Health Condition 1: null- Patients with Coronary Artery Disorder
Conditions
Interventions
Intervention1: Veda-R Dilatation Catheter: Veda-R NC and SC catheters are being tested in selected population
Sponsors
Relisys Medical Devices LTD
Eligibility
Inclusion criteria
Inclusion criteria: Clinical: 1. Patient â?? above 18 years of age and able to give informed consent. 2. Patient with stenotic lesions in coronary arteries or bypass graft stenosis that is suitable for percutaneous coronary intervention (PCI). 3. The patient has single or multiple vessel coronary artery disease and clinical evidence of ischemic heart disease, acute coronary syndrome, stable or unstable angina, silent ischemia, and/or a positive functional study. 4. Female patients of childbearing potential must have a negative pregnancy test within seven (7) days before the procedure. 5. Patient willing to give the consent. Angiographic: 6. Subject must have de novo or restenotic lesion(s) in native coronary arteries or bypass grafts that are suitable for percutaneous coronary intervention. 7. A maximum of three lesions, including at least one target lesion, in up to two coronary arteries. 8. Target and non-target lesions must be located in different coronary arteries or bypass grafts. 9. Target lesion(s) must have a diameter stenosis of >=70% by visual estimation
Exclusion criteria
Exclusion criteria: 1. During the index procedure, the target lesion requires additional treatment with a cutting balloon, any artherectomy, any laser, thrombectomy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Procedural Success and Device SuccessTimepoint: During procedure | — |
Secondary
| Measure | Time frame |
|---|---|
| Major Adverse Cardiac EventsTimepoint: During procedure | — |
Countries
India
Contacts
Public ContactS Prashanth
CARE Hospital
Outcome results
None listed