Infinnium-Core™ Registry for the Treatment of Patients With De Novo Coronary Lesions
NCT ID: NCT00936780
Last Updated: 2012-08-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE4
67 participants
INTERVENTIONAL
2008-07-31
2011-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Infinnium-Core™ Paclitaxel eluting Coronary Stent
Infinnium-Core™ Paclitaxel eluting Coronary Stent
Infinnium-Core™ Coronary Stent System consisting of the Coronnium® coronary stent (CE approved) having Biodegradable Polymeric Matrix on a Co-Cr alloy Platform. Drug concentration is 1.36 µg/mm2.
Interventions
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Infinnium-Core™ Paclitaxel eluting Coronary Stent
Infinnium-Core™ Coronary Stent System consisting of the Coronnium® coronary stent (CE approved) having Biodegradable Polymeric Matrix on a Co-Cr alloy Platform. Drug concentration is 1.36 µg/mm2.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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.
Exclusion Criteria
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.
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.
18 Years
ALL
No
Sponsors
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Sahajanand Medical Technologies Limited
INDUSTRY
Responsible Party
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Locations
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Bankers Heart Institute
Vadodara, Gujarat, India
Baroda Heart Institute & Research Center
Vadodara, Gujarat, India
CHL Apollo Hospitals,
Indore, Madhya Pradesh, India
CHL Apollo Hospitals
Indore, Madhya Pradesh, India
Government Medical College & Super Speciality Hospital
Nagpur, Maharashtra, India
Arneja Heart Institute
Nagpur, Maharashtra, India
Sri Ramakrishna Heart Foundation & Research Centre
Coimbatore, Tamil Nadu, India
Countries
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Other Identifiers
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IC001: V1.1
Identifier Type: -
Identifier Source: org_study_id