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CompletedNCT05232565Updated Jul 21, 2023

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

An observational study in Coronary Artery Stenosis, sponsored by Arthesys. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-07-21.

Sponsored by Arthesys · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
60
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Coronary Artery Stenosis

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03

In context

Coronary Stenosis

302 studies on the registry are indexed under Coronary Stenosis; 63 are open to participants now.

This study's enrollment of 60 is below the median of 200 across 132 observational studies indexed under Coronary Stenosis.

Browse Coronary Stenosis studies →

Lead sponsor

Arthesys is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients undergoing PTCA procedure

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
60 participants (actual)
Patient registry
No

Interventions

  • ProcedurePercutaneous Transluminal Coronary Angioplasty

    Angioplasty intervention of coronary vessels or coronary bypass graft stenosis

06

What researchers measure

Primary outcomes

  1. Efficacy endpoint

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

    Time frame: Up to end of PTCA procedure

  2. Safety endpoint

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

    Time frame: Up to end of PTCA procedure

Secondary outcomes

  1. Performance - pre-dilatation

    Residual stenosis \< 50% and TIMI flow grade 3

    Time frame: Up to end of PTCA procedure

  2. Performance - post-dilatation

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

    Time frame: Up to end of PTCA procedure

07

Study locations

1 site
  • Hôpital Saint Louis
    La Rochelle, 17000, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 21, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05232565
Lead sponsor
Arthesys
Responsible party
Sponsor
First posted
Feb 10, 2022
Start date
Jul 29, 2022
Primary completion
Jun 20, 2023
Completion
Jul 15, 2023
Last update
Jul 21, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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