Retrospective Clinical Investigation of Coronary Stents
- Conditions
- Health Condition 1: O- Medical and Surgical
- Registration Number
- CTRI/2022/02/040336
- Lead Sponsor
- Multimedics LLP
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Adult
Subjects with ischemic heart disease due to coronary artery lesion
Subjects implanted with Sirolimus Eluting Coronary Stent from the manufacturer via Percutaneous Transluminal Coronary Angioplasty (PTCA)
-Subjects expect in those with known allergies
-Subjects who are indicated for coronary bypass surgery.
-Subjects who exhibit angiographic evidence of existing thrombus.
-Subjects allergic to L605 Chromium cobalt.
-Subjects with a contradiction for anti-platelet / anti-coagulant therapy, this includes patients who have had major surgery, an obstetrical delivery organ biopsy, or puncture of a non- compressible vessel within 14 day of this procedure.
-Subjects with a history of gastrointestinal bleeding, recent C.V.A., diabetic hemorrhagic retinopathy, or any condition compromised by prolonged anti-coagulant.
-Subjects who have experienced a recent (less than 1 week) acute myocardial infarction.
-Subjects with diffuse disease, defined as long segments of abnormal vessel without interposed normal vessel.
-Subjects who have transplants.
-Subjects who got implanted with any other manufacturer Sirolimus Eluting Coronary Stent System
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method