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
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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NOT_YET_RECRUITING
NA
1904 participants
INTERVENTIONAL
2026-02-28
2031-02-28
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Immediate Complete Revascularization
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).
Staged Complete Revascularization
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.
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).
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.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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People's Hospital of Xinjiang Uygur Autonomous Region
OTHER
LanZhou University
OTHER
RenJi Hospital
OTHER
Responsible Party
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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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Other Identifiers
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FUTURE II
Identifier Type: -
Identifier Source: org_study_id
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