Observational Study Evaluating the Management of Chronic Coronary Occlusions In France

NCT04281212 | Completed

• 2 other identifiers: 19.05.21.629082019-A01395-52
• Study Type: observational
• Target: 1,303
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Occlusion

Keywords

Chronic Coronary Occlusion; Peripheral Component Interconnect; Coronary angioplasty

Outcome Measures

Primary Outcomes (2)

• Choice of treatment in management of patients with CTO

  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

  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 Outcomes (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

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patient over 18 years old
• Patient with CTO

You may not qualify if:

• 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
• Patient over 18 years old
• Patient with CTO who has attempted angioplasty
• Patient with acute occlusion or less than 3 months.
• Patient demonstrating refusal to participate in the observatory

Sponsors & Collaborators

• French Cardiology Society: lead

Study Sites (1)

Clinique Saint Augustin

Bordeaux, 33075, France

Location

Related Publications (24)

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MeSH Terms

Conditions

Coronary Occlusion

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2020
• First Posted: February 24, 2020
• Study Start: March 9, 2020
• Primary Completion: December 16, 2021
• Study Completion: August 2, 2022
• Last Updated: September 16, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)