Health Condition 1: null- Cardiac Arterial Disease
Conditions
Interventions
Intervention1: SELUTIONTM Pro Drug(Sirolimus) Drug Coated Balloon: The intervention agent is Drug Coated Balloon. The drug coated is Sirolimus and the concentration of it is 3µg/mm2. The drug is coat
Sponsors
Bio India Interventional Technologies Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age of the subject >18 years. 2. The subject has been informed of the nature of the clinical trial and hr/she or the subjects legal representative has provided written informed consent prior to any clinical trial related procedure, as approved by the appropriate Ethics Committee of the clinical site. 3. Patients must agree to return for all required post index procedure follow up visits. 4. Patients are eligible for coronary revascularization by means of PTCA. 5. The subject is either suffering from instent stenosis or having a de novo coronary artery disease requiring PCI. 6. Target vessel reference diameter is between 2.00mm and 3.00 mm. 7. The target lesion length must be 8. Treatment of multiple lesions with DCB is not allowed. 9. The target lesion must have been successfully crossed with a guide wire and there must be successful pre-dilation of target lesion, in the absence of early recoil, significant remaining stenosis or flow limiting dissection. 10. Per physicians opinion patient can tolerate DAPT for 30 days, and patient agrees to be compliant for the same for 30 days. 11. Percutaneous interventions for lesions in a nontarget or target vessel are allowed if done 30 days prior to the index procedure.
Exclusion criteria
Exclusion criteria: 1. Known hypersensitivity or contradiction to aspirin, heparin other anticoagulant/anti-platelet therapies, sirolimus or sensitivity to contrast media which cannot be adequately pre-medicated. 2. Any contraindication as mentioned in the SELUTION TM Pro DCB Instructions For Use 3. Concurrent medical condition with a life expectancy, from the Investigators opinion, of less than 12 months. 4. Currently participating in an investigational drug or another device clinical trial that has not completed the primary endpoint or that clinically interferes with the current clinical trial endpoints. 5. Patients with history of MI or thrombolysis within 30 days prior index procedure. 6. History of stroke within 3 months prior to index procedure. 7. Previous surgical or interventional procedure within 15 days prior to index procedure. 8. Composite target lesion length is >18 mm. 9. Treatment of target lesions that requires more than 2 overlapping Investigational Devices. 10. Known required use of adjunctive treatment modalities( laser, atherectomy, cryoplasty, scoring/cutting balloon, etc) 11. Remaining acute or sub acute thrombosis in the target vessel.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate freedom from device and procedure-related mortality.Timepoint: 30 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.To evaluate % DS, binary restenosis rate and LLL by angiography.Timepoint: 6 Months;2. To evaluate Major Adverse Cardiac Events (MACE) defined as composite of Target Lesion. Revascularization (TLR), cardiac death and myocardial infarction (MI).Timepoint: 6 Months;3. To assess efficacy on the basis of Target Lesion Revascularization (TLR), Target Vessel Revascularization (TVR).Timepoint: 6 Months;4. Assess thrombosis in the target vessel 6 monthsTimepoint: 6 Months;To assess clinical and device success.Timepoint: 6 Months | — |
Countries
India
Contacts
Public ContactAishwarya Suresh Mokashi
Bio India Interventional Technologies Pvt Ltd
Outcome results
None listed