Observational Study Evaluating the Management of Chronic Coronary Occlusions In France

Study Overview
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Brief Summary
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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
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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.

Official Title
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Prospective, Multicentric Observational Study Evaluating the Management of Chronic Coronary Occlusions In France

Conditions
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Coronary Occlusion

Participation Criteria
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Eligibility Criteria
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Phase I 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CTO<br>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. | |
| CTO with attempted angioplasty<br>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 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Choice of treatment in management of patients with CTO | Rate of patients with CTO treated by medical treatment alone and/or by surgery, and/or by angioplasty | Through the end of hospitalization, an average of 5 days | 
| Success of the angioplasty for management of CTO | 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 | Through the end of hospitalization, an average of 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of events occured after procedure of angioplasty during the hospitalization, for patients with CTO | 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)) | Through the end of hospitalization, an average of 5 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Coronary Occlusion, Peripheral Component Interconnect, Coronary angioplasty