Prospective Multicenter Study to Characterize the REAL-WORLD EVIDENCE Regarding Safety and Performance of the PTCA Catheters Family
Completed
- Conditions
- Coronary Artery Stenosis
- Registration Number
- NCT05232565
- Lead Sponsor
- Arthesys
- Brief Summary
The purpose of this Post market Study is to collect clinical data of the Arthesys PTCA catheters family during angioplasty intervention of coronary vessels or coronary bypass graft stenosis to support MDR submission.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
- Patient with a Percutaneous intervention to a native coronary or coronary bypass graft indication
- Patient >18 years
- Patient who understands the trial requirements and the treatment procedures and provides written informed consent
Exclusion Criteria
- Patients will not be included if they are under judicial protection, guardianship or curatorship or if they are deprived of their liberty by judicial or administrative decision.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy endpoint Up to end of PTCA procedure Balloon successfully reaching and crossing target location, successful inflation, deflation, and retrieval in the guiding catheter
Safety endpoint Up to end of PTCA procedure Successful balloon dilatation without device related adverse event during the dilatation procedure
- Secondary Outcome Measures
Name Time Method Performance - pre-dilatation Up to end of PTCA procedure Residual stenosis \< 50% and TIMI flow grade 3
Performance - post-dilatation Up to end of PTCA procedure Angiographic success of the device defined as \<30% residual stenosis after angiography
Trial Locations
- Locations (1)
Hôpital Saint Louis
🇫🇷La Rochelle, France