Series III Run-In Trial

Phase 4

Conditions: Health Condition 1: null- Coronary Artery Disease

Registration Number: CTRI/2009/091/000347

Lead Sponsor: Sahajanand Medical Technologies Pvt Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Other (Terminated)

Sex: Not specified

Target Recruitment: 360

Inclusion Criteria

1. Age greater than or equal to 18 years.
2. Eligible for percutaneous coronary intervention (PCI)
3. Acceptable candidate for CABG
4. Clinical evidence of ischemic heart disease and/or a positive territorial functional study. Documented stable angina pectoris ((Canadian Cardiovascular Society (CCS) Classification 1, 2, 3 or 4) or unstable angina pectoris with documented ischemia (Braunwald Class IB-C, IIB-C or IIIB-C), or documented silent ischemia.
5. The target lesion is a single de novo coronary artery lesion with greater than or equal to 50% and < 100% stenosis in one of the major epicardial territories (LAD, LCX or RCA). A second target lesion in another major epicardial vessel could be treated and this second lesion should fit with the inclusion/exclusion criteria and will receive the same type of stent.
6. The target lesion must be covered by one study stent, preferably with a margin of 3 mm on each side of the lesion.
7. The target lesion must be less than or equal to 22 mm in length by visual estimate.
8. The target reference vessel diameter must be greater or equal to 2.5 mm and less or equal to 3.5 mm.
9. Patient or patient's legal representative has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board/Ethics Committee of the clinical site.

Exclusion Criteria

1. Female of childbearing potential
2. Documented left ventricular ejection fraction (LVEF) less than or equal to 30%
3. Evidence of an acute Q-wave or non-Q-wave myocardial infarction within 72 hours preceding the index procedure
4. Known allergies to the following: aspirin, clopidogrel bisulfate (Plavix®, Ceruvin) or ticlopidine (Ticlid®), heparin, sirolimus, everolimus, stainless steel, cobalt, chromium, contrast agent (that cannot be adequately pre-medicated)
5. A platelet count <100,000 cells/mm3 or >700,000 cells/mm3 or a WBC <3,000 cells/mm3
6. Acute or chronic renal dysfunction (creatinine >2.0mg/dl or >150µmol/L)
7. Total occlusion (TIMI 0) or TIMI 1
8. Target vessel has evidence of thrombus
9. Target vessel is excessively tortuous which makes it unsuitable for proper stent delivery and deployment
10. Previous bare metal stenting (less than 1 year) anywhere within the target vessel
11. Previous drug-eluting stenting anywhere within any epicardial vessel
12. The target lesion requires treatment with a device other than PTCA prior to stent placement (e.g. but not limited to, directional coronary atherectomy, excimer laser, rotational atherectomy, etc.)
13. Significant (>50%) stenosis proximal or distal to the target lesion that might require revascularization or impede run-off
14. Heavily calcified lesion and/or calcified lesion which cannot be successfully predilated
15. Target lesion is located in or supplied by an arterial or venous bypass graft
16. Ostial target lesion
17. Target lesion involves a side branch >2.0mm in diameter with an ostial disease
18. Patient is currently participating in an investigational drug or device study, including its follow-up period
19. Within 30 days prior to procedure, patient has undergone a previous coronary interventional procedure of any kind
20. Within 60 days post-procedure, patient requires planned interventional treatment of any non-target vessel. Planned intervention of the target vessel after the index procedure is not allowed.
21. Stroke or transient ischemic attack within the prior 6 months
22. Unprotected Left Main (LM) coronary artery disease (stenosis >50%)
23. In the investigator's opinion, patient has a co-morbid condition(s) that could limit the patient's ability to participate in the study, compliance with follow-up requirements or impact the scientific integrity of the study
24. Planned surgery within 6 months after the index procedure
25. Life expectancy less than 1 year