Coronary Artery Disease
Conditions
Keywords
Coronary Artery Disease, Restenosis, Stent thrombosis, Coronary stents, Angioplasty, Drug Eluting Stents (DES)
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.
Interventions
DEVICEInfinnium-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.
Sponsors
Sahajanand Medical Technologies Limited
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major Adverse Cardiac Events (MACE) | 30 days and 9 month |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ANGIOGRAPHIC | 12 months | In Angiographic outcome measures the Minimal lumen diameter (MLD), % diameter stenosis, In-Stent and In-segment late loss, Proximal late loss, Distal late loss and Binary restenosis rate |
Countries
India
Outcome results
None listed