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

Sponsor
French Cardiology Society (Other)
Overall Status
Unknown status
CT.gov ID
NCT04281212
Collaborator
(none)
1,750
Enrollment
1
Location
8.8
Anticipated Duration (Months)
199.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1750 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Prospective, Multicentric Observational Study Evaluating the Management of Chronic Coronary Occlusions In France
    Actual Study Start Date :
    Mar 9, 2020
    Anticipated Primary Completion Date :
    Oct 1, 2020
    Anticipated Study Completion Date :
    Dec 1, 2020

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. 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

    2. 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

    Secondary Outcome Measures

    1. 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))

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Clinique Saint Augustin Bordeaux France 33075

    Sponsors and Collaborators

    • French Cardiology Society

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    French Cardiology Society
    ClinicalTrials.gov Identifier:
    NCT04281212
    Other Study ID Numbers:
    • 19.05.21.62908
    • 2019-A01395-52
    First Posted:
    Feb 24, 2020
    Last Update Posted:
    Mar 12, 2020
    Last Verified:
    Mar 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by French Cardiology Society
    Chronic Coronary Occlusion
    Peripheral Component Interconnect
    Coronary angioplasty
    Additional relevant MeSH terms:
    Coronary Occlusion

    Study Results

    No Results Posted as of Mar 12, 2020