CTRI/2022/09/045311Active, not recruitingPhase 4
A prospective, post marketing clinical follow up study to evaluate the safety and performance of Sirolimus Eluting Coronary Stainless Steel Stent System in Real World Indian population.
Trial Snapshot
- Phase
- Phase 4
- Status
- Active, not recruiting
- Sponsor
- Translumina Therapeutics LLP
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Pms
Eligibility Criteria
Inclusion Criteria
- •Real world, all comersâ?? Indian Patients who meet below mentioned criteria:
- •1. Age > 18 years
- •2. Patients who can provide informed consent form in writing to provide data for the study.
- •3. Patients who allow their data to be collected for the study at predefined follow-up periods.
- •4. Patients that need a treatment with drug eluting stent.
- •5. Presence of one or more coronary artery stenosis in a native coronary artery or a saphenous vein graft from 2.0 to 4.0 mm in diameter planned for PCI with Study device-Sirolimus Eluting Coronary Stent System (SS) (one or multiple stents).
- •6. In case of multiple vessel disease all vessels must be treated with Study device-Sirolimus Eluting Coronary Stent System (SS) only
- •7. No limitation on the number of treated lesions, vessels, and lesion length
Exclusion Criteria
- •Patients who meet below mention criteria will be excluded from the study:
- •1. Patients treated with stent other than Study device-Sirolimus Eluting Coronary Stent System (SS)
- •2. Patients have other planned coronary vascular treatments after index procedure in same sitting.
- •3. Patient unwilling or unable to comply with the postoperative visits necessary for data collection.
- •4. Patient is pregnant or nursing an infant or child or planning to become pregnant while in the study.
- •5. Concurrent medical condition with a life expectancy of less than 3 years
- •6. Patient is a recipient of heart transplant
- •7. Known hypersensitivity or contraindication to aspirin, heparin, clopidogrel or ticagrelor or similar drugs, or any other analogue or derivative, stainless steel or contrast media
- •8. Prior stenting in target or non-target vessel within 90 days before index procedure
- •9. Patient participating in other study
Investigators
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