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.

Study Overview

• Status: Not yet recruiting
• Conditions: NSTEMI - Non-ST Segment Elevation MI; NSTEMI; NSTE-ACS (NSTEMI and UA); Non-ST-elevation Acute Coronary Syndrome
• Intervention / Treatment: Device: Immediate Complete Revascularization; Device: Staged Complete Revascularization

• Study Type: Interventional
• Enrollment (Estimated): 1904
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jun Pu, MD, PhD; Phone Number: 86-21-68383477; Email: pujun310@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Immediate Complete Revascularization	Device: 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).
Active Comparator: Staged Complete Revascularization	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1 month, 6 months, 2 years, 3 years after randomization
All-cause death	cardiovascular, non-cardiovascular, death of undetermined cause	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	target vessel related, non-target vessel related	1 month, 6 months, 1 year, 2 years, 3 years after randomization
Target vessel revascularization	ischemia-driven, non-ischemia-driven	1 month, 6 months, 1 year, 2 years, 3 years after randomization
Any coronary revascularization	ischemia-driven, non-ischemia-driven	1 month, 6 months, 1 year, 2 years, 3 years after randomization
ARC-2 defined stent thrombosis	including confirmed and possible stent thrombosis in acute, subacute, and late time frames	1 month, 6 months, 1 year, 2 years, 3 years after randomization
Stroke	ischaemia, hemorrhage	1 month, 6 months, 1 year, 2 years, 3 years after randomization
Contrast agent-related acute kidney injury		1 month after randomization
Major bleeding	BARC grades 3 and 5	1 month, 6 months, 1 year, 2 years, 3 years after randomization

Collaborators and Investigators

• Sponsor: RenJi Hospital
• Collaborators: LanZhou University; People's Hospital of Xinjiang Uygur Autonomous Region
• Investigators: 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

Study record dates

Study Major Dates

• Study Start (Estimated): February 28, 2026
• Primary Completion (Estimated): February 28, 2029
• Study Completion (Estimated): February 28, 2031

Study Registration Dates

• First Submitted: January 6, 2026
• First Submitted That Met QC Criteria: January 6, 2026
• First Posted (Actual): January 15, 2026

Study Record Updates

• Last Update Posted (Actual): January 30, 2026
• Last Update Submitted That Met QC Criteria: January 28, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: NSTEMI; FUTURE II
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Infarction; Necrosis; Myocardial Ischemia; Myocardial Infarction; Ischemia; Pathological Conditions, Signs and Symptoms; Non-ST Elevated Myocardial Infarction
• Other Study ID Numbers: FUTURE II

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Data sharing will be available from 12 months after the publication of the main results.
• IPD Sharing Access Criteria: 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.; The Custodian of the Collection will not consider any Proposals for data sharing that unblind, or potentially unblind, randomised comparisons in active / ongoing trials.; 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.; 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.; The Requesters must not have a conflict of interest that may potentially influence their interpretation of any analyses.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No