Health Condition 1: null- Coronary Artery Disease
Conditions
Interventions
Intervention1: The Orsiro Sirolimus-Eluting Coronary Stent System: The intervention agent used in this study is coronary stent ?The Orsiro Sirolimus-Eluting Coronary Stent System containing PRO-Kine
Sponsors
BIOTRONIK AG
Max Neeman Medical International Limited
Eligibility
Inclusion criteria
Inclusion criteria: Patient has provided a written informed consent 2. Patient is ≥ 18 and ≤80 years old 3. Single de novo lesion with ≥50% and 100% stenosis in up to 2 coronary arteries 4. Patient, target vessel(s) and lesion(s) are eligible for PCI with the Orsiro stent 5. The target lesion length is ≤26 mm (assessed either visually or by online QCA) and can be covered by one clinical investigation stent 6. The target reference vessel diameter is ≥2.0 mm and ≤ 4.0 mm (assessed either visually or by online QCA) 7. Target vessel(s) with TIMI flow ≥2 8. Patient is an acceptable candidate for CABG 9. Clinical evidence of stable or unstable angina pectoris or documented silent ischemia 10. Eligible for DAPT treatment with ASA plus either, Clopidogrel, Prasugrel, Ticlopidine or Ticagrelor
Exclusion criteria
Exclusion criteria: Pregnant and/or breast-feeding females or females who intend to become pregnant during the time of the clinical investigation 2. Evidence of myocardial infarction within 72 hours prior to the index procedure 3. Patients with CKMB and/or Troponin levels exceeding the normal range within 24 hours prior to the procedure 4. Unprotected Left Main coronary artery disease (stenosis 50%) 5. Three-vessel coronary artery disease at time of procedure 6. Thrombus in target vessel 7. Planned interventional treatment of any non-target vessel within 30 days post-procedure. 8. Planned intervention of the target vessels after the index 9. Ostial target lesion (within 5.0mm of vessel origin) 10. Target lesion involves a side branch 2.0mm in diameter 11. Documented left ventricular ejection fraction (LVEF) ≤30% 12. Heavily calcified lesion which cannot be successfully pre-dilated; 13. Target lesion is located in or supplied by an arterial or venous bypass graft 14. The target lesion requires treatment with a device other than the pre-dilatation balloon prior to stent placement (including but not limited to, directional coronary atherectomy, excimer laser, rotational atherectomy, cutting balloon etc.) 15. Known allergies to: Acetylsalicylic Acid (ASA), Heparin, Contrast medium, Sirolimus or drugs similar to Sirolimus (i.e. Everolimus, ABT 578, Biolimus,Tacrolimus); CoCr, PLLA, Silicon Carbide 16. Impaired renal function (serum creatinine 2.5mg/dl or 221mol/l, determined within 72 hours prior to intervention) 17. Patient is receiving oral or intravenous immunosuppressive therapy (e.g., inhaled steroids are not excluded) or has known life-limiting immunosuppressive or autoimmune disease (e.g., human immunodeficiency virus, systemic lupus erythematosus, but not including diabetes mellitus) 18. Proximal or distal to the target lesion located stenosis that might require future revascularization or impede run off 19. Life expectancy less than 1 year. 20. Planned surgery or dental surgical procedure within 12 months after index procedure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| In-stent late lumen lossTimepoint: 9 months post procedure. | — |
Secondary
| Measure | Time frame |
|---|---|
| All cardiac deathsTimepoint: Through out the study period;All Serious Adverse Device Effects (SADEs)Timepoint: Through out the study period;All target vessel MITimepoint: Through out the study period;Clinically driven target lesion revascularization (TLR)Timepoint: At 1, 6, and 12 months post-procedure;Clinically driven target vessel revascularization (TVR)Timepoint: At 1, 6, and 12 months post-procedure;Definite Stent thrombosisTimepoint: 1, 6 and 12 months post-procedure;In-segment late lumen loss (LLL)Timepoint: 9 months post-procedure;In-stent and in-segment (proximal and distal) minimum lumen diameter (MLD) Timepoint: at 9 months post-procedure through out the study period.;In-stent and in-segment binary restenosis rate angiographically assessed (â?¥ 50% diameter stenosis) Timepoint: at 9 months post procedure;In-stent and in-segment percent diameter stenosis (% DS)Timepoint: Through out the study period.;Target Lesion Failure (TLF), composite of Cardiac death, Target vessel Q-wave or non-Q wave Myocardial Infarction (MI) (i.e., Q-wave MI that cannot be attributed to a non-target vessel), Clinically driven Target Lesion Revascularization (TLR), emergent Coronary Artery Bypass Grafting (CABG) Timepoint: Through out the study period;Target Vessel Failure (TVF), composite of Cardiac Death, MI and clinically driven TVRTimepoint: Through out the study period | — |
Countries
India
Contacts
Public ContactDr Shariq Anwar
Max Neeman International
Outcome results
None listed