Efficacy of Immediate Versus Staged Complete Revascularization in Patients With NSTE-ACS and Multivessel Disease (FUTURE II)
1 other identifier
interventional
1,904
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2026
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 6, 2026
CompletedFirst Posted
Study publicly available on registry
January 15, 2026
CompletedStudy Start
First participant enrolled
February 28, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 28, 2031
January 30, 2026
January 1, 2026
3 years
January 6, 2026
January 28, 2026
Conditions
Keywords
Outcome Measures
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
at 1 year after randomization
Secondary Outcomes (10)
Major adverse cardiovascular and cerebrovascular event (MACCE)
1 month, 6 months, 2 years, 3 years after randomization
All-cause death
1 month, 6 months, 1 year, 2 years, 3 years after randomization
Cardiac death
1 month, 6 months, 1 year, 2 years, 3 years after randomization
Myocardial infarction
1 month, 6 months, 1 year, 2 years, 3 years after randomization
Target vessel revascularization
1 month, 6 months, 1 year, 2 years, 3 years after randomization
- +5 more secondary outcomes
Study Arms (2)
Immediate Complete Revascularization
EXPERIMENTALStaged Complete Revascularization
ACTIVE COMPARATORInterventions
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).
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
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- RenJi Hospitallead
- People's Hospital of Xinjiang Uygur Autonomous Regioncollaborator
- LanZhou Universitycollaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jun Pu, MD, PhD
RenJi Hospital
- PRINCIPAL INVESTIGATOR
Yining Yang, MD, PhD
People's Hospital of Xinjiang Uygur Autonomous Region
- PRINCIPAL INVESTIGATOR
Ming Bai, MD, PhD
LanZhou University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 6, 2026
First Posted
January 15, 2026
Study Start
February 28, 2026
Primary Completion (Estimated)
February 28, 2029
Study Completion (Estimated)
February 28, 2031
Last Updated
January 30, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Data sharing will be available from 12 months after the publication of the main results.
- Access Criteria
- 1. The data sharing will be only for the purposes of health and medical research and within the constraints of the consent under which the data were originally gathered. 2. The Custodian of the Collection will not consider any Proposals for data sharing that unblind, or potentially unblind, randomised comparisons in active / ongoing trials. 3. Requesters should be employees of a recognised academic institution, health service organisation, commercial research organisation or from the pharmaceutical industry. Requesters must have experience in medical research. 4. Requesters must be able to demonstrate through their peer review publications in the area of interest their ability to carry out the proposed use of the requested dataset from a Collection. 5. The Requesters must not have a conflict of interest that may potentially influence their interpretation of any analyses.
Bona fide researchers can request access to the data after the publication of the main results, provided that a study protocol is submitted to and approved by the FUTURE II Steering Committee.