CTRI/2012/01/002393
Completed
Phase 4
A prospective, multicenter, post marketing surveillance study to evaluate the safety and effectiveness of the Superia-Sirolimus Eluting Coronary Stent System (SSECSS) implanted during routine clinical practice in India. - Superia Study
Innvolution Med System0 sites200 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Innvolution Med System
- Enrollment
- 200
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •GENERAL INCLUSION CRITERIA:
- •1\.Patient with age \> 18 years
- •2\.Patient who are suitable for implantation of one or more Superia\-Sirolimus Eluting Coronary Stent System in one or more native artery target lesions
- •3\. Patient agrees to participate in the study by signing the EC approved informed consent form.
- •4\. Patient with indication,lesion length and target lesion vessel diameter according to the Indications and Instructions for Use given with every Superia\-Sirolimus Eluting Coronary Stent System.
- •5\. The patient who fully agrees and are able to cooperate with registry procedures and required follow up.
- •6\. Patient must agree not to participate in any other clinical study for a period of 2 years following the index procedure.
- •ANGIOGRAPHIC INCLUSION CRITERIA:
- •1\.Target lesion must be located in native coronary artery with estimated diameter between 2\.5 to 3\.5 mm by visual estimation
- •2\.Treatment of two de novo lesions, each located in a separate native epicardial vessel.
Exclusion Criteria
- •GENERAL EXCLUSION CRITERIA:
- •1\. Patient with known diagnosis of acute myocardial infarction (AMI) preceding the index procedure (CK\-MB 2 times of upper limit of normal)and CK and CK\-MB not have returned to the upper limit of normal at the time of procedure
- •2\. Patient currently experiencing clinical symptoms consistent with AMI
- •3\. Patient with current unstable angina
- •4\. Patient with known left ventricular ejection fraction (LVEF) of less than 30%
- •5\. Patient with heart transplant or any other organ transplant or in waiting list of any organ transplant
- •6\. Patients with Acute Coronary Syndrome
- •7\. Female patients with known pregnancy or who are lactating
- •8\. Patients with known hypersensitivity or allergies to aspirin, heparin, clopidogrel, ticlopidine, Sirolimus or similar drugs, or any other analogue or derivative, cobalt, chromium, nickel, molybdenum or contrast media.
- •9\. Patients in whom anti\-platelet and/or anticoagulation therapy is contraindicated.
Outcomes
Primary Outcomes
Not specified
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