Study to Check the safety and performance of Vector® PTCA Balloon Catheter
- Conditions
- Other type of myocardial infarction,
- Registration Number
- CTRI/2023/09/057758
- Lead Sponsor
- Sahajanand Laser Technology Ltd
- Brief Summary
A retrospective, single-arm, multi-center, observational, post-market clinical follow-up study to evaluate the safety and performance of Vector PTCA Balloon Catheter The Vector PTCA Balloon Catheter is also indicated for post-delivery expansion of balloon expandable stents .All consecutive patients who had been treated with Vector PTCA Balloon Catheter for balloon dilatation of stenotic portion of coronary artery or by pass graft stenosis for improving myocardial perfusion and/or post-delivery expansion of balloon expandable stents. The study Population is about 125 patients and The objective of this study is to evaluate the safety and performance of Vector PTCA Balloon Catheter in real-world settings.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 125
Patients who had been treated with Vector PTCA balloon Catheter.
Not provided
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Major Adverse Cardiac Events 12 Months
- Secondary Outcome Measures
Name Time Method Procedural success Device Success
Trial Locations
- Locations (2)
Maharaja Agrasen Hospital
🇮🇳Jalpaiguri, WEST BENGAL, India
North Bengal Neuro Centre Multispecialty Hospital
🇮🇳Jalpaiguri, WEST BENGAL, India
Maharaja Agrasen Hospital🇮🇳Jalpaiguri, WEST BENGAL, IndiaDr kumar AbhishekPrincipal investigator9800449121drkumarabhishek39@gmail.com