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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-07-29

Study Completion Date

2023-07-15

Brief Summary

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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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Detailed Description

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Conditions

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Coronary Artery Stenosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Percutaneous Transluminal Coronary Angioplasty

Angioplasty intervention of coronary vessels or coronary bypass graft stenosis

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No