Observational Study Evaluating the Management of Chronic Coronary Occlusions In France

NCT ID: NCT04281212

Last Updated: 2022-09-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1303 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-03-09
• Study Completion Date: 2022-08-02

Brief Summary

Data from the literature on the management of Chronic Coronary Occlusions (CTO) in France highlight a lack of epidemiological data on these patients at the national level.

For this reason, it was decided to set up this large-scale survey in order to have a picture of the management of patients with chronic coronary occlusion in France, to study the prevalence of CTOs in France as well as their management (medical, surgical or interventional), and then by analysing more precisely, over a second survey period, CTO angioplasties in terms of success rates, complications, medico-economic impact.

Detailed Description

This exhaustive and descriptive study of CTO patients, performed on a set of approximately 100 interventional cardiology centers in France, will be conducted in two steps:

• 1st step: This collection will be done over one month, the objective of which will be to photograph the therapeutic choice in the management of CTO (drug, surgical, endovascular approach).
• 2nd step: a second collection will be carried out over a period of two months, the objective of which will be to evaluate, in patients presenting a CTO with an attempt at angioplasty, the success of the procedure.

Conditions

Coronary Occlusion

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

CTO

Period of 1 month in the participating centers, during which all the patients with CTO and responding to all selection criteria may be included in the study, in order to describe which therapeutic choices have been chosen for this type of patient.

No interventions assigned to this group

CTO with attempted angioplasty

Period of 2 months in the participating centers, during which all the patients for whom an angioplasty has been attempted after a CTO, and responding to all selection criteria, may be included in the study, in order to evaluate the success of the procedure

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Patient over 18 years old
• Patient with CTO

• Patient over 18 years old
• Patient with CTO who has attempted angioplasty

Exclusion Criteria

• Patient with acute occlusion or subocclusive lesion or CTO of less than 3 months
• Patient expressing his refusal to participate in the observatory

Phase II

• Patient with acute occlusion or less than 3 months.
• Patient demonstrating refusal to participate in the observatory

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

French Cardiology Society

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Clinique Saint Augustin

Bordeaux, , France

Countries

France

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Other Identifiers

2019-A01395-52

Identifier Type: OTHER

Identifier Source: secondary_id

19.05.21.62908

Identifier Type: -

Identifier Source: org_study_id