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Chronic Stable AnginaEuroCTONCT01760083

A Randomized Multicentre Trial to Evaluate the Utilization of Revascularization or Optimal Medical Therapy for the Treatment of Chronic Total Coronary Occlusions

A study testing Biolimus-eluting stent implantation in people with Chronic Stable Angina and Dyspnea, run by Euro CTO Club at 19 sites in 6 countries.

Completed

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

Official record
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Trial summary

CTOs are common among patients with angina, and are detected in around 20% of patients undergoing coronary angiography. Treatment of CTO has been found to constitute only 7% of PCI practice on average. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Stable Angina, Dyspnea, Coronary Occlusion
What is being tested?
Biolimus-eluting stent implantation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
450 participants
Where
19 sitesin 6 countries
Study dates
Jan 2013to Nov 2018
Phase
Interventional
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

Who may be able to join

  • ≥ 18 years of age with written informed consent
  • CTO in native coronary artery
  • a) Stable angina, or b) myocardial ischaemia in a territory supplied by CTO, and c) viability in akinetic myocardium (<50% transmural late enhancement on MRI or normal resting perfusion scan)
  • CTO located in segments 1-3 (RCA), 6-7 (LAD), 11-12 (LCx)
  • target artery ≥2.5mm

Who cannot join

  • AMI or NSTE-ACS within 1 month
  • Significant untreated coronary stenosis in a territory other than CTO
  • Patients with MVD and significant non-CTO stenoses where it is deemed unsafe to treat the non-CTO lesion first (e.g. Significant proximal LAD lesion with chronically occluded RCA)
  • Patient unsuitable for 12 month dual anti-platelet therapy
  • Any exclusion criteria for PCI or DES
  • Pregnant or nursing patients and those who plan pregnancy in the period up to 1 year following index procedure

Trial locations and contacts

19 sites in 6 countries.

19 sites in 6 countries

France5 sites

  • Clinique Saint-Augustin

    Bordeaux, 33074

  • CH de Lagny

    Lagny, 77405

  • Institut Hospitalier Jacques Cartier - ICPS

    Massy, 91300

  • Clinique Pasteur

    Toulouse, 31076

  • Rangueil university hospital

    Toulouse, 31076

Other trials in France

Germany4 sites

  • Zentralklinik Bad Berka

    Bad Berka, 99438

  • Herz-Zentrum Bad Krozingen

    Bad Krozingen, 79189

  • Main Taunus Kliniken

    Bad Soden, 65812

  • Klinikum Darmstadt

    Darmstadt, 64283

Other trials in Germany

Spain4 sites

  • Unidad de Cardiología Intervencionista Hospital de Sant Pau

    Barcelona, 08025

  • Hospital Clinic Villaroel

    Barcelona, 08036

  • Hospital Galdakao-Usansolo

    Galdakao, 48960

  • Cardiovascular Institute - Hospital Clinico San Carlos

    Madrid, 28040

Other trials in Spain

United Kingdom4 sites

  • Royal Sussex County Hospital - Brighton and Sussex University Hospitals

    Brighton, BN2 5BE

  • Royal Infirmary of Edinburgh

    Edinburgh, EH16 4SA

  • Department of Cardiovascular Sciences University of Leicester

    Leicester, LE3 9QP

  • National Heart and Lung Institute Imperial College

    London, SW7 2AZ

Other trials in United Kingdom

Italy1 site

  • Cardiac Catheterization Laboratory and Cardiovascular Interventional Unit Cannizzaro Hospita

    Catania, 95126

Other trials in Italy

Latvia1 site

  • Latvian Center of Cardiology Pauls Stradins Clinical University Hospital

    Riga, 1002

Other trials in Latvia

About this study

CTOs are common among patients with angina, and are detected in around 20% of patients undergoing coronary angiography. Treatment of CTO has been found to constitute only 7% of PCI practice on average. One of the reasons for the under-presentation of CTOs in PCI target lesions is the lack of evidence-based medical data on treatment indications, and the continued low level of accepted evidence for the treatment of CTOs by PCI in PCI guidelines.

Patients with a CTO represent patients with stable coronary artery disease. The COURAGE trial comparing PCI with optimal medical therapy in stable coronary disease did not show a difference in mortality or myocardial infarction between the two treatment options. However, CTOs were not included in the COURAGE trial. But that trial did confirm the superiority of PCI over OMT in controlling symptoms of angina, with a high cross-over rate to PCI. Whether PCI for CTO is superior to OMT in reducing MACE in those patients with a large ischaemic burden has never been tested in a randomized controlled trial.

Read more

While there is compelling evidence from registry studies of a clinical and prognostic benefit following successful PCI of CTO compared with PCI failure, there has been no randomized controlled trial of contemporary PCI using drug-eluting stents versus optimal medical therapy. The COURAGE trial nuclear sub-study confirms both that prognosis is closely related to the extent of residual ischaemia and that PCI is more effective in reducing residual ischaemia than optimal medical therapy alone. This confirms earlier retrospective data suggesting that the benefit of PCI is greatest in patients with moderate (10-20%) or severe (>20%) ischaemia.

Study hypothesis: PCI with Biolimus eluting stent implantation plus OMT will be superior to OMT alone in improving health status at 12-month follow-up, and will be noninferior with respect to the composite of all cause death/ non fatal MI at 36-month follow up, in patients with a CTO in an epicardial coronary artery >2.5 mm diameter and chronic stable angina with evidence of ischemia and viability in the territory subtended by the CTO

Being tested
Biolimus-eluting stent implantation
Medical subject headings
Angina, Stable, Dyspnea, Coronary Occlusion

What participants receive

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

  • Biolimus-eluting stent implantationDevice

    Also called Biosensors Biolimus-eluting stents of all sizes and lengths

    Recanalization of chronic coronary artery occlusion and subsequent implantation of one or ore Biosensor stents

Study groups in NCT01760083
Study groupRoleWhat they receive
Biolimus-eluting stent implantationActive comparatorPCI of CTO using a Biomatrix drug-eluting stent system + optimal medical therapy.
Receives: Device: Biolimus-eluting stent implantation
Medical therapyNo interventionOptimal medical therapy. Subsequent PCI only if symptoms of angina persist despite optimal medical therapy. At least 2 anti-anginal agents or the maximum tolerated anti-anginal therapy should be used before crossover. Medical therapy should include adequate ventricular rate-limiting medication (i.e. Beta-blocker or rate-limiting calcium antagonist) where appropriate.

What is being measured

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

  1. Quality of Life Seattle Angina Questionnaire (SAQ)

    Seattle Angina Questionnaire and EQ-5D for health outcomes measurement

    Measured: Baseline and 12 months

  2. Major cardiovascular events

    Cumulative composite endpoint of cardiovascular death, non-fatal MI at 3 years

    Measured: 36 months

Secondary outcomes (4)

  1. Safety and efficacy endpoints

    All cause mortality Cardiac mortality Myocardial Infarction Any hospitalization due to cardiovascular events (angina, congestive heart failure, arrythmias) Repeat revascularization

    Measured: 12 and 36 months

  2. Procedural complications

    Incl. periprocedural enzyme leak (defined by CK increase >3 times ULN); pericprocedural MI (new Q-wave or STEMI); pericardial tamponade, need for urgent CABG, CIN, death within 30 days, proven periprocedural cerebrovascular events

    Measured: baseline upto 36 months

  3. Protocol adherence

    Need to cross from OMT to PCI in Group 2 (after escalation up to maximum tolerated anti-anginal therapy and persistent unequivocal symptoms)

    Measured: 36 months

  4. Per protocol analysis

    primary endpoint comparison in patients who did have a successful revascularization compared to those patients treated medically who had no subsequent PCI

    Measured: 36 months

Timeline

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

  1. First posted3 Jan 2013 (estimated)
  2. Study startJan 2013
  3. Primary completionMay 2016
  4. Study completionNov 2018

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
450 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01760083
Sponsor's protocol ID
2011-005905-64
Acronym
EuroCTO
Status last verified
Jun 2019
First submitted
1 Jan 2013
Last updated
2 Jul 2019
Results posted
No
Data monitoring committee
Yes

Publications

  • Werner GS, Martin-Yuste V, Hildick-Smith D, Boudou N, Sianos G, Gelev V, Rumoroso JR, Erglis A, Christiansen EH, Escaned J, di Mario C, Hovasse T, Teruel L, Bufe A, Lauer B, Bogaerts K, Goicolea J, Spratt JC, Gershlick AH, Galassi AR, Louvard Y; EUROCTO trial investigators. A randomized multicentre trial to compare revascularization with optimal medical therapy for the treatment of chronic total coronary occlusions. Eur Heart J. 2018 Jul 7;39(26):2484-2493. doi: 10.1093/eurheartj/ehy220.

    PubMed 29722796

  • Werner GS, Hildick-Smith D, Martin Yuste V, Boudou N, Sianos G, Gelev V, Rumoroso JR, Erglis A, Christiansen EH, Escaned J, Di Mario C, Teruel L, Bufe A, Lauer B, Galassi AR, Louvard Y. Three-year outcomes of A Randomized Multicentre Trial Comparing Revascularization and Optimal Medical Therapy for Chronic Total Coronary Occlusions (EuroCTO). EuroIntervention. 2023 Sep 18;19(7):571-579. doi: 10.4244/EIJ-D-23-00312.

    PubMed 37482940

  • Azzalini L, Vo M, Dens J, Agostoni P. Myths to Debunk to Improve Management, Referral, and Outcomes in Patients With Chronic Total Occlusion of an Epicardial Coronary Artery. Am J Cardiol. 2015 Dec 1;116(11):1774-80. doi: 10.1016/j.amjcard.2015.08.050. Epub 2015 Sep 11.

    PubMed 26434510

Questions about this trial

What is this clinical trial studying?

A study testing Biolimus-eluting stent implantation in people with Chronic Stable Angina and Dyspnea, run by Euro CTO Club at 19 sites in 6 countries.

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 5 inclusion and 6 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 2 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in France, Germany, Spain, United Kingdom, Italy and 1 more country. 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?

Quality of Life Seattle Angina Questionnaire (SAQ) (time frame: Baseline and 12 months). 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 NCT01760083, which also lists 3 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 2 Jul 2019.

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