Observational Study Evaluating the Management of Chronic Coronary Occlusions In France

Coronary Occlusion Clinical Trial

— ENCOCHE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04281212
• Other study ID #: 19.05.21.62908
• Secondary ID: 2019-A01395-52
• Status: Completed
• Start date: March 9, 2020
• Est. completion date: August 2, 2022

Study information

• Verified date: September 2022
• Source: French Cardiology Society
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1303
• Est. completion date: August 2, 2022
• Est. primary completion date: December 16, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Occlusion

Locations

Country	Name	City	State
France	Clinique Saint Augustin	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
French Cardiology Society

Country where clinical trial is conducted

France, 

References & Publications (24)

Christakopoulos GE, Christopoulos G, Carlino M, Jeroudi OM, Roesle M, Rangan BV, Abdullah S, Grodin J, Kumbhani DJ, Vo M, Luna M, Alaswad K, Karmpaliotis D, Rinfret S, Garcia S, Banerjee S, Brilakis ES. Meta-analysis of clinical outcomes of patients who underwent percutaneous coronary interventions for chronic total occlusions. Am J Cardiol. 2015 May 15;115(10):1367-75. doi: 10.1016/j.amjcard.2015.02.038. Epub 2015 Feb 18. Review. — View Citation

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Farooq V, Serruys PW, Garcia-Garcia HM, Zhang Y, Bourantas CV, Holmes DR, Mack M, Feldman T, Morice MC, Ståhle E, James S, Colombo A, Diletti R, Papafaklis MI, de Vries T, Morel MA, van Es GA, Mohr FW, Dawkins KD, Kappetein AP, Sianos G, Boersma E. The negative impact of incomplete angiographic revascularization on clinical outcomes and its association with total occlusions: the SYNTAX (Synergy Between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery) trial. J Am Coll Cardiol. 2013 Jan 22;61(3):282-94. doi: 10.1016/j.jacc.2012.10.017. Epub 2012 Dec 19. — View Citation

Fefer P, Knudtson ML, Cheema AN, Galbraith PD, Osherov AB, Yalonetsky S, Gannot S, Samuel M, Weisbrod M, Bierstone D, Sparkes JD, Wright GA, Strauss BH. Current perspectives on coronary chronic total occlusions: the Canadian Multicenter Chronic Total Occlusions Registry. J Am Coll Cardiol. 2012 Mar 13;59(11):991-7. doi: 10.1016/j.jacc.2011.12.007. — View Citation

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Kahn JK. Angiographic suitability for catheter revascularization of total coronary occlusions in patients from a community hospital setting. Am Heart J. 1993 Sep;126(3 Pt 1):561-4. — View Citation

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Olivari Z, Rubartelli P, Piscione F, Ettori F, Fontanelli A, Salemme L, Giachero C, Di Mario C, Gabrielli G, Spedicato L, Bedogni F; TOAST-GISE Investigators. Immediate results and one-year clinical outcome after percutaneous coronary interventions in chronic total occlusions: data from a multicenter, prospective, observational study (TOAST-GISE). J Am Coll Cardiol. 2003 May 21;41(10):1672-8. — View Citation

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Tomasello SD, Boukhris M, Giubilato S, Marzà F, Garbo R, Contegiacomo G, Marzocchi A, Niccoli G, Gagnor A, Varbella F, Desideri A, Rubartelli P, Cioppa A, Baralis G, Galassi AR. Management strategies in patients affected by chronic total occlusions: results from the Italian Registry of Chronic Total Occlusions. Eur Heart J. 2015 Dec 1;36(45):3189-98. doi: 10.1093/eurheartj/ehv450. Epub 2015 Sep 2. — View Citation

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* Note: There are 24 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Rate of events occured after procedure of angioplasty during the hospitalization, for patients with CTO	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