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NCT Number: NCT04281212

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.

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Key information

Conditions

Coronary Occlusion Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinique Saint Augustin

Bordeaux, 33075, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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))

Sponsors and collaborators

Lead sponsor

French Cardiology Society

Other

Registry information

Official study title

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

Acronym: ENCOCHE

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Feb 24, 2020
Registry last updated
Sep 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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