To evaluate safety and performance of the BioMimeâ?¢- Sirolimus Eluting Coronary Stent System in the treatment of patients during a pre-defined period.
Phase 4
Completed
- Conditions
- Health Condition 1: I259- Chronic ischemic heart disease, unspecified
- Registration Number
- CTRI/2017/10/009968
- Lead Sponsor
- Meril Life Sciences Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 1161
Inclusion Criteria
1. Patient is 18 Year old.
2. Patients who have been implanted with BioMime Sirolimus Eluting Coronary
Stent System between January-2010 to February-2011.
3. The patient and/or his legal representative have provided a hospital written informed
consent.
Exclusion Criteria
1. Patients who have not been implanted with BioMime• â?? Sirolimus Eluting Coronary
Stent System.
2. Patients who have been implanted with BioMime• â?? Sirolimus Eluting Coronary
Stent System before and after January-2010 to February-2011
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.month clinical/telephonic follow-up and 6 months clinical/ telephonic follow-up. <br/ ><br>The secondary endpoint of this study is to evaluate the MACE events at 12 months clinical/ <br/ ><br>telephonic follow-up. <br/ ><br>For this study Major Adverse Cardiac Event (MACE) is defined as a composite of: <br/ ><br>1. Death <br/ ><br>2. Myocardial Infarction (MI) <br/ ><br>3. Coronary Artery Bypass Graft (CABG) surgery <br/ ><br>4. Target Lesion Revascularisation (TLR) <br/ ><br>5. Target Vessel Revascularisation (TVR) and <br/ ><br>6. Stent Thrombosis (ST)Timepoint: 1 month, 6 months and 12 months clinical/telephonic follow-up data will be recorded in a pre-approved Case Report Form, and a safety analysis report will be prepared based on the above recorded parameters.
- Secondary Outcome Measures
Name Time Method The secondary endpoint of this study is to evaluate the MACE events at 12 months clinical/ <br/ ><br>telephonic follow-up.Timepoint: The secondary endpoint of this study is to evaluate the MACE events at 12 months clinical/ <br/ ><br>telephonic follow-up.