-defined Any-vessel Myocardial Infarction | 1 Month | 4 Participants |
| Orsiro Sirolimus Coronary Stent System | Protocol-defined Any-vessel Myocardial Infarction | 1 Year | 9 Participants |
Secondary
Stent Thrombosis
Time frame: at 24 Hours, at 1 Month, at 1 Year
Population: Analysis population for each outcome measure time frame is based on participants completing or experiencing an event at that time frame.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Orsiro Sirolimus Coronary Stent System | Stent Thrombosis | Probable ARC-2 Stent Thrombosis Late (>30 days and <=1 year) | 0 Participants |
| Orsiro Sirolimus Coronary Stent System | Stent Thrombosis | Any ARC-2 Stent Thrombosis Acute (<=24 hours) | 1 Participants |
| Orsiro Sirolimus Coronary Stent System | Stent Thrombosis | Any ARC-2 Stent Thrombosis Sub-acute (>24 hours and <=30 days) | 0 Participants |
| Orsiro Sirolimus Coronary Stent System | Stent Thrombosis | Any ARC-2 Stent Thrombosis Late (>30 days and <=1 year) | 1 Participants |
| Orsiro Sirolimus Coronary Stent System | Stent Thrombosis | Definite ARC-2 Stent Thrombosis Acute (<=24 hours) | 1 Participants |
| Orsiro Sirolimus Coronary Stent System | Stent Thrombosis | Definite ARC-2 Stent Thrombosis Sub-acute (>24 hours and <=30 days) | 0 Participants |
| Orsiro Sirolimus Coronary Stent System | Stent Thrombosis | Definite ARC-2 Stent Thrombosis Late (>30 days and <=1 year) | 1 Participants |
| Orsiro Sirolimus Coronary Stent System | Stent Thrombosis | Probable ARC-2 Stent Thrombosis Acute (<=24 hours) | 0 Participants |
| Orsiro Sirolimus Coronary Stent System | Stent Thrombosis | Probable ARC-2 Stent Thrombosis Sub-acute (>24 hours and <=30 days) | 0 Participants |
Secondary
Target Lesion Failure (Cardiac Death, Protocol-defined Target Vessel MI, Clinically-driven TLR)
Time frame: at Hospital Discharge an average of 1 day, at 1 Month, at 1 Year
Population: Analysis population for each outcome measure time frame is based on participants completing or experiencing an event at that time frame.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Orsiro Sirolimus Coronary Stent System | Target Lesion Failure (Cardiac Death, Protocol-defined Target Vessel MI, Clinically-driven TLR) | Hospital Discharge TLF Total | 3 Participants |
| Orsiro Sirolimus Coronary Stent System | Target Lesion Failure (Cardiac Death, Protocol-defined Target Vessel MI, Clinically-driven TLR) | Hospital Discharge TLF Component: Cardiac Death | 0 Participants |
| Orsiro Sirolimus Coronary Stent System | Target Lesion Failure (Cardiac Death, Protocol-defined Target Vessel MI, Clinically-driven TLR) | Hospital Discharge TLF Component: Protocol-defined Target Vessel MI | 3 Participants |
| Orsiro Sirolimus Coronary Stent System | Target Lesion Failure (Cardiac Death, Protocol-defined Target Vessel MI, Clinically-driven TLR) | Hospital Discharge TLF Component: Clinically-driven TLR | 2 Participants |
| Orsiro Sirolimus Coronary Stent System | Target Lesion Failure (Cardiac Death, Protocol-defined Target Vessel MI, Clinically-driven TLR) | 1 Month TLF Total | 4 Participants |
| Orsiro Sirolimus Coronary Stent System | Target Lesion Failure (Cardiac Death, Protocol-defined Target Vessel MI, Clinically-driven TLR) | 1 Month TLF Component: Cardiac Death | 0 Participants |
| Orsiro Sirolimus Coronary Stent System | Target Lesion Failure (Cardiac Death, Protocol-defined Target Vessel MI, Clinically-driven TLR) | 1 Month TLF Component: Protocol-defined Target Vessel MI | 4 Participants |
| Orsiro Sirolimus Coronary Stent System | Target Lesion Failure (Cardiac Death, Protocol-defined Target Vessel MI, Clinically-driven TLR) | 1 Month TLF Component: Clinically-driven TLR | 2 Participants |
| Orsiro Sirolimus Coronary Stent System | Target Lesion Failure (Cardiac Death, Protocol-defined Target Vessel MI, Clinically-driven TLR) | 1 Year TLF Total | 9 Participants |
| Orsiro Sirolimus Coronary Stent System | Target Lesion Failure (Cardiac Death, Protocol-defined Target Vessel MI, Clinically-driven TLR) | 1 Year TLF Component: Cardiac Death | 0 Participants |
| Orsiro Sirolimus Coronary Stent System | Target Lesion Failure (Cardiac Death, Protocol-defined Target Vessel MI, Clinically-driven TLR) | 1 Year TLF Component: Protocol-defined Target Vessel MI | 7 Participants |
| Orsiro Sirolimus Coronary Stent System | Target Lesion Failure (Cardiac Death, Protocol-defined Target Vessel MI, Clinically-driven TLR) | 1 Year TLF Component: Clinically-driven TLR | 5 Participants |
Secondary
Target Lesion Revascularization (TLR)
Time frame: at Hospital Discharge an average of 1 day, at 1 Month, at 1 Year
Population: Analysis population for each outcome measure time frame is based on participants completing or experiencing an event at that time frame.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Orsiro Sirolimus Coronary Stent System | Target Lesion Revascularization (TLR) | Hospital Discharge | 2 Participants |
| Orsiro Sirolimus Coronary Stent System | Target Lesion Revascularization (TLR) | 1 Month | 3 Participants |
| Orsiro Sirolimus Coronary Stent System | Target Lesion Revascularization (TLR) | 1 Year | 8 Participants |
Secondary
Target Vessel Failure (Cardiac Death, Protocol-defined Target Vessel MI, Clinically-driven TVR)
Time frame: at Hospital Discharge an average of 1 day, at 1 Month, at 1 Year
Population: Analysis population for each outcome measure time frame is based on participants completing or experiencing an event at that time frame.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Orsiro Sirolimus Coronary Stent System | Target Vessel Failure (Cardiac Death, Protocol-defined Target Vessel MI, Clinically-driven TVR) | Hospital Discharge TVF Total | 3 Participants |
| Orsiro Sirolimus Coronary Stent System | Target Vessel Failure (Cardiac Death, Protocol-defined Target Vessel MI, Clinically-driven TVR) | Hospital Discharge TVF Component: Cardiac Death | 0 Participants |
| Orsiro Sirolimus Coronary Stent System | Target Vessel Failure (Cardiac Death, Protocol-defined Target Vessel MI, Clinically-driven TVR) | Hospital Discharge TVF Component: Protocol-defined Target Vessel MI | 3 Participants |
| Orsiro Sirolimus Coronary Stent System | Target Vessel Failure (Cardiac Death, Protocol-defined Target Vessel MI, Clinically-driven TVR) | Hospital Discharge TVF Component: Clinically-driven TVR | 2 Participants |
| Orsiro Sirolimus Coronary Stent System | Target Vessel Failure (Cardiac Death, Protocol-defined Target Vessel MI, Clinically-driven TVR) | 1 Month TVF Total | 4 Participants |
| Orsiro Sirolimus Coronary Stent System | Target Vessel Failure (Cardiac Death, Protocol-defined Target Vessel MI, Clinically-driven TVR) | 1 Month TVF Component: Cardiac Death | 0 Participants |
| Orsiro Sirolimus Coronary Stent System | Target Vessel Failure (Cardiac Death, Protocol-defined Target Vessel MI, Clinically-driven TVR) | 1 Month TVF Component: Protocol-defined Target Vessel MI | 4 Participants |
| Orsiro Sirolimus Coronary Stent System | Target Vessel Failure (Cardiac Death, Protocol-defined Target Vessel MI, Clinically-driven TVR) | 1 Month TVF Component: Clinically-driven TVR | 2 Participants |
| Orsiro Sirolimus Coronary Stent System | Target Vessel Failure (Cardiac Death, Protocol-defined Target Vessel MI, Clinically-driven TVR) | 1 Year TVF Total | 14 Participants |
| Orsiro Sirolimus Coronary Stent System | Target Vessel Failure (Cardiac Death, Protocol-defined Target Vessel MI, Clinically-driven TVR) | 1 Year TVF Component: Cardiac Death | 0 Participants |
| Orsiro Sirolimus Coronary Stent System | Target Vessel Failure (Cardiac Death, Protocol-defined Target Vessel MI, Clinically-driven TVR) | 1 Year TVF Component: Protocol-defined Target Vessel MI | 7 Participants |
| Orsiro Sirolimus Coronary Stent System | Target Vessel Failure (Cardiac Death, Protocol-defined Target Vessel MI, Clinically-driven TVR) | 1 Year TVF Component: Clinically-driven TVR | 12 Participants |
Secondary
Target Vessel Revascularization (TVR)
Time frame: at Hospital Discharge an average of 1 day, at 1 Month, at 1 Year
Population: Analysis population for each outcome measure time frame is based on participants completing or experiencing an event at that time frame.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Orsiro Sirolimus Coronary Stent System | Target Vessel Revascularization (TVR) | 1 Year | 15 Participants |
| Orsiro Sirolimus Coronary Stent System | Target Vessel Revascularization (TVR) | Hospital Discharge | 2 Participants |
| Orsiro Sirolimus Coronary Stent System | Target Vessel Revascularization (TVR) | 1 Month | 3 Participants |