Overview Study details Eligibility Things to know Research Study plan

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Overview Study details Eligibility Things to know Research Study plan

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

NARECRUITING

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.

Study details:

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.

Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

Patients presenting with STEMI or type 1 NSTEMI and within 72 hours of successful culprit-lesion PCI
Residual coronary artery disease defined as at least 1 additional non-infarct-related coronary artery stenosis that meets all of the following criteria:
Amenable to successful treatment with PCI
At least 50% diameter stenosis by visual estimation
At least 2.5 mm in diameter
Planned complete revascularization strategy for qualifying MI

Exclusion criteria

Planned or prior coronary artery bypass graft (CABG) surgery
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
Prior PCI of a non-culprit lesion in a different vessel from the culprit lesion within 45 days of randomization
Planned medical treatment of all qualifying non-culprit lesions (i.e., no PCI)
Presence of severe non-culprit-lesion stenosis with reduced epicardial flow (TIMI flow ≤ 2) or >90% visual diameter stenosis
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)
The only qualifying non-culprit lesion is in the same vessel territory as the culprit lesion
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
Non-cardiovascular co-morbidity with expected life expectancy <2 years
Any other medical, geographic, or social factor making study participation impractical or precluding 5 year follow-up

Eligibility

Age eligible for study : NA

Healthy volunteers accepted : No

Gender eligible for study: ALL

Things to know

Study dates

Study start:

Primary completion:

Study completion finish:

Study type

TREATMENT

Phase

Study ID

NCT05701358

Intervention or treatment

PROCEDURE: Physiology-guided NCL PCI

PROCEDURE: Angiography-guided NCL PCI

Conditions

Acute Myocardial Infarction
Coronary Artery Disease

Condition: Acute Myocardial Infarction, Coronary Artery Disease
PROCEDURE: Physiology-guided NCL PCI and other drugs
Westmead, New South Wales, Australia
Sponsor: Population Health Research Institute

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Are you running this trial?

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Research sites nearby

Closest Location:

Westmead Hospital

Select from list below to view details:

Westmead Hospital
Westmead, New South Wales, Australia

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Who is running the clinical trial?

PHRI

Population Health Research Institute

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
ACTIVE_COMPARATOR: Physiology-guided Non-Culprit-Lesion (NCL) PCI Patients randomized to this group will have their physiology assessment using RFR and/or FFR of all qualifying NCLs that were identified prior to randomization. Other validated non-hyperemic physiology ratios (eg. iFR) may only be used when RFR is not available.	Procedure: Physiology-guided NCL PCI
OTHER: Angiography-guided NCL PCI Patients randomized to this group will undergo routine staged PCI of all qualifying NCLs that were identified prior to randomization.	Procedure: Angiography-guided NCL PCI

What is the study measuring?

Primary Outcome

Measure	Description	Time Frame
Efficacy: Time to first occurrence of the composite of CV death, new MI, or IDR	Not Specified	at study completion, a minimum of 2 years
Safety: Time to first occurrence of the composite of clinically significant bleeding, stroke, stent thrombosis, or contrast-associated acute kidney injury.	Not Specified	at study completion, a minimum of 2 years

Secondary Outcome

Measure	Description	Time Frame
Time to first occurrence of the composite of CV death or new MI.	Not Specified	at study completion, a minimum of 2 years
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.	Not Specified	at study completion, a minimum of 2 years

Are you running this trial?If you're a clinic or sponsor, you can claim this study.

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References

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

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