Clinical trial NCT04281212: Observational Study Evaluating the Management of Chronic Coronary Occlusions In France
Official title: Prospective, Multicentric Observational Study Evaluating the Management of Chronic Coronary Occlusions In France
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Occlusion
Keywords: Chronic Coronary Occlusion
Peripheral Component Interconnect
Coronary angioplasty
Lead sponsor: French Cardiology Society
Sponsor class: OTHER
First posted: 2020-02-24
Enrollment: 1303
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: As defined by the European CTO Club consensus, a chronic occlusion (CTO) is a total coronary occlusion, TIMI 0 (without anterograde coronary flow), more than 3 months old.

To assess the CTO, the JCTO score will be used to assess the clinical and angiographic criteria of the lesions.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Choice of treatment in management of patients with CTO
timeFrame: Through the end of hospitalization, an average of 5 days
measure: Success of the angioplasty for management of CTO
timeFrame: Through the end of hospitalization, an average of 5 days
Secondary outcomes:
measure: Rate of events occured after procedure of angioplasty during the hospitalization, for patients with CTO
timeFrame: Through the end of hospitalization, an average of 5 days
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Clinique Saint Augustin
Study officials:
References:
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