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NCT05232565 Clinical Trial

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

Coronary Artery Stenosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05232565
Other study ID # ART-PTCA-01
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 29, 2022
Est. completion date July 15, 2023

Study information
Verified date July 2023
Source Arthesys
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date July 15, 2023
Est. primary completion date June 20, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Procedure:
• Percutaneous Transluminal Coronary Angioplasty
Angioplasty intervention of coronary vessels or coronary bypass graft stenosis

Locations
Country Name City State
France Hôpital Saint Louis La Rochelle

Sponsors (1)
Lead Sponsor Collaborator
Arthesys

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Efficacy endpoint Balloon successfully reaching and crossing target location, successful inflation, deflation, and retrieval in the guiding catheter Up to end of PTCA procedure
Primary Safety endpoint Successful balloon dilatation without device related adverse event during the dilatation procedure Up to end of PTCA procedure
Secondary Performance - pre-dilatation Residual stenosis < 50% and TIMI flow grade 3 Up to end of PTCA procedure
Secondary Performance - post-dilatation Angiographic success of the device defined as <30% residual stenosis after angiography Up to end of PTCA procedure
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