Clinical trial NCT00936780: Infinnium-Core™ Registry for the Treatment of Patients With De Novo Coronary Lesions
Official title: Safety and Efficacy of the Infinnium-Core™ Paclitaxel-Eluting Coronary Stent System for the Treatment of Patients With De Novo Coronary Lesions
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Coronary Artery Disease
Keywords: Coronary Artery Disease
Restenosis
Stent thrombosis
Coronary stents
Angioplasty
Drug Eluting Stents (DES)
Lead sponsor: Sahajanand Medical Technologies Limited
Sponsor class: INDUSTRY
First posted: 2009-07-10
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 include all statistically pre assigned 20% patients and all patients who have repeat angiography due to complication. The diabetic patients will be specified as a high risk subset in this study.

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 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 ≥ 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 ≤ 37 mm in length by visual estimate.
8. The target reference vessel diameter must be ≥ 2.5 mm and ≤ 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 notified / 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) ≤ 25%.
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, paclitaxel, 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 \> 2.0 mg/dl or \> 150 µmol/L).
7. Target vessel has evidence of thrombus.
8. Target vessel is excessively tortuous which makes it unsuitable for proper stent delivery and deployment.
9. Previous bare metal stenting (less than 1 year) anywhere within the target vessel.
10. Previous drug-eluting stenting anywhere within any epicardial vessel
11. 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.)
12. Significant (\> 50%) stenosis proximal or distal to the target lesion that might require revascularization or impede run-off.
13. Heavily calcified lesion and/or calcified lesion which cannot be successfully predilated.
14. Target lesion is located in or supplied by an arterial or venous bypass graft.
15. Ostial target lesion.
16. Patient is currently participating in an investigational drug or device study, including its follow-up period.
17. Within 30 days prior to procedure, patient has undergone a previous coronary interventional procedure of any kind.
18. 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.
19. CVA within previous 6 months.
20. Unprotected Left Main (LM) coronary artery disease (stenosis \> 50%).
21. 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.
22. Planned surgery within 6 months after the index procedure.
23. Life expectancy less than 1 year.

Primary outcomes:
measure: Major Adverse Cardiac Events (MACE)
timeFrame: 30 days and 9 month
Secondary outcomes:
measure: ANGIOGRAPHIC
timeFrame: 12 months
Other outcomes:
Locations:
city: Vadodara
country: India
facility: Bankers Heart Institute
state: Gujarat
city: Vadodara
country: India
facility: Baroda Heart Institute & Research Center
state: Gujarat
city: Indore.
country: India
facility: CHL Apollo Hospitals,
state: Madhya Pradesh.
city: Indore
country: India
facility: CHL Apollo Hospitals
state: Madhya Pradesh
city: Nagpur
country: India
facility: Government Medical College & Super Speciality Hospital
state: Maharashtra
city: Nagpur
country: India
facility: Arneja Heart Institute
state: Maharashtra
city: Coimbatore
country: India
facility: Sri Ramakrishna Heart Foundation & Research Centre
state: Tamilnadu
Study officials:
References: