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OpenTrials
Completed

NCT Number: NCT05232565

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Saint Louis

La Rochelle, 17000, France

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Percutaneous Transluminal Coronary Angioplasty

Procedure

Angioplasty intervention of coronary vessels or coronary bypass graft stenosis

Primary outcomes

  1. Efficacy endpoint

    Time frame: Up to end of PTCA procedure

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

  2. Safety endpoint

    Time frame: Up to end of PTCA procedure

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

Secondary outcomes

  1. Performance - pre-dilatation

    Time frame: Up to end of PTCA procedure

    Residual stenosis < 50% and TIMI flow grade 3

  2. Performance - post-dilatation

    Time frame: Up to end of PTCA procedure

    Angiographic success of the device defined as <30% residual stenosis after angiography

Sponsors and collaborators

Lead sponsor

Arthesys

Industry

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 10, 2022
Registry last updated
Jul 21, 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.

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