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

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.

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Key information

Conditions

Coronary Artery Stenosis Cardiovascular Diseases Coronary Disease Coronary Stenosis Heart Diseases Myocardial Ischemia Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Hopital Saint Louis

La Rochelle, France

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Efficacy endpoint

Time frame: up to end of procedure

Balloon successfully reaching and crossing target location, successful inflation, deflation, and retrieval in the guiding catheter
Safety endpoint

Time frame: up to end of procedure

Successful balloon dilatation without device related adverse event during the dilatation procedure

Secondary outcomes

Performance - Pre-dilatation

Time frame: up to end of procedure

Residual stenosis < 50% and TIMI flow grade 3 (corelab assessment)
Performance - post-dilatation

Time frame: up to end of procedure

Angiographic success of the device defined as < 30% residual stenosis after angiography (corelab assessment)

Sponsors and collaborators

Lead sponsor

Arthesys

Industry

Registry information

Important dates

Study start: 2023
Primary completion: 2023
Study completion: 2023
First posted: Sep 10, 2022
Registry last updated: Nov 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed