Coronary OcclusionENCOCHENCT04281212

Observational Study Evaluating the Management of Chronic Coronary Occlusions In France

An observational study of Coronary Occlusion, run by French Cardiology Society at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Coronary Occlusion
How many people: 1,303 participants
Where: 1 siteFrance
Study dates: 9 Mar 2020to 2 Aug 2022
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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.

Who may be able to join

Patient over 18 years old
Patient with CTO
Patient over 18 years old
Patient with CTO who has attempted angioplasty

Who cannot join

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 with acute occlusion or less than 3 months.
Patient demonstrating refusal to participate in the observatory

Trial locations and contacts

1 site in 1 country.

France1 site

Clinique Saint Augustin
Bordeaux, 33075

Other trials in France

About this study

Official title: Prospective, Multicentric 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.

Read the 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.

Conditions: Coronary Occlusion
Keywords: Chronic Coronary Occlusion, Peripheral Component Interconnect, Coronary angioplasty
Medical subject headings: Coronary Occlusion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04281212
Study group	Role	What they receive
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

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
Measured: 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
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))
Measured: Through the end of hospitalization, an average of 5 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Mar 20202 Aug 2022

First posted24 Feb 2020
Study start9 Mar 2020
Primary completion16 Dec 2021
Study completion2 Aug 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (24)Papers the sponsor has linked to this study.
Other trials for Coronary OcclusionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 1,303 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04281212
Sponsor's protocol ID: 19.05.21.62908
Other IDs: 2019-A01395-52
Acronym: ENCOCHE
Status last verified: Sep 2022
First submitted: 20 Feb 2020
Last updated: 16 Sep 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Di Mario C, Werner GS, Sianos G, Galassi AR, Buttner J, Dudek D, Chevalier B, Lefevre T, Schofer J, Koolen J, Sievert H, Reimers B, Fajadet J, Colombo A, Gershlick A, Serruys PW, Reifart N. European perspective in the recanalisation of Chronic Total Occlusions (CTO): consensus document from the EuroCTO Club. EuroIntervention. 2007 May;3(1):30-43. No abstract available.
PubMed 19737682
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. doi: 10.1016/0002-8703(93)90404-w.
PubMed 8362709
Werner GS, Gitt AK, Zeymer U, Juenger C, Towae F, Wienbergen H, Senges J. Chronic total coronary occlusions in patients with stable angina pectoris: impact on therapy and outcome in present day clinical practice. Clin Res Cardiol. 2009 Jul;98(7):435-41. doi: 10.1007/s00392-009-0013-5. Epub 2009 Mar 18.
PubMed 19294443
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.
PubMed 22402070
Garcia S, Sandoval Y, Roukoz H, Adabag S, Canoniero M, Yannopoulos D, Brilakis ES. Outcomes after complete versus incomplete revascularization of patients with multivessel coronary artery disease: a meta-analysis of 89,883 patients enrolled in randomized clinical trials and observational studies. J Am Coll Cardiol. 2013 Oct 15;62(16):1421-31. doi: 10.1016/j.jacc.2013.05.033. Epub 2013 Jun 7.
PubMed 23747787
Sachdeva R. Effect of revascularization of chronic total occlusion on tandem stenoses in a "donor" artery. Tex Heart Inst J. 2014 Oct 1;41(5):547-50. doi: 10.14503/THIJ-13-3569. eCollection 2014 Oct.
PubMed 25425993
Stone GW, Reifart NJ, Moussa I, Hoye A, Cox DA, Colombo A, Baim DS, Teirstein PS, Strauss BH, Selmon M, Mintz GS, Katoh O, Mitsudo K, Suzuki T, Tamai H, Grube E, Cannon LA, Kandzari DE, Reisman M, Schwartz RS, Bailey S, Dangas G, Mehran R, Abizaid A, Moses JW, Leon MB, Serruys PW. Percutaneous recanalization of chronically occluded coronary arteries: a consensus document: part II. Circulation. 2005 Oct 18;112(16):2530-7. doi: 10.1161/CIRCULATIONAHA.105.583716. No abstract available.
PubMed 16230504
Serruys PW, Morice MC, Kappetein AP, Colombo A, Holmes DR, Mack MJ, Stahle E, Feldman TE, van den Brand M, Bass EJ, Van Dyck N, Leadley K, Dawkins KD, Mohr FW; SYNTAX Investigators. Percutaneous coronary intervention versus coronary-artery bypass grafting for severe coronary artery disease. N Engl J Med. 2009 Mar 5;360(10):961-72. doi: 10.1056/NEJMoa0804626. Epub 2009 Feb 18.
PubMed 19228612
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. doi: 10.1016/s0735-1097(03)00312-7.
PubMed 12767645
Srivatsa SS, Edwards WD, Boos CM, Grill DE, Sangiorgi GM, Garratt KN, Schwartz RS, Holmes DR Jr. Histologic correlates of angiographic chronic total coronary artery occlusions: influence of occlusion duration on neovascular channel patterns and intimal plaque composition. J Am Coll Cardiol. 1997 Apr;29(5):955-63. doi: 10.1016/s0735-1097(97)00035-1.
PubMed 9120181
Katsuragawa M, Fujiwara H, Miyamae M, Sasayama S. Histologic studies in percutaneous transluminal coronary angioplasty for chronic total occlusion: comparison of tapering and abrupt types of occlusion and short and long occluded segments. J Am Coll Cardiol. 1993 Mar 1;21(3):604-11. doi: 10.1016/0735-1097(93)90091-e.
PubMed 8436741
Rathore S, Matsuo H, Terashima M, Kinoshita Y, Kimura M, Tsuchikane E, Nasu K, Ehara M, Asakura Y, Katoh O, Suzuki T. Procedural and in-hospital outcomes after percutaneous coronary intervention for chronic total occlusions of coronary arteries 2002 to 2008: impact of novel guidewire techniques. JACC Cardiovasc Interv. 2009 Jun;2(6):489-97. doi: 10.1016/j.jcin.2009.04.008.
PubMed 19539251
de Labriolle A, Bonello L, Roy P, Lemesle G, Steinberg DH, Xue Z, Kaneshige K, Suddath WO, Satler LF, Kent KM, Pichard AD, Lindsay J, Waksman R. Comparison of safety, efficacy, and outcome of successful versus unsuccessful percutaneous coronary intervention in "true" chronic total occlusions. Am J Cardiol. 2008 Nov 1;102(9):1175-81. doi: 10.1016/j.amjcard.2008.06.059. Epub 2008 Aug 27.
PubMed 18940287
Suero JA, Marso SP, Jones PG, Laster SB, Huber KC, Giorgi LV, Johnson WL, Rutherford BD. Procedural outcomes and long-term survival among patients undergoing percutaneous coronary intervention of a chronic total occlusion in native coronary arteries: a 20-year experience. J Am Coll Cardiol. 2001 Aug;38(2):409-14. doi: 10.1016/s0735-1097(01)01349-3.
PubMed 11499731
Hoye A, van Domburg RT, Sonnenschein K, Serruys PW. Percutaneous coronary intervention for chronic total occlusions: the Thoraxcenter experience 1992-2002. Eur Heart J. 2005 Dec;26(24):2630-6. doi: 10.1093/eurheartj/ehi498. Epub 2005 Sep 23.
PubMed 16183693

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Coronary Occlusion trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prospective, Multicentric Observational Study Evaluating the Management of Chronic Coronary Occlusions In France
ClinicalTrials.gov ID: NCT04281212
Acronym / sponsor ID: ENCOCHE / 19.05.21.62908
Conditions: Coronary Occlusion
Keywords: Chronic Coronary Occlusion, Peripheral Component Interconnect, Coronary angioplasty
Study type: Observational
Recruitment status: Completed
Enrolment: 1,303 participants (actual)
Lead sponsor: French Cardiology SocietyUniversity, hospital or other
Study start: 9 Mar 2020 (actual)
Primary completion: 16 Dec 2021 (actual)
Study completion: 2 Aug 2022 (actual)
First posted: 24 Feb 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

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

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
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

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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.

Key inclusion criteria (4 listed)

Patient over 18 years old
Patient with CTO
Patient over 18 years old
Patient with CTO who has attempted angioplasty

Key exclusion criteria (5 listed)

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 with acute occlusion or less than 3 months.
Patient demonstrating refusal to participate in the observatory

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

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
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

1 secondary outcome

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2022.
Background: PubMed 19737682Di Mario C, Werner GS, Sianos G, Galassi AR, Buttner J, Dudek D, Chevalier B, Lefevre T, Schofer J, Koolen J, Sievert H, Reimers B, Fajadet J, Colombo A, Gershlick A, Serruys PW, Reifart N. European perspective in the recanalisation of Chronic Total Occlusions (CTO): consensus document from the EuroCTO Club. EuroIntervention. 2007 May;3(1):30-43. No abstract available.
Background: PubMed 8362709Kahn 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. doi: 10.1016/0002-8703(93)90404-w.
Background: PubMed 19294443Werner GS, Gitt AK, Zeymer U, Juenger C, Towae F, Wienbergen H, Senges J. Chronic total coronary occlusions in patients with stable angina pectoris: impact on therapy and outcome in present day clinical practice. Clin Res Cardiol. 2009 Jul;98(7):435-41. doi: 10.1007/s00392-009-0013-5. Epub 2009 Mar 18.
Background: PubMed 22402070Fefer 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.
Background: PubMed 23747787Garcia S, Sandoval Y, Roukoz H, Adabag S, Canoniero M, Yannopoulos D, Brilakis ES. Outcomes after complete versus incomplete revascularization of patients with multivessel coronary artery disease: a meta-analysis of 89,883 patients enrolled in randomized clinical trials and observational studies. J Am Coll Cardiol. 2013 Oct 15;62(16):1421-31. doi: 10.1016/j.jacc.2013.05.033. Epub 2013 Jun 7.
Background: PubMed 25425993Sachdeva R. Effect of revascularization of chronic total occlusion on tandem stenoses in a "donor" artery. Tex Heart Inst J. 2014 Oct 1;41(5):547-50. doi: 10.14503/THIJ-13-3569. eCollection 2014 Oct.
Background: PubMed 16230504Stone GW, Reifart NJ, Moussa I, Hoye A, Cox DA, Colombo A, Baim DS, Teirstein PS, Strauss BH, Selmon M, Mintz GS, Katoh O, Mitsudo K, Suzuki T, Tamai H, Grube E, Cannon LA, Kandzari DE, Reisman M, Schwartz RS, Bailey S, Dangas G, Mehran R, Abizaid A, Moses JW, Leon MB, Serruys PW. Percutaneous recanalization of chronically occluded coronary arteries: a consensus document: part II. Circulation. 2005 Oct 18;112(16):2530-7. doi: 10.1161/CIRCULATIONAHA.105.583716. No abstract available.
Background: PubMed 19228612Serruys PW, Morice MC, Kappetein AP, Colombo A, Holmes DR, Mack MJ, Stahle E, Feldman TE, van den Brand M, Bass EJ, Van Dyck N, Leadley K, Dawkins KD, Mohr FW; SYNTAX Investigators. Percutaneous coronary intervention versus coronary-artery bypass grafting for severe coronary artery disease. N Engl J Med. 2009 Mar 5;360(10):961-72. doi: 10.1056/NEJMoa0804626. Epub 2009 Feb 18.
Background: PubMed 12767645Olivari 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. doi: 10.1016/s0735-1097(03)00312-7.
Background: PubMed 9120181Srivatsa SS, Edwards WD, Boos CM, Grill DE, Sangiorgi GM, Garratt KN, Schwartz RS, Holmes DR Jr. Histologic correlates of angiographic chronic total coronary artery occlusions: influence of occlusion duration on neovascular channel patterns and intimal plaque composition. J Am Coll Cardiol. 1997 Apr;29(5):955-63. doi: 10.1016/s0735-1097(97)00035-1.
Background: PubMed 8436741Katsuragawa M, Fujiwara H, Miyamae M, Sasayama S. Histologic studies in percutaneous transluminal coronary angioplasty for chronic total occlusion: comparison of tapering and abrupt types of occlusion and short and long occluded segments. J Am Coll Cardiol. 1993 Mar 1;21(3):604-11. doi: 10.1016/0735-1097(93)90091-e.
Background: PubMed 19539251Rathore S, Matsuo H, Terashima M, Kinoshita Y, Kimura M, Tsuchikane E, Nasu K, Ehara M, Asakura Y, Katoh O, Suzuki T. Procedural and in-hospital outcomes after percutaneous coronary intervention for chronic total occlusions of coronary arteries 2002 to 2008: impact of novel guidewire techniques. JACC Cardiovasc Interv. 2009 Jun;2(6):489-97. doi: 10.1016/j.jcin.2009.04.008.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Occlusion, run by French Cardiology Society at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Choice of treatment in management of patients with CTO (time frame: Through the end of hospitalization, an average of 5 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04281212, which also lists 24 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2022; AzTrials last refreshed its copy on 6 Nov 2026.