Prospective Multicenter Study to Characterize the REAL-WORLD EVIDENCE Regarding Safety and Performance of the PTCA NC Catheters Family

Completed

• Conditions: Coronary Artery Stenosis

• Registration Number: NCT05536180
• Lead Sponsor: Arthesys

Brief Summary

The purpose of this post market study is to collect clinical data of the Arthesys PTCA NC 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: 2022-09-07
• Study First Submitted QC: 2022-09-07
• Study First Posted: 2022-09-10
• Study Start: 2023-03-06
• Primary Completion: 2023-07-25
• Study Completion: 2023-07-25
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-21
• Last Update Posted: 2023-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Patients will be included as per Instructions for Use (IFU), Hospital standard of care and Good Clinical Practice (GCP):

• 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 be excluded as per IFU, Hospital standard of care and GCP. 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 procedure	Successful balloon dilatation without device related adverse event during the dilatation procedure
Efficacy endpoint	up to end of 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 procedure	Residual stenosis \< 50% and TIMI flow grade 3 (corelab assessment)
Performance - post-dilatation	up to end of procedure	Angiographic success of the device defined as \< 30% residual stenosis after angiography (corelab assessment)

Trial Locations

Locations (1)

Hopital Saint Louis; 🇫🇷 La Rochelle, France