Health Condition 1: null- Patients with Coronaty Artery Disease
Conditions
Interventions
Intervention1: MAGIC TOUCH sirolimus drug coated Balloon: Ammazonia CroCO Bare Metal Stent and post dilatation with MAGIC TOUCH sirolimus drug coated balloon
Control Intervention1: Plain PTCA Balloon:
Sponsors
Concept Medical Research Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: General Inclusion Criteria 1.The patient must be >=18 and 2.Symptomatic ischemic heart disease (CCS class 1-4, Braunwald Class IB, IC, IIB, IIC, IIIB, IIIC, and/or objective evidence of myocardial ischemia); 3. Acceptable candidate for CABG; 4. The Patient is willing to comply with specified follow-up evaluations; 5. The Patient or legally authorized representative has been informed of the nature of the study, agrees to its provisions and has been provided written informed consent, approved by the appropriate Medical Ethics Committee (MEC), Institutional Review Board (IRB), or Human Research Ethics Committee (HREC). COHORT A 6. Patient with In-stent restenosis in Bare Metal Stent; 7. Patients with multi vessel coronary disease, may have undergone successful treatment ( 8. Target lesion (maximum length is 24 mm by visual estimate) located in a native coronary artery; 9. Reference vessel diameter must be >=3.0 to 10. Target lesion >=50% and 11. In case of thrombosis in the target lesion, the subject can be included after complete aspiration of the thrombus & cleaning of the lesion. COHORT B 6. Single de novo or non-stented restenotic lesion in the target vessel; 7. Patients with multi vessel coronary disease, may have undergone successful treatment ( 8. Target lesion located in a native coronary artery; 9. Target lesion (maximum length is 20 mm by visual estimate) covered by a single Amazonia CroCo• stent maximum 23 mm length ; 10. Reference vessel diameter must be >=3.0 to 11. Target lesion >=50% and 12. In case of thrombosis in the target lesion, the subject can be included after complete aspiration of the thrombus & cleaning of the lesion. COHORT C 6. Single non-stented stenosed lesion in the target vessel; 7. Patients with multi vessel coronary disease, may have undergone successful treatment ( 8. Target lesion (maximum length is 20 mm by visual estimate) covered by a single Amazonia CroCo• stent maximum 24 mm length ; 9. Reference vessel diameter must be >=3.0 to 10. Target lesion >=50% and 11. In case of thrombosis in the target lesion, the subject c
Exclusion criteria
Exclusion criteria: General Exclusion Criteria 1. Pregnant or nursing patients and those who plan pregnancy in the period up to 1 year following index procedure. Female patients of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test; 2. Patient has had a known diagnosis of acute myocardial infarction (AMI) within 72 hours preceding the index procedure (elevated troponin or CK-MB ï?³2 times upper limit of normal) or >72 hours preceding the index procedure and CK and CK-MB have not returned to within normal limits at the time of procedure; 3. The patient is currently experiencing clinical symptoms consistent with new onset AMI, such as nitrate unresponsive prolonged chest pain; 4. Impaired renal function (serum creatinine >2.0 mg/dL or 177 μmol/l) or on dialysis; 5. Platelet count 700,000 cells/mm3 or a WBC 6. Patient has a history of bleeding diathesis or coagulopathy or patients in whom anti-platelet and/or anticoagulant therapy is contraindicated; 7. Patient has received any organ transplant or is on a waiting list for any organ transplant; 8. Patient has other medical illness (e.g., cancer, known malignancy, or congestive heart failure) or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance with the protocol, confound the data interpretation or is associated with a limited life expectancy (i.e., less than 1 year); 9. Patient has a known hypersensitivity or contraindication to aspirin, heparin/bivalirudin, clopidogrel/ticlopidine, prasugrel, cobalt chromium alloy, Sirolimus, and/or contrast sensitivity that cannot be adequately pre-medicated; 10. Patient presents with cardiogenic shock; 11. Patient has current unstable cardiac arrhythmias that create hemodynamic instability; 12. Patient has extensive peripheral vascular disease that precludes safe 6 French sheath insertion; 13. Any significant medical condition which in the Investigatorâ??s opinion may interfere with the patientâ??s optimal participation in the study; 14. Currently participating in another investigational drug or device study or patient in inclusion in another investigational drug or device study during follow-up; COHORT A 15. Unprotected left main coronary artery disease with ï?³50% stenosis; 16. Patients with DES ISR or stent sandwich 17. Ostial target lesion(s); 18. Totally occluded target vessel (TIMI flow 0); 19. Calcified target lesion(s) which cannot be successfully pre dilated; 20. Target lesion has excessive tortuosity unsuitable for stent / balloon delivery and deployment; 21. Target lesion involving bifurcation with a side branch ï?³2.0 mm in diameter (either stenosis of both main vessel and major side branch or stenosis of just major side branch) that would require intervention of diseased side branch; 22. A significant ( >50%) stenosis proximal or distal to the target lesion that cannot be covered by same single device; 23. Diffuse distal disease to target lesion with impaired runoff; 24. Left ventricular ejection fraction (LVEF) ï?£30% (LVEF must be obtained within 6 months prior to the index procedure); 25. Pre-treatment with devices other than balloon angioplasty; 26. Prior stent within 10 mm of target lesion; <br
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical success as defined as freedom from MACE at 12 months. (MACE: death, myocardial infarction (MI), target lesion revascularization (TLR) and Target vessel revascularization (TVR) and stent thrombosis, both early and late occurrences will be assessed (as defined by the ARC definite and probable definitions) Reduction in late lumen loss as evaluated by QCA at 6 months The percentage (%) of in-stent neointimal tissue formation evaluated by IVUS (if available at the site) at 6 monthsTimepoint: 6 months angiographic follow up & IVUS follow up (if availabl at site) | — |
Secondary
| Measure | Time frame |
|---|---|
| Binary restenosis at 6-month Angiographic follow-up Timepoint: follow up at 30 days 3 months 6 months;Rate of stent thrombosis using ARC definition of definite and probable stent thrombosis and categorized as early, late or very late at 30 days and 6 monthsTimepoint: follow up at 30 days 6 months;Target Lesion Failure (TLF) defined as death, MI and ischemic Target Lesion Revascularization (TLR) at 30 days and 6 monthsTimepoint: 30 days and 6 months;Vascular complications from index procedure through hospital dischargeTimepoint: follow up at 30 days 3 months 6 months | — |
Countries
India
Contacts
Public ContactMr Manish Doshi
Concept Medicals Research Pvt. Ltd.
Outcome results
None listed