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Observational Study Evaluating the Management of Chronic Coronary Occlusions In France (ENCOCHE)

F

French Cardiology Society

Status

Completed

Conditions

Coronary Occlusion

Study type

Observational

Funder types

Other

Identifiers

NCT04281212
2019-A01395-52 (Other Identifier)
19.05.21.62908

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,303 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

1,303 participants in 2 patient groups

CTO
Description:
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
Description:
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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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