Health Condition 1: I209- Angina pectoris, unspecified
Conditions
Interventions
Intervention1: NIL: NIL
Sponsors
Sahajanand Medical Technologies Ltd. (SMT)
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patient must be at least 18 years of age 2. Patient or a legally authorized representative must provide written informed consent prior to any study related procedure 3. Patient must agree not to participate in any other clinical study during hospitalisation for the index procedure 4. Target lesion(s) can be treated with Pipit-NC PTCA Balloon Dilatation Catheter as per the current IFU.
Exclusion criteria
Exclusion criteria: Patient not meeting any of the above inclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Device Success 2. Procedural successTimepoint: Baseline (From the start to end of the interventional procedure) | — |
Secondary
| Measure | Time frame |
|---|---|
| Individual procedural parameters - Coronary perforation - Coronary dissection - Coronary thrombosis - Clinically significant arrhythmias (requiring intervention)Timepoint: Up to end of PTCA procedure;Safety endpoints - All-cause mortality - Any MI - Any revascularizationTimepoint: Up to hospital discharge | — |
Countries
India
Contacts
Public ContactDr Atul D Abhyankar
Shree B. D. Mehta Mahavir Heart Institute
Outcome results
None listed