NCT05536180

Brief Summary

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.

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 Mar 2023

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

September 7, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 10, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

March 6, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 25, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2023

Completed
Last Updated

November 22, 2023

Status Verified

November 1, 2023

Enrollment Period

5 months

First QC Date

September 7, 2022

Last Update Submit

November 21, 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 procedure

  • Safety endpoint

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

    up to end of procedure

Secondary Outcomes (2)

  • Performance - Pre-dilatation

    up to end of procedure

  • Performance - post-dilatation

    up to end of procedure

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing PTCA procedure

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Saint Louis

La Rochelle, France

Location

MeSH Terms

Conditions

Coronary Stenosis

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Design

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

Study Record Dates

First Submitted

September 7, 2022

First Posted

September 10, 2022

Study Start

March 6, 2023

Primary Completion

July 25, 2023

Study Completion

July 25, 2023

Last Updated

November 22, 2023

Record last verified: 2023-11

Locations

FR(1)