Observational Study Evaluating the Management of Chronic Coronary Occlusions In France

Completed

• Conditions: Coronary Occlusion

• Registration Number: NCT04281212
• Lead Sponsor: French Cardiology Society

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.

Study Timeline

• Study First Submitted: 2020-02-20
• Study First Submitted QC: 2020-02-20
• Study First Posted: 2020-02-24
• Study Start: 2020-03-09
• Primary Completion: 2021-12-16
• Study Completion: 2022-08-02
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-15
• Last Update Posted: 2022-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1303

Inclusion Criteria

• Patient over 18 years old
• Patient with CTO

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

Inclusion Criteria:

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

Exclusion Criteria:

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Success of the angioplasty for management of CTO	Through the end of hospitalization, an average of 5 days	Procedural success rate defined by residual stenosis ≤ 30% with a TIMI (Thrombolysis In Myocardial Infarction) 3 flow and no hospital complications at the end of the angioplasty procedure
Choice of treatment in management of patients with CTO	Through the end of hospitalization, an average of 5 days	Rate of patients with CTO treated by medical treatment alone and/or by surgery, and/or by angioplasty

Secondary Outcome Measures

Name	Time	Method
Rate of events occured after procedure of angioplasty during the hospitalization, for patients with CTO	Through the end of hospitalization, an average of 5 days	Major Adverse Cardiac and Cerebrovascular Events (MACCE - defined as the composite of death, Myocardial Infarction (MI), CerebroVascular Accident (CVA) or Stroke, or Target Vessel Revascularisation (TVR))

Trial Locations

Locations (1)

Clinique Saint Augustin; 🇫🇷 Bordeaux, France