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Observational Study Evaluating the Management of Chronic Coronary Occlusions In France

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04281212
Acronym
ENCOCHE
Enrollment
1303
Registered
2020-02-24
Start date
2020-03-09
Completion date
2022-08-02
Last updated
2022-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Occlusion

Keywords

Chronic Coronary Occlusion, Peripheral Component Interconnect, Coronary angioplasty

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.

Interventions

None listed

Sponsors

French Cardiology Society
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
Choice of treatment in management of patients with CTOThrough the end of hospitalization, an average of 5 daysRate of patients with CTO treated by medical treatment alone and/or by surgery, and/or by angioplasty
Success of the angioplasty for management of CTOThrough the end of hospitalization, an average of 5 daysProcedural 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

MeasureTime frameDescription
Rate of events occured after procedure of angioplasty during the hospitalization, for patients with CTOThrough the end of hospitalization, an average of 5 daysMajor 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))

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026