The Canadian CABG or PCI in Patients With Ischemic Cardiomyopathy Trial (STICH3C)
NCT ID: NCT05427370
Last Updated: 2026-01-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
754 participants
INTERVENTIONAL
2023-06-22
2029-12-31
Brief Summary
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The primary objective is to determine whether CABG compared to PCI is associated with a reduction in all-cause death, stroke, spontaneous myocardial infarction (MI), urgent repeat revascularization (RR), or heart failure (HF) readmission over a median follow-up of 5 years in patients with multivessel/LM CAD and ischemic left ventricular dysfunction (iLVSD).
Eligible patients are considered by the local Heart Team appropriate and amenable for non-emergent revascularization by both modes of revascularization.
The secondary objectives are to describe the early risks of both procedures, and a comprehensive set of patient-reported outcomes longitudinally.
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Detailed Description
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The overarching aim of the STICH3C trial is to compare the clinical efficacy and safety of contemporary PCI and CABG to treat patients with multivessel/left main (LM) CAD and iLVSD.
Participants will be allocated in a 1:1 ratio to either study arm using permuted block randomization stratified for study center and acute coronary syndrome (ACS) presentation through a centrally controlled, automated, web system. Eligible patients who provide informed consent can be enrolled. It is expected that initial revascularization will take place within 2 weeks of randomization. Staged PCI is expected to take place within 90 days of randomization. The recruitment will occur over 3 years, with a total study duration of 7 years, and a median duration of follow-up of 5 years.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Revascularization by PCI
Revascularization will be attempted on/for significant lesions in major coronary vessels/side branches as planned by the local Heart Team, with the general recommendation of stenotic/occluded vessels with diameter \>2.0 mm for PCI. The Heart Team consists of a minimum of one heart failure cardiologist, one interventional cardiologist and one cardiac surgeon.
Revascularization by PCI
Contemporary, "State-of-the-art" PCI techniques will be encouraged in STICH3C, based on the most recent evidence and clinical practice guidelines recommendations. The best practices to be followed include the use of physiological and intravascular guidance, new-generation drug-eluting stents or scaffolds, rotational or orbital atherectomy for extensive calcifications, recommended bifurcation techniques, chronic total occlusion for viable segments by experienced operators, and trans-radial access.Planned temporary ventricular support is permitted by experienced operators when deemed indicated.
Revascularization by CABG
Revascularization will be attempted on/for significant lesions in major coronary vessels/side branches as planned by the local Heart Team, with the general recommendation of stenotic/occluded vessels with diameter \>1.5 mm for CABG. The Heart Team consists of a minimum of one heart failure cardiologist, one interventional cardiologist and one cardiac surgeon
Revascularization by CABG
The surgical revascularization strategy will be tailored according to the individual patient's coronary anatomy, left ventricular remodeling, aortic atherosclerosis, co-morbidities, local expertise, and surgical judgement. An internal thoracic artery will be used to graft the left anterior descending in all cases. Multi-arterial grafting may be considered in patients without significant co-morbidities and with expected limited vasopressor use, or in patients without saphenous conduits. Choice of on- vs. off-pump surgery is influenced by LV size, associated valvular disease, and aortic atherosclerosis, as well as surgeon experience, but on-pump surgery is recommended routinely. The use of adjunctive intra-aortic balloon support or other cardiac support is not routinely recommended in stable patients; the intra-aortic balloon support is the first line mechanical support.
Interventions
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Revascularization by PCI
Contemporary, "State-of-the-art" PCI techniques will be encouraged in STICH3C, based on the most recent evidence and clinical practice guidelines recommendations. The best practices to be followed include the use of physiological and intravascular guidance, new-generation drug-eluting stents or scaffolds, rotational or orbital atherectomy for extensive calcifications, recommended bifurcation techniques, chronic total occlusion for viable segments by experienced operators, and trans-radial access.Planned temporary ventricular support is permitted by experienced operators when deemed indicated.
Revascularization by CABG
The surgical revascularization strategy will be tailored according to the individual patient's coronary anatomy, left ventricular remodeling, aortic atherosclerosis, co-morbidities, local expertise, and surgical judgement. An internal thoracic artery will be used to graft the left anterior descending in all cases. Multi-arterial grafting may be considered in patients without significant co-morbidities and with expected limited vasopressor use, or in patients without saphenous conduits. Choice of on- vs. off-pump surgery is influenced by LV size, associated valvular disease, and aortic atherosclerosis, as well as surgeon experience, but on-pump surgery is recommended routinely. The use of adjunctive intra-aortic balloon support or other cardiac support is not routinely recommended in stable patients; the intra-aortic balloon support is the first line mechanical support.
Eligibility Criteria
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Inclusion Criteria
2. LVEF ≤40% quantified by either echocardiography, SPECT ventriculography, or magnetic resonance within 2 months of randomization;
3. Prognostically important multivessel CAD (triple vessel CAD or double vessel disease including the left anterior descending (LAD) or LM). Significant coronary stenosis is defined as ≥ 70% based on coronary angiography, and/or fractional flow reserve (FFR) ≤0.80 or instantaneous wave-free ratio (iFR) ≤0.89. For LM disease, significant coronary stenosis is defined as \>50% based on coronary angiography, intravascular ultrasound (IVUS) minimal luminal area (MLA) ≤6.0 mm2 (\<4.5 mm2 Asian descent), or equivalent optical coherence tomography (OCT) measurements;
4. The institutional Heart Team agrees that guideline-directed medical therapy (GDMT) has been initiated for ≥1 month in prevalent and newly diagnosed cases. In patients hospitalized with newly diagnosed iLVSD (with or without acute coronary syndrome (ACS)) requiring revascularization before discharge, GDMT needs to be initiated, when possible in-hospital before randomization, with the expectation that it will be titrated to maximally tolerated doses after revascularization;
5. Signed informed consent.
Exclusion Criteria
2. Recent (\<4 weeks) ST-elevation MI;
3. Concomitant severe valvular disease or other condition such as left ventricular aneurysm requiring surgical repair or replacement;
4. Planned major concomitant surgical procedures (LAAO and AF ablation surgical procedures permitted);
5. Prior PCI within the past 12 months (to reduce restenosis events from prior PCIs contributing to the primary outcome);
6. Prior cardiac surgery;
7. Prohibitive bleeding risk mandating avoidance of dual antiplatelet therapy;
8. Circumstances likely to lead to poor treatment adherence;
9. Severe end-organ dysfunction (such as dialysis, liver failure, respiratory failure, cancer) that reduces life expectancy to less than 5 years;
10. Current pregnancy;
11. Patient not amenable to both CABG or PCI according to the Heart Team;
12. Takotsubo/Takotsubo Cardiomyopathy/Broken Heart Syndrome.
18 Years
ALL
No
Sponsors
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Canadian Institutes of Health Research (CIHR)
OTHER_GOV
Weill Medical College of Cornell University
OTHER
Sunnybrook Health Sciences Centre
OTHER
Responsible Party
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Stephen E. Fremes
Professor of Surgery, University of Toronto
Principal Investigators
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Stephen Fremes, MD,MSc,FRCSC
Role: PRINCIPAL_INVESTIGATOR
Sunnybrook Health Sciences Center, Toronto, Canada
Mario Gaudino, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Weill Medical College of Cornell University, USA
Jean L Rouleau, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Montreal Heart Institute, QC Canada
Guillaume Maquis-Gravel, MD,MSc
Role: PRINCIPAL_INVESTIGATOR
Montreal Heart Institute, QC Canada
Locations
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Cedars-Sinai
Los Angeles, California, United States
Yale University
New Haven, Connecticut, United States
UofL Health, Inc
Louisville, Kentucky, United States
John Hopkins Hospital
Baltimore, Maryland, United States
Mayo Clinic
Rochester, Minnesota, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Medical University of Vienna
Vienna, , Austria
Heart Institute, Medical School of the University of Sao Paulo_INCOR
São Paulo, , Brazil
University of Calgary; Libin Cardiovascular Institute
Calgary, Alberta, Canada
Mackenzie Health Sciences Center
Edmonton, Alberta, Canada
Fraser Health; Royal Columbian Hospital
New Westminster, British Columbia, Canada
Providence Health
Vancouver, British Columbia, Canada
Queen Elizabeth II Hospital
Halifax, Nova Scotia, Canada
Hamilton General Hospital
Hamilton, Ontario, Canada
London Health Sciences Center, University Hospital
London, Ontario, Canada
Southlake Regional HC
Newmarket, Ontario, Canada
Ottawa Heart Institute
Ottawa, Ontario, Canada
Sunnybrook Health Sciences Center
Toronto, Ontario, Canada
St. Michael's
Toronto, Ontario, Canada
Toronto General Hospital
Toronto, Ontario, Canada
Center Hospitalier Universitaire de Montreal
Montreal, Quebec, Canada
Montreal Heart Institute
Montreal, Quebec, Canada
Hospital Sacre-Coeur
Montreal, Quebec, Canada
Institut de Cardiologie Quebec (QC) - Laval
Québec, Quebec, Canada
Jilin Heart Hospital
Jilin, Changchun, China
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, , China
Clinical Hospital Dubrava
Sušak, Zagreb, Croatia
Al Nas Hospital
Cairo, Qalyubia Governorate, Egypt
University Hospital Dusseldorf
Düsseldorf, , Germany
G Kuppuswamy Naidu Memorial Hospital (GKNM)
Palayam, Tamil Nadu, India
European Hospital, Via Portuense
Roma, RM, Italy
Instituto Mexicano del Seguro Social (IMSS)
Mexico City, , Mexico
Medical University of Silesia
Katowice, , Poland
Unidade Local de Saude Lisboa Ocidental (ULSLO)
Lisbon, , Portugal
Centro Hospitalar e Universitário Sao João
Porto, , Portugal
Dedinje Cardiovascular Institute
Belgrade, , Serbia
Hospital Clinic de Barcelona (ICCV)
Barcelona, L'Eixample, Spain
Hospital Clínico Universitario Virgen de la Arrixaca
El Palmar, Murcia, Spain
Hospital del Vinalopó
Alicante, , Spain
Hospital Universitario de Navarra
Pamplona, , Spain
Countries
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Central Contacts
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Facility Contacts
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Dominic Emerson
Role: primary
Marc Pelletier
Role: primary
Naresh Solanki
Role: primary
Jennifer Lawton
Role: primary
Rakesh Arora
Role: primary
Whady Armindo Hueb
Role: primary
Robert Miller
Role: primary
Jayan Nagendran
Role: primary
James Abel
Role: primary
Kim Anderson
Role: primary
Catherine Demers
Role: primary
David Nagpal
Role: primary
Liane Porepa
Role: primary
Marc Ruel
Role: primary
Stephen Fremes, MD,FRCS(C)
Role: primary
Akshay Bagai
Role: primary
Vivek Rao
Role: primary
Samer Mansour
Role: primary
Gilbert Gosselin
Role: primary
Erick Schampaert
Role: primary
Dimitri Kalavrouziotis
Role: primary
Massimo Lemma
Role: primary
Qiang Zhao
Role: primary
Igor Rudez
Role: primary
Mostafa M Abdrabou
Role: primary
Alexander Assmann
Role: primary
Chandrasekar Padmanabhan
Role: primary
Ruggero De Paulis
Role: primary
Jorge Escebedo
Role: primary
Miguel Sousa Uva
Role: primary
Adelino Leite-Moreira
Role: primary
Milan Milojevic
Role: primary
Jorge Alcocer
Role: primary
Sergio Juan Canovas Lopez
Role: primary
Jose Albors Martin
Role: primary
Rafael Sádaba
Role: primary
References
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Fremes SE, Marquis-Gravel G, Gaudino MFL, Jolicoeur EM, Bedard S, Masterson Creber R, Ruel M, Vervoort D, Wijeysundera HC, Farkouh ME, Rouleau JL; STICH3C Study Investigators. STICH3C: Rationale and Study Protocol. Circ Cardiovasc Interv. 2023 Aug;16(8):e012527. doi: 10.1161/CIRCINTERVENTIONS.122.012527. Epub 2023 Aug 15.
Other Identifiers
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v.1.6; August 22, 2025
Identifier Type: -
Identifier Source: org_study_id
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