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

September 15, 2022 updated by: French Cardiology Society

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

1303

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France, 33075
        • Clinique Saint Augustin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Choice of treatment in management of patients with CTO
Time Frame: 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
Through the end of hospitalization, an average of 5 days
Success of the angioplasty for management of CTO
Time Frame: 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
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
Time Frame: 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))
Through the end of hospitalization, an average of 5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

French Cardiology Society

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 9, 2020

Primary Completion (ACTUAL)

December 16, 2021

Study Completion (ACTUAL)

August 2, 2022

Study Registration Dates

First Submitted

February 20, 2020

First Submitted That Met QC Criteria

February 20, 2020

First Posted (ACTUAL)

February 24, 2020

Study Record Updates

Last Update Posted (ACTUAL)

September 16, 2022

Last Update Submitted That Met QC Criteria

September 15, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19.05.21.62908
  • 2019-A01395-52 (OTHER: ANSM, France)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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