Efficacy of Immediate Versus Staged Complete Revascularization in Patients With NSTE-ACS and Mult… (NCT07343076) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Efficacy of Immediate Versus Staged Complete Revascularization in Patients With NSTE-ACS and Multivessel Disease (FUTURE II)
1,904 participantsStarted 2026-02-28
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
✓. Sign an informed consent form before participating in the study.
Exclusion criteria
✕. Have received thrombolytic treatment.
✕. Cardiogenic shock or SBP\< 90 mmHg.
✕. Patients in whom the culprit vessel cannot be clearly identified.
✕
What they're measuring
1
Major adverse cardiovascular and cerebrovascular event (MACCE)
. 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.
✕. Previous PCI within the past 1 month or previous coronary artery bypass graft (CABG).
✕. Accompanied by other diseases that lead to an expected survival time of ≤ 12 months.
✕. Patients with other serious diseases such as severe renal insufficiency (creatinine clearance value \<30ml/min), hepatic insufficiency, thrombocytopenia (≤50\*109/L).
✕. Patients with severe valvular disease, hypertrophic cardiomyopathy, restrictive cardiomyopathy, and primary pulmonary hypertension.