Status:
TERMINATED
Infinnium-Core™ Registry for the Treatment of Patients With De Novo Coronary Lesions
Lead Sponsor:
Sahajanand Medical Technologies Limited
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The primary objective of Infinnium-Core™ Registry is to assess the safety and efficacy of the Infinnium-Core™ Paclitaxel Eluting Coronary Stent System in de novo Coronary Lesions.
Detailed Description
Infinnium-Core™ Registry is a multi-centric, prospective study. Approximately 150 patients will be enrolled in the study. Patients will be followed for two years post-procedure. Data analysis will in...
Eligibility Criteria
Inclusion
- Age ≥ 18 years.
- Eligible for percutaneous coronary intervention (PCI).
- Acceptable candidate for CABG.
- 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.
- The target lesion is a single de novo coronary artery lesion with ≥ 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.
- The target lesion must be covered by one study stent, preferably with a margin of 3 mm on each side of the lesion.
- The target lesion must be ≤ 37 mm in length by visual estimate.
- The target reference vessel diameter must be ≥ 2.5 mm and ≤ 3.5 mm.
- 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 notified / approved by the Institutional Review Board/Ethics Committee of the clinical site.
Exclusion
- Female of childbearing potential.
- Documented left ventricular ejection fraction (LVEF) ≤ 25%.
- Evidence of an acute Q-wave or non-Q-wave myocardial infarction within 72 hours preceding the index procedure.
- Known allergies to the following: aspirin, clopidogrel bisulfate (Plavix®, Ceruvin) or ticlopidine (Ticlid®), heparin, paclitaxel, cobalt, chromium, contrast agent (that cannot be adequately pre-medicated).
- A platelet count \<100,000 cells/mm3 or \> 700,000 cells/mm3 or a WBC \< 3,000 cells/mm3.
- Acute or chronic renal dysfunction (creatinine \> 2.0 mg/dl or \> 150 µmol/L).
- Target vessel has evidence of thrombus.
- Target vessel is excessively tortuous which makes it unsuitable for proper stent delivery and deployment.
- Previous bare metal stenting (less than 1 year) anywhere within the target vessel.
- Previous drug-eluting stenting anywhere within any epicardial vessel
- 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.)
- Significant (\> 50%) stenosis proximal or distal to the target lesion that might require revascularization or impede run-off.
- Heavily calcified lesion and/or calcified lesion which cannot be successfully predilated.
- Target lesion is located in or supplied by an arterial or venous bypass graft.
- Ostial target lesion.
- Patient is currently participating in an investigational drug or device study, including its follow-up period.
- Within 30 days prior to procedure, patient has undergone a previous coronary interventional procedure of any kind.
- 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.
- CVA within previous 6 months.
- Unprotected Left Main (LM) coronary artery disease (stenosis \> 50%).
- 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.
- Planned surgery within 6 months after the index procedure.
- Life expectancy less than 1 year.
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT00936780
Start Date
July 1 2008
End Date
March 1 2011
Last Update
August 23 2012
Active Locations (7)
Enter a location and click search to find clinical trials sorted by distance.
1
Bankers Heart Institute
Vadodara, Gujarat, India, 390 015
2
Baroda Heart Institute & Research Center
Vadodara, Gujarat, India, 390007
3
CHL Apollo Hospitals,
Indore, Madhya Pradesh, India, 452008
4
CHL Apollo Hospitals
Indore, Madhya Pradesh, India, 452008