A clinical study to examine the safety and device procedural success of Relisys VEDA-R PTCA Dilatation catheter
- Conditions
- Health Condition 1: null- Patients with Coronary Artery Disorder
- Registration Number
- CTRI/2015/03/005641
- Lead Sponsor
- Relisys Medical Devices LTD
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 60
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
1.During the index procedure, the target lesion requires additional treatment with a cutting balloon, any artherectomy, any laser, thrombectomy.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Procedural Success and Device SuccessTimepoint: During procedure
- Secondary Outcome Measures
Name Time Method Major Adverse Cardiac EventsTimepoint: During procedure