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NCT Number: NCT07343076

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

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.

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Key information

Conditions

NSTEMI Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia NSTE-ACS (NSTEMI and UA) NSTEMI - Non-ST Segment Elevation MI Necrosis Non-ST Elevated Myocardial Infarction Non-ST-elevation Acute Coronary Syndrome Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • 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.
  • Not suitable for clinical study:
  • Have enrolled in the other clinical studies that may affect the outcome assessment of this study.
  • Pregnant and lactating women.
  • Known allergy to the drugs that may be used in the study.
  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Major adverse cardiovascular and cerebrovascular event (MACCE)

    Time frame: at 1 year after randomization

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

Secondary outcomes

  1. Major adverse cardiovascular and cerebrovascular event (MACCE)

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

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

  2. All-cause death

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

    cardiovascular, non-cardiovascular, death of undetermined cause

  3. Cardiac death

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

  4. Myocardial infarction

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

    target vessel related, non-target vessel related

  5. Target vessel revascularization

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

    ischemia-driven, non-ischemia-driven

  6. Any coronary revascularization

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

    ischemia-driven, non-ischemia-driven

  7. ARC-2 defined stent thrombosis

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

    including confirmed and possible stent thrombosis in acute, subacute, and late time frames

  8. Stroke

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

    ischaemia, hemorrhage

  9. Contrast agent-related acute kidney injury

    Time frame: 1 month after randomization

  10. Major bleeding

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

    BARC grades 3 and 5

Study contacts

Contact information is provided by the study sponsor or research team.

Jun Pu, MD, PhD

CONTACT

[email protected]

86-21-68383477

Sponsors and collaborators

Lead sponsor

RenJi Hospital

Other

Collaborators

  • LanZhou University
  • People's Hospital of Xinjiang Uygur Autonomous Region

Registry information

Important dates

Study start
2026
Primary completion
2029
Study completion
2031
First posted
Jan 15, 2026
Registry last updated
Jan 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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