Investigator initiated retrospective observational study to determine safety and performance of Neohexa® Rapamycine(Sirolimus)-Eluting Coronary Stent System (SES) in all-comerpatients with coronary artery disease (CAD) in one year follow-upperiod.
- Conditions
- Health Condition 1: I251- Atherosclerotic heart disease of native coronary arteryHealth Condition 2: null- coronary artery disease (CAD)
- Registration Number
- CTRI/2018/03/012522
- Lead Sponsor
- Sahajanand Laser Technology Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 129
1. Males and Females more than 18 years of age.
2. Subjects who had signed the Hospital consent form.
3. The subjects who have been treated with PCI and implantated with Neohexa Drug Eluting Stent as a part of their treatment of Coronary Artery Disease, without any further indication for Emergent Coronary Artery Bypass Graft Surgery.
1.Subjects who were not eligible for a PCI procedure. Or who were candidates for Urgent or planned elective Coronary Artery Bypass Surgery.
2. Subjects who are treated with stents other than Neohexa stent.
3. Subjects who are known sensitive to Cobalt Chromium alloy,PLLA Polymer, Sirolimus and its Analogues, Aspirin, Clopidogrel and analogues, and Contrast media.
4. Pregnant/lactating women during Index procedure. However,if pregnancy occurs during followâ??ups, the subject will not be excluded.
5. Subjects with more than Grade III Renal Insufficiency as indicated by Creatinine > 160 mcmol/L.
6. Subjects with short life expectancy less than the trial duration of 1 years (including patients with cancer, HIV/AIDS),documented LVEF <30%, history of Cardiac Failure, Structural
heart disease, Myocardiopathies, Arrhythmia or other Comorbid conditions.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate major adverse cardiac event (MACE) at 6 month <br/ ><br>defined as the composite of cardiac death, myocardial infarction (MI) <br/ ><br>and target lesion revascularization (TLR).Timepoint: 6 Month
- Secondary Outcome Measures
Name Time Method 1. Target Lesion Revascularization at 1,6 and 12 months. <br/ ><br>2. Major Adverse Cardiac Events at 1,6 and 12 months. <br/ ><br>3. Frequency of Stent Thrombosis <br/ ><br>a. Acute (0â??48 hours after stent implant) <br/ ><br>b. Late (1 month to 1 year after stent implant) <br/ ><br>c. Very Late (Beyond 1 year after stent Implant) <br/ ><br>d. By ARC definitions: Viz. Definite, Probable and Possible, at all <br/ ><br>follow up visits.Timepoint: 1month 6month 12, month