Efficacy of Immediate Versus Staged Complete Revascularization in Patients With NSTE-ACS and Multivessel Disease (FUTURE II)

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRenJi Hospital

About this trial

This is a prospective, multi-center, randomized controlled, open-label, blinded endpoint assessment study. The objective is to compare the 1-year incidence of major adverse cardiovascular and cerebrovascular events (MACCE) between two treatment strategies-immediate complete revascularization and staged complete revascularization-in NSTE-ACS patients with multivessel disease (MVD).

NSTE-ACS patients who meet other the inclusion and exclusion criteria will be randomized into the following two groups after signing an informed consent form:

Intervention group Immediate Complete Revascularization: Emergency PCI for the culprit vessel is performed successfully, and simultaneous PCI is conducted for non-culprit vessels that meet the defined criteria (visually estimated diameter ≥2.5 mm, eligible for successful PCI, and visually estimated maximum diameter stenosis ≥ 70% or positive coronary physiology testing).

Control group During emergency intervention, PCI is performed only on the culprit vessel. Elective PCI is then conducted for non-culprit vessels that meet the defined criteria (visually estimated diameter ≥ 2.5 mm, eligible for successful PCI, and visually estimated maximum diameter stenosis ≥ 70% or positive coronary physiology testing)-either during the current emergency hospitalization or within 6 weeks after the culprit vessel PCI.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age: 18 years or older.

Patients with intermediate-to-high risk NSTE-ACS who meet the diagnostic criteria specified in current guideline, complicated by multivessel coronary artery disease, and have successfully undergone PCI for the culprit vessel.

PCI within 72 hours of diagnosis.

Accompanied by multivessel disease: defined as at least one non-culprit artery that meets the following conditions: a diameter of ≥2.5 mm by visual inspection, which can be successfully subjected to PCI, and the most severe diameter stenosis rate by visual inspection is at least 70% or positive coronary physiology testing.

Disqualifiers

Have received thrombolytic treatment.

Cardiogenic shock or SBP< 90 mmHg.

Patients in whom the culprit vessel cannot be clearly identified.

Left main coronary artery lesion, non-infarct-related arteries are CTO lesions or severely calcified lesions, complex lesions that require the use of special devices such as rotational ablation/laser.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Immediate Complete Revascularization

    Device

    Immediate Complete Revascularization: Emergency PCI for the culprit vessel is performed successfully, and simultaneous PCI is conducted for non-culprit vessels that meet the defined criteria (visually estimated diameter ≥2.5 mm, eligible for successful PCI, and visually estimated maximum diameter stenosis ≥ 70% or positive coronary physiology testing).

  • Staged Complete Revascularization

    Device

    During emergency intervention, PCI is performed only on the culprit vessel. Elective PCI is then conducted for non-culprit vessels that meet the defined criteria (visually estimated diameter ≥ 2.5 mm, eligible for successful PCI, and visually estimated maximum diameter stenosis ≥ 70% or positive coronary physiology testing)-either during the current emergency hospitalization or within 6 weeks after the culprit vessel PCI.

Treatment groups

1,904 Participants
are divided into 2 treatment groups
Group A: Immediate Complete RevascularizationExperimental treatment 1 intervention
Group B: Staged Complete RevascularizationActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Major adverse cardiovascular and cerebrovascular event (MACCE)

defined as a composite of all-cause death, non-fatal myocardial infarction, unplanned ischemia-driven revascularization, and stroke

Time frame
at 1 year after randomization

Secondary outcomes

1

Major adverse cardiovascular and cerebrovascular event (MACCE)

defined as a composite of all-cause death, non-fatal myocardial infarction, unplanned ischemia-driven revascularization, and stroke

Time frame
1 month, 6 months, 2 years, 3 years after randomization
2

All-cause death

cardiovascular, non-cardiovascular, death of undetermined cause

Time frame
1 month, 6 months, 1 year, 2 years, 3 years after randomization
3

Cardiac death

Time frame
1 month, 6 months, 1 year, 2 years, 3 years after randomization
4

Myocardial infarction

target vessel related, non-target vessel related

Time frame
1 month, 6 months, 1 year, 2 years, 3 years after randomization

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

RenJi Hospital

Lead sponsor

People's Hospital of Xinjiang Uygur Autonomous Region

Collaborator

LanZhou University

Collaborator

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