Post-market study of Pipit-NC Balloon Dilatation Catheter
Not Applicable
- Conditions
- Health Condition 1: I209- Angina pectoris, unspecified
- Registration Number
- CTRI/2023/08/056616
- Lead Sponsor
- Sahajanand Medical Technologies Ltd. (SMT)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
Patient not meeting any of the above inclusion criteria
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Device Success <br/ ><br>2. Procedural successTimepoint: Baseline <br/ ><br>(From the start to end of the interventional procedure)
- Secondary Outcome Measures
Name Time Method Individual procedural parameters <br/ ><br>- Coronary perforation <br/ ><br>- Coronary dissection <br/ ><br>- Coronary thrombosis <br/ ><br>- Clinically significant arrhythmias (requiring intervention)Timepoint: Up to end of PTCA procedure;Safety endpoints <br/ ><br>- All-cause mortality <br/ ><br>- Any MI <br/ ><br>- Any revascularizationTimepoint: Up to hospital discharge