Physiology-guided vs Angiography-guided Non-culprit Lesion Complete Revascularization for Acute MI & Multivessel Disease

Coronary Artery Disease Clinical Trial

— COMPLETE-2  

Official title:

A Randomized Trial of Physiology-guided vs Angiography-guided Non-culprit Lesion Complete Revascularization Strategies & an Observational Study of Optical Coherence Tomography in Patients With Acute MI & Multivessel Coronary Artery Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05701358
• Other study ID #: COMPLETE-2
• Status: Recruiting
• Phase: N/A
• Start date: June 22, 2023
• Est. completion date: June 2028

Study information

• Verified date: February 2024
• Source: Population Health Research Institute
• Contact: COMPLETE-2 Project Office
• Phone: (905) 521-2100
• Email: complete-2[@]phri.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

COMPLETE-2 is a prospective, multi-centre, randomized controlled trial comparing a strategy of physiology-guided complete revascularization to angiography-guided complete revascularization in patients with acute ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation myocardial infarction (NSTEMI) and multivessel coronary artery disease (CAD) who have undergone successful culprit lesion Percutaneous Coronary Intervention (PCI). COMPLETE-2 OCT is a large scale, prospective, multi-centre, observational, imaging study of patients with STEMI or NSTEMI and multivessel CAD in a subset of eligible COMPLETE-2 patients.

Description:

COMPLETE-2 STUDY OBJECTIVES 1. To determine whether a strategy of physiology-guided complete revascularization is non-inferior to a strategy of angiography-guided complete revascularization on the efficacy composite outcome of cardiovascular (CV) death, new myocardial infarction (MI) or ischemia-driven revascularization (IDR). 2. To determine whether a physiology-guided complete revascularization strategy is superior to an angiography-guided complete revascularization strategy in reducing the safety composite outcome of clinically significant bleeding, stroke, stent thrombosis or contrast-associated acute kidney injury.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5100
• Est. completion date: June 2028
• Est. primary completion date: June 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients presenting with STEMI or type 1 NSTEMI and within 72 hours of successful culprit-lesion PCI

2. Residual coronary artery disease defined as at least 1 additional non-infarct-related

coronary artery stenosis that meets all of the following criteria:

1. Amenable to successful treatment with PCI

2. At least 50% diameter stenosis by visual estimation

3. At least 2.5 mm in diameter

3. Planned complete revascularization strategy for qualifying MI

Exclusion Criteria:

1. Planned or prior coronary artery bypass graft (CABG) surgery

2. Inability to clearly identify a culprit lesion for STEMI or NSTEMI based on angiographic appearance and/or ECG changes and/or regional wall motion abnormalities

3. Prior PCI of a non-culprit lesion in a different vessel from the culprit lesion within 45 days of randomization

4. Planned medical treatment of all qualifying non-culprit lesions (i.e., no PCI)

5. Presence of severe non-culprit-lesion stenosis with reduced epicardial flow (TIMI flow = 2) or >90% visual diameter stenosis

6. Presence of a chronic total occlusion (CTO) if it is the only qualifying non-culprit lesion (patients with a CTO plus additional qualifying non-culprit lesions are eligible)

7. The only qualifying non-culprit lesion is in the same vessel territory as the culprit lesion

8. Baseline STEMI or NSTEMI was due to a suspected non-atherothrombotic mechanism such as type 2 MI (supply-demand mismatch), including spontaneous coronary artery dissection or coronary artery embolism

9. Non-cardiovascular co-morbidity with expected life expectancy <2 years

10. Any other medical, geographic, or social factor making study participation impractical or precluding 5 year follow-up

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Coronary Artery Disease
• Coronary Disease
• Infarction
• Myocardial Infarction
• Myocardial Ischemia

Intervention

Procedure:
• Physiology-guided NCL PCI
For RFR, PCI will be performed as per local practice for all lesions with RFR =0.89. For FFR, PCI will be performed as per local practice for all NCLs with FFR =0.80.
• Angiography-guided NCL PCI
PCI will be performed as per local practice

Locations

Country	Name	City	State
Canada	University of Calgary - Foothills Medical Centre	Calgary
Canada	University of Alberta Hospital, Mazankowski Heart	Edmonton
Canada	Hamilton Health Sciences	Hamilton
Canada	St. Mary's General Hospital	Kitchener
Canada	Centre Hospitalier de l'Universite de Montreal	Montréal
Canada	Hopital du Sacre-Coeur de Montreal	Montréal
Canada	Southlake Regional Health Centre	Newmarket
Canada	University of Ottawa Heart Institute	Ottawa
Canada	Royal University Hospital	Saskatoon
Canada	Newfoundland and Labrador Health Services	St. John's
Canada	St. Michael's Hospital (Unity Health Toronto)	Toronto
Canada	Sunnybrook Health Sciences Centre	Toronto
Denmark	Aalborg University Hospital	Aalborg
Denmark	Rigshospitalet - Copenhagen University Hospital	Copenhagen
Germany	University Heart & Vascular Center Hamburg	Hamburg
Italy	Azienda Ospedaliero - Universitaria di Ferrara	Ferrara
Italy	Azienda USL-IRCCS di Reggio Emilia, Reggio	Reggio Emilia
Italy	Sant Andrea Hospital - Sapienza University	Rome
Sweden	Karolinska University Hospital	Huddinge
Sweden	Skane University Hospital	Lund
Sweden	Danderyd Hospital	Stockholm
Sweden	Umeå University Hospital	Umeå
United Kingdom	Kettering General Hospital	Kettering
United Kingdom	Sheffield Teaching Hospitals	Sheffield
United States	The Johns Hopkins University School of Medicine	Baltimore	Maryland
United States	Bassett Medical Center	Cooperstown	New York
United States	UCLA	Los Angeles	California
United States	Cardiovascular Research Institute of Kansas	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Population Health Research Institute

Countries where clinical trial is conducted

United States,  Canada,  Denmark,  Germany,  Italy,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy: Time to first occurrence of the composite of CV death, new MI, or IDR		at study completion, a minimum of 2 years
Primary	Safety: Time to first occurrence of the composite of clinically significant bleeding, stroke, stent thrombosis, or contrast-associated acute kidney injury.		at study completion, a minimum of 2 years
Secondary	Time to first occurrence of the composite of CV death or new MI.		at study completion, a minimum of 2 years
Secondary	Net clinical outcome: Time to first occurrence of the composite of CV death, new MI, clinically significant bleeding, stroke, stent thrombosis or contrast-associated acute kidney injury.		at study completion, a minimum of 2 years