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

NCT ID: NCT07343076

Last Updated: 2026-01-30

Study Results

Results pending

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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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

1904 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-02-28

Study Completion Date

2031-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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NSTEMI NSTEMI - Non-ST Segment Elevation MI Non-ST-elevation Acute Coronary Syndrome NSTE-ACS (NSTEMI and UA)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Immediate Complete Revascularization

Group Type EXPERIMENTAL

Immediate Complete Revascularization

Intervention Type 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

Group Type ACTIVE_COMPARATOR

Staged Complete Revascularization

Intervention Type 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.

Interventions

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Immediate Complete Revascularization

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).

Intervention Type DEVICE

Staged Complete Revascularization

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Age: 18 years or older.
2. 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.
3. PCI within 72 hours of diagnosis.
4. 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.
5. Sign an informed consent form before participating in the study.

Exclusion Criteria

1. Have received thrombolytic treatment.
2. Cardiogenic shock or SBP\< 90 mmHg.
3. Patients in whom the culprit vessel cannot be clearly identified.
4. 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.
5. Previous PCI within the past 1 month or previous coronary artery bypass graft (CABG).
6. Accompanied by other diseases that lead to an expected survival time of ≤ 12 months.
7. Patients with other serious diseases such as severe renal insufficiency (creatinine clearance value \<30ml/min), hepatic insufficiency, thrombocytopenia (≤50\*109/L).
8. Patients with severe valvular disease, hypertrophic cardiomyopathy, restrictive cardiomyopathy, and primary pulmonary hypertension.
9. Not suitable for clinical study:

1. Have enrolled in the other clinical studies that may affect the outcome assessment of this study.
2. Pregnant and lactating women.
3. Known allergy to the drugs that may be used in the study.
4. Unable to comply with the trial protocol or follow-up requirements; or the investigator believes that participation in the trial may put the patient at greater risk.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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People's Hospital of Xinjiang Uygur Autonomous Region

OTHER

Sponsor Role collaborator

LanZhou University

OTHER

Sponsor Role collaborator

RenJi Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jun Pu, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

RenJi Hospital

Yining Yang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

People's Hospital of Xinjiang Uygur Autonomous Region

Ming Bai, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

LanZhou University

Central Contacts

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Jun Pu, MD, PhD

Role: CONTACT

86-21-68383477

Other Identifiers

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FUTURE II

Identifier Type: -

Identifier Source: org_study_id

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