A Randomized Multicentre Trial to Evaluate the Utilization of Revascularization or Optimal Medical Therapy for the Treatment of Chronic Total Coronary Occlusions (EuroCTO)
This study is currently recruiting participants.
Verified January 2013 by Euro CTO Club
Sponsor:
Euro CTO Club
Collaborators:
NHS Research and Development
Biosensors International
Asahi Intecc Co. Ltd.
Information provided by (Responsible Party):
Euro CTO Club
ClinicalTrials.gov Identifier:
NCT01760083
First received: January 1, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
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
| Condition | Intervention |
|---|---|
|
Chronic Stable Angina Dyspnea Coronary Occlusion |
Device: Biolimus-eluting stent implantation |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomized Multicentre Trial to Evaluate the Utilization of Revascularization or Optimal Medical Therapy for the Treatment of Chronic Total Coronary Occlusions |
Resource links provided by NLM:
Further study details as provided by Euro CTO Club:
Primary Outcome Measures:
- Quality of Life [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]Seattle Angina Questionnaire and EQ-5D for health outcomes measurement
- Major cardiovascular events [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]Cumulative composite endpoint of all-cause death, non-fatal MI at 3 years
Secondary Outcome Measures:
- Safety and efficacy endpoints [ Time Frame: 12 and 36 months ] [ Designated as safety issue: Yes ]All cause mortality Cardiac mortality Myocardial Infarction Any hospitalization due to cardiovascular events (angina, congestive heart failure, arrythmias)
- Prcedural complications [ Time Frame: baseline upto 36 months ] [ Designated as safety issue: Yes ]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
- Protocol adherence [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]Need to cross from OMT to PCI in Group 2 (after escalation up to maximum tolerated anti-anginal therapy and persistent unequivocal symptoms)
- Per protocol analysis [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]primary endpoint comparison in patients who did have a successful revascularization compared to those patients treated medically who had no subsequent PCI
Other Outcome Measures:
- Health-economic analysis [ Time Frame: 12 and 36 months ] [ Designated as safety issue: No ]Economic assessment & cost efficacy
| Estimated Enrollment: | 1200 |
| Study Start Date: | March 2012 |
| Estimated Study Completion Date: | March 2017 |
| Estimated Primary Completion Date: | March 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Biolimus-eluting stent implantation
PCI of CTO using a Biomatrix drug-eluting stent system + optimal medical therapy.
|
Device: Biolimus-eluting stent implantation
Recanalization of chronic coronary artery occlusion and subsequent implantation of one or ore Biosensor stents
Other Name: Biosensors Biolimus-eluting stents of all sizes and lengths
|
|
No Intervention: Medical therapy
Optimal 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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- ≥ 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
Exclusion Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01760083
Locations
| France | |
| Clinique Saint-Augustin | Recruiting |
| Bordeaux, France, 33074 | |
| Contact: Jean-Louis Leymarie, MD 33 (0)5 57 81 07 81 | |
| Principal Investigator: Jean-Lois Leymarie, MD | |
| CH de Lagny | Recruiting |
| Lagny, France, 77405 | |
| Contact: Simone Elhadad, MD 33 (0)1 64 30 76 22 | |
| Principal Investigator: Simon Elhadad, MD | |
| Institut Hospitalier Jacques Cartier - ICPS | Recruiting |
| Massy, France, 91300 | |
| Contact: Yves Louvard, MD 33 (0)1 60 13 61 68 | |
| Principal Investigator: Yves Louvard, MD | |
| Clinique Pasteur | Recruiting |
| Toulouse, France, 31076 | |
| Contact: Didier Tchetche, MD 33 (0)5 62 21 31 31 | |
| Principal Investigator: Didier Tchetche, MD | |
| Rangueil university hospital | Recruiting |
| Toulouse, France, 31076 | |
| Contact: Nicolas Boudou, MD 33 (0)5-61-32-26-65 | |
| Principal Investigator: Nicolas Boudou, MD | |
| Germany | |
| Zentralklinik Bad Berka | Active, not recruiting |
| Bad Berka, Germany, 99438 | |
| Herz-Zentrum Bad Krozingen | Active, not recruiting |
| Bad Krozingen, Germany, 79189 | |
| Main Taunus Kliniken | Recruiting |
| Bad Soden, Germany, 65812 | |
| Contact: Nicolaus Reifart, MD PhD n.reifart@reifart-partner.de | |
| Principal Investigator: Nicolaus Reifart, MD PhD | |
| Klinikum Darmstadt | Recruiting |
| Darmstadt, Germany, 64283 | |
| Contact: Gerald S Werner, MD 4906151010706401 | |
| Principal Investigator: Hiller Moehlis, MD | |
| Sub-Investigator: Gerald S Werner, MD | |
| HELIOS Klinikum Wuppertal | Active, not recruiting |
| Wuppertal, Germany, 42117 | |
| Italy | |
| Cardiac Catheterization Laboratory and Cardiovascular Interventional Unit Cannizzaro Hospita | Not yet recruiting |
| Catania, Italy, 95126 | |
| Contact: Alfredo R Galassi, MD PhD +39-095-7436210 | |
| Principal Investigator: Alfredo R Galassi, MD PhD | |
| Latvia | |
| Latvian Center of Cardiology Pauls Stradins Clinical University Hospital | Recruiting |
| Riga, Latvia, 1002 | |
| Contact: Andrejs A Erglis, MD PhD +371 67 06 93 79 | |
| Principal Investigator: Andrejs A Erglis, MD PhD | |
| Sub-Investigator: Aigars Lismanis, MD | |
| Spain | |
| Hospital Clinic Villaroel | Active, not recruiting |
| Barcelona, Spain, 08036 | |
| Unidad de Cardiología Intervencionista Hospital de Sant Pau | Active, not recruiting |
| Barcelona, Spain, 08025 | |
| Hospital Galdakao-Usansolo | Recruiting |
| Galdakao, Spain, 48960 | |
| Contact: Ramon Rumoroso, MD rumo@secardiologia.es | |
| Principal Investigator: Ramon Rumoroso, MD | |
| Cardiovascular Institute - Hospital Clinico San Carlos | Active, not recruiting |
| Madrid, Spain, 28040 | |
| United Kingdom | |
| Royal Sussex County Hospital - Brighton and Sussex University Hospitals | Not yet recruiting |
| Brighton, United Kingdom, BN2 5BE | |
| Contact: David Hildick-Smith, MD '+44 1273 696955 | |
| Principal Investigator: David Hildick-Smith, MD | |
| Royal Infirmary of Edinburgh | Not yet recruiting |
| Edinburgh, United Kingdom, EH16 4SA | |
| Contact: James Spratt, MD +44 131 536 1000 | |
| Principal Investigator: James Spratt, MD | |
| Department of Cardiovascular Sciences University of Leicester | Not yet recruiting |
| Leicester, United Kingdom, LE3 9QP | |
| Contact: Anthony Gershlick, MD PhD +44 7850 57 46 38 | |
| Principal Investigator: Anthony Gershlick, MD PhD | |
| National Heart and Lung Institute Imperial College | Not yet recruiting |
| London, United Kingdom, SW7 2AZ | |
| Contact: Carlo Di Mario, MD PhD +44 207 351 8616 | |
| Principal Investigator: Carlo Di Mario, MD PhD | |
Sponsors and Collaborators
Euro CTO Club
NHS Research and Development
Biosensors International
Asahi Intecc Co. Ltd.
Investigators
| Principal Investigator: | Gerald S Werner, MD PhD | Klinikum Darmstadt, Darmstadt Germany |
More Information
Additional Information:
No publications provided
| Responsible Party: | Euro CTO Club |
| ClinicalTrials.gov Identifier: | NCT01760083 History of Changes |
| Other Study ID Numbers: | 2011-005905-64 |
| Study First Received: | January 1, 2013 |
| Last Updated: | January 1, 2013 |
| Health Authority: | European Union: European Medicines Agency |
Additional relevant MeSH terms:
|
Dyspnea Coronary Occlusion Angina Pectoris Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory Signs and Symptoms |
Coronary Disease Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases Chest Pain Pain |
ClinicalTrials.gov processed this record on May 19, 2013