NCT06446102

Brief Summary

Research Involving Human Persons (RIHP 3) focusing on the treatment of type 0-0-1 bifurcation lesions in routine practice. Multicenter Study. To retrieve and analyze the details of different angioplasty techniques used in this type of bifurcation lesion (Medina 0-0-1) in order to describe current practice and search for predictors of clinical events.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
273

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2023

Shorter than P25 for all trials

Geographic Reach
2 countries

3 active sites

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

Study Start

First participant enrolled

December 11, 2023

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 29, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 29, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 17, 2024

Completed
20 days until next milestone

First Posted

Study publicly available on registry

June 6, 2024

Completed
Last Updated

June 10, 2024

Status Verified

June 1, 2024

Enrollment Period

18 days

First QC Date

May 17, 2024

Last Update Submit

June 6, 2024

Conditions

Coronary Bifurcation Stenosis

Outcome Measures

Primary Outcomes (1)

  • Major Adverse Cardiovascular Events

    Composite of cardiovascular death rate, myocardial infarction rate and target vessel revascularization rate.

    3 years

Secondary Outcomes (1)

  • Target lesion revascularization

    3 years

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

In this trial, approximately 300 patients will be recruited from the Hôpital Privé Jacques Cartier in Massy, Clinique Pasteur in Toulouse, and Maasstad Hospital in Rotterdam between 2016 and 2022.

You may qualify if:

  • Male or female aged 18 years and older,
  • Who underwent angioplasty for a coronary bifurcation lesion of type 0-0-1 between 2016 and 2022.

You may not qualify if:

  • \- Opposing the collection and processing of necessary data and refusing additional telephone follow-up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Institut Cardiovasculaire Paris Sud, Hôpital Privé Jacques Cartier

Massy, 91300, France

Location

Clinique Pasteur

Toulouse, 31076, France

Location

Maasstad Ziekenhuis

Rotterdam, 3079 DZ, Netherlands

Location

Study Officials

  • Francesca SANGUINETI, MD

    ICPS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 17, 2024

First Posted

June 6, 2024

Study Start

December 11, 2023

Primary Completion

December 29, 2023

Study Completion

December 29, 2023

Last Updated

June 10, 2024

Record last verified: 2024-06

Locations

FR(2)NL(1)