Health Condition 1: I209- Angina pectoris, unspecified
Conditions
Interventions
Intervention1: NIL: NIL
Sponsors
Dr Atul D Abhyankar
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years 2. Patient with symptomatic coronary artery disease 3. Patients with large vessels, who require treatment with the Supraflex Cruz stent with diameter >3.0 mm 4. The target lesions must be primary and in situ coronary lesions, and in the case of multiple target lesions, they must be located in different epicardial vessels. 5. Able to understand and sign the written informed consent form
Exclusion criteria
Exclusion criteria: 1. Contraindication to antiplatelet therapy or a history of hypersensitivity to sirolimus or structurally related compounds 2. Patient with any medical condition that would make him/her inappropriate for treatment with the Supraflex Cruz stent as per the current IFU or in the opinion of the Investigator 3. No suitable anatomy for OCT scan in the opinion of investigator 4. Internal mammary artery (IMA) due to a stent thrombosis 5. Heavily calcified lesion and/or calcified lesion which cannot be successfully pre-dilated 6. Previously implanted stent in target lesion(s) 7. Lesions in coronary artery bypass grafts 8. Known serum creatinine level >2.5mg/dl or presence or history of renal failure 9. Cardiogenic shock 10. Cerebrovascular accident or transient ischemic attack in the last 6 months. 11. Left ventricular ejection fraction (LVEF) <30% at the most recent evaluation
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Segment level analysis (cross-sectional areas of stent, lumen, prolapse & isolated intraluminal defect using OCT examinationsTimepoint: After Index Procedure | — |
Primary
| Measure | Time frame |
|---|---|
| Acute stent recoil, defined as a decrease in the mean stent area (MSA, mm2) from baseline to approximately 30 minutes after stent implantation using OCT examinations.Timepoint: After Index Procedure | — |
Countries
India
Contacts
Public ContactDr Atul D Abhyankar
Shree B.D. Mehta Mahavir Heart Institute
Outcome results
None listed