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

Study Timeline

• Study First Submitted: 2022-01-31
• Study First Submitted QC: 2022-01-31
• Study First Posted: 2022-02-10
• Study Start: 2022-07-29
• Primary Completion: 2023-06-20
• Status Verified: 2023-07
• Study Completion: 2023-07-15
• Last Update Submitted: 2023-07-20
• Last Update Posted: 2023-07-21

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
Safety endpoint	Up to end of PTCA procedure	Successful balloon dilatation without device related adverse event during the dilatation procedure
Efficacy endpoint	Up to end of PTCA procedure	Balloon successfully reaching and crossing target location, successful inflation, deflation, and retrieval in the guiding catheter

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