NCT05232565

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 10, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

July 29, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2023

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2023

Completed
Last Updated

July 21, 2023

Status Verified

July 1, 2023

Enrollment Period

11 months

First QC Date

January 31, 2022

Last Update Submit

July 20, 2023

Conditions

Coronary Artery Stenosis

Outcome Measures

Primary Outcomes (2)

  • Efficacy endpoint

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

    Up to end of PTCA procedure

  • Safety endpoint

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

    Up to end of PTCA procedure

Secondary Outcomes (2)

  • Performance - pre-dilatation

    Up to end of PTCA procedure

  • Performance - post-dilatation

    Up to end of PTCA procedure

Interventions

Percutaneous Transluminal Coronary AngioplastyPROCEDURE

Angioplasty intervention of coronary vessels or coronary bypass graft stenosis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing PTCA procedure

You may qualify if:

  • 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

You may not qualify if:

  • \- 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Saint Louis

La Rochelle, 17000, France

Location

MeSH Terms

Conditions

Coronary Stenosis

Interventions

Angioplasty, Balloon, Coronary

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Angioplasty, BalloonAngioplastyCatheterizationTherapeuticsMyocardial RevascularizationCardiac Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeEndovascular ProceduresVascular Surgical ProceduresPercutaneous Coronary InterventionMinimally Invasive Surgical ProceduresThoracic Surgical ProceduresInvestigative Techniques

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2022

First Posted

February 10, 2022

Study Start

July 29, 2022

Primary Completion

June 20, 2023

Study Completion

July 15, 2023

Last Updated

July 21, 2023

Record last verified: 2023-07

Locations

FR(1)