To Evaluate Safety and Performance of the BioMimeTM -Sirolimus Eluting Coronary Stent system for the treatment of patients with coronary artery lesions
- Conditions
- Health Condition 1: I251- Atherosclerotic heart disease of native coronary artery
- Registration Number
- CTRI/2016/11/007475
- Lead Sponsor
- Meril Life Sciences India Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
1. Patient is >18 years of age.
2. Patient is an acceptable candidate for PTCA, stenting, or emergent CABG
3. Patient has clinical evidence of ischemic heart disease or a positive functional
study.
4. Patient with his or her treating physician agree that the patient will comply with
all the required post-Procedure follow up
5. TIMI (Thrombolysis In Myocardial Infarction) Flow grade 2
6. Target Lesion(s) present with greater than or equal to 50% and <100% stenosis, in one vessel.
7. Target Lesion is de novo
8. A maximum of one (01) target lesion requires treatment
9. For a single lesion, a cumulative lesion length of up to 19mm is to be treated
10. Reference vessel diameter of target lesion(s) must be greater than or equal to 2.5mm and less than or equal to 3.5mm, by
visual estimate.
11. Patient or the patientâ??s legal representative has been informed of the nature of the
study and agrees to its provisions and has provided written informed consent as
approved by the Institutional Review Board/ Ethics Committee of the respective
clinical site.
1. Left ventricular ejection fraction (LVEF) of less than or equal to 30%
2. Patient has evidence of an acute myocardial Infarction whose onset began within
48 hours of the intended treatment (defined as Creatinine Kinase (CK) >2x the
upper limit of normal and CK-MB elevated) or CK or CK-MB remain elevated at
the time of treatment
3. History of CVA or TIA within the last 3 months
4. Patient has active infection.
5. Concurrent medical conditions with a life expectancy of less than 12 months.
6. Clinically relevant contraindication to aspirin, heparin, clopidogrel bisulphate
including thrombocytopenia, neutropenia, or leukopenia.
7. Active peptic ulcer or upper gastrointestinal bleeding.
8. Current participation in an investigational drug or device trial that has not
completed its primary end point follow-up period.
9. Pregnancy or woman of childbearing potential who, in the opinion of the
investigator, does not take adequate measures to prevent conception.
10. Known hypersensitivity or contraindication to cobalt, chromium, or nickel.
11. Known sensitivity to contrast dye that, in the opinion of the investigator, cannot
be adequately pre-medicated.
12. History of an allergic reaction or significant sensitivity to drugs such as mTOR or
any of its derivatives in the limus family of drugs.
13. Platelet count <100,000 cells/mm³ or >700,000 cells/mm³ or known
coagulopathy.
14. Serum creatinine >2.0 mg/dL or >180umol/L, renal failure, or liver disease.
15. The planned treatment requires a device (including non study drug-eluting stent)
or procedure other than PTCA (eg, directional coronary atherectomy, excimer
laser, rotational atherectomy, thrombectomy)
16. Previous brachytherapy anywhere in the target vessel
17. History of heart, liver, lung and kidney transplant.
18. Recipient of a Heart Transplant.
19. Target Vessel has evidence of thrombus or is excessively tortuous (2 bends >than
90° to reach the target lesion)
20. Evidence of unprotected left main coronary artery disease (an obstruction of
50% in the left main coronary artery).
21. Is the patient in Cardiogenic Shock?
22. Is it a Saphenous Vein Graft Intervention?
23. PCI during or within 48 hours of Acute Myocardial Infarction?
24. Significant stenosis ( >50%) proximal or distal to the target lesion that might
require revascularization or impede runoff.
25. Prior CABG Surgery to Target Vessel.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. In-Stent luminal loss assessed by quantitative coronary angiography (QCA) at 8 Month follows up. <br/ ><br>2. Percentage of In-Stent Volume obstruction measured by IVUS at 8 Month follows upTimepoint: 1,8, 12, 24 Month follows up. <br/ ><br>
- Secondary Outcome Measures
Name Time Method Occurrence of Major Adverse Cardiac Events (MACE) defined as cardiac death, nonfatal <br/ ><br>acute myocardial infarction, and need for repeat target-lesion revascularization (by <br/ ><br>cardiac bypass graft or repeat percutaneous coronary intervention up to 24 months of <br/ ><br>follow-up. <br/ ><br>â?¢ Angiographic binary restenosis at 8 months angiographic follow upTimepoint: 1,8, 12, 24 Month follows up