NSTEMINCT07343076
Efficacy of Immediate Versus Staged Complete Revascularization in Patients With NSTE-ACS and Multivessel Disease (FUTURE II)
A study testing Immediate Complete Revascularization and Staged Complete Revascularization in people with NSTEMI and NSTEMI - Non-ST Segment Elevation MI, run by RenJi Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSTEMI, NSTEMI - Non-ST Segment Elevation MI, Non-ST-elevation Acute Coronary Syndrome
- What is being tested?
- Immediate Complete Revascularization and Staged Complete Revascularization
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,904 participants
- Where
- No sites listed yet
- Study dates
- 28 Feb 2026to 28 Feb 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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:
Read more
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.
- Conditions
- NSTEMI, NSTEMI - Non-ST Segment Elevation MI, Non-ST-elevation Acute Coronary Syndrome, NSTE-ACS (NSTEMI and UA)
- Being tested
- Immediate Complete Revascularization, Staged Complete Revascularization
- Keywords
- NSTEMI, FUTURE II
- Medical subject headings
- Non-ST Elevated Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate Complete RevascularizationDevice
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 RevascularizationDevice
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 group | Role | What they receive |
|---|---|---|
| Immediate Complete Revascularization | Experimental | Not described Receives: Device: Immediate Complete Revascularization |
| Staged Complete Revascularization | Active comparator | Not described Receives: Device: Staged Complete Revascularization |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at 1 year after randomization
Secondary outcomes (10)
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
Measured: 1 month, 6 months, 2 years, 3 years after randomization
All-cause death
cardiovascular, non-cardiovascular, death of undetermined cause
Measured: 1 month, 6 months, 1 year, 2 years, 3 years after randomization
Cardiac death
Measured: 1 month, 6 months, 1 year, 2 years, 3 years after randomization
Myocardial infarction
target vessel related, non-target vessel related
Measured: 1 month, 6 months, 1 year, 2 years, 3 years after randomization
Target vessel revascularization
ischemia-driven, non-ischemia-driven
Measured: 1 month, 6 months, 1 year, 2 years, 3 years after randomization
Any coronary revascularization
ischemia-driven, non-ischemia-driven
Measured: 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
Measured: 1 month, 6 months, 1 year, 2 years, 3 years after randomization
Stroke
ischaemia, hemorrhage
Measured: 1 month, 6 months, 1 year, 2 years, 3 years after randomization
Contrast agent-related acute kidney injury
Measured: 1 month after randomization
Major bleeding
BARC grades 3 and 5
Measured: 1 month, 6 months, 1 year, 2 years, 3 years after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start28 Feb 2026 (estimated)
- Primary completion28 Feb 2029 (estimated)
- Study completion28 Feb 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSTEMIStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,904 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- People's Hospital of Xinjiang Uygur Autonomous Region, LanZhou University
- Responsible party
- Sponsor
- Investigators
- Jun Pu, MD, PhD, Principal investigator, RenJi HospitalYining Yang, MD, PhD, Principal investigator, People's Hospital of Xinjiang Uygur Autonomous RegionMing Bai, MD, PhD, Principal investigator, LanZhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07343076
- Sponsor's protocol ID
- FUTURE II
- Status last verified
- Jan 2026
- First submitted
- 6 Jan 2026
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Immediate Versus Staged Complete Revascularization in Patients With NSTE-ACS and Multivessel Disease (FUTURE II)
- ClinicalTrials.gov ID
- NCT07343076
- Acronym / sponsor ID
- FUTURE II
- Conditions
- NSTEMI, NSTEMI - Non-ST Segment Elevation MI, Non-ST-elevation Acute Coronary Syndrome, NSTE-ACS (NSTEMI and UA)
- Keywords
- NSTEMI, FUTURE II
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,904 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Collaborators
- People's Hospital of Xinjiang Uygur Autonomous Region, LanZhou University
- Study start
- 28 Feb 2026 (estimated)
- Primary completion
- 28 Feb 2029 (estimated)
- Study completion
- 28 Feb 2031 (estimated)
- First posted
- 15 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate Complete Revascularization | Experimental | Device: Immediate Complete Revascularization |
| Staged Complete Revascularization | Active comparator | Device: Staged Complete Revascularization |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (13 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immediate Complete RevascularizationImmediate 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). | Device | Immediate Complete Revascularization |
| Staged Complete RevascularizationDuring 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. | Device | Staged Complete Revascularization |
Primary outcome
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
10 secondary outcomes
Major adverse cardiovascular and cerebrovascular event (MACCE)
Time frame: 1 month, 6 months, 2 years, 3 years after randomization
All-cause death
Time frame: 1 month, 6 months, 1 year, 2 years, 3 years after randomization
Cardiac death
Time frame: 1 month, 6 months, 1 year, 2 years, 3 years after randomization
Myocardial infarction
Time frame: 1 month, 6 months, 1 year, 2 years, 3 years after randomization
Target vessel revascularization
Time frame: 1 month, 6 months, 1 year, 2 years, 3 years after randomization
Any coronary revascularization
Time frame: 1 month, 6 months, 1 year, 2 years, 3 years after randomization
ARC-2 defined stent thrombosis
Time frame: 1 month, 6 months, 1 year, 2 years, 3 years after randomization
Stroke
Time frame: 1 month, 6 months, 1 year, 2 years, 3 years after randomization
Contrast agent-related acute kidney injury
Time frame: 1 month after randomization
Major bleeding
Time frame: 1 month, 6 months, 1 year, 2 years, 3 years after randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jun Pu, MD, PhD principal investigator
RenJi Hospital
Yining Yang, MD, PhD principal investigator
People's Hospital of Xinjiang Uygur Autonomous Region
Ming Bai, MD, PhD principal investigator
LanZhou University
Questions about this trial
What is this clinical trial studying?
A study testing Immediate Complete Revascularization and Staged Complete Revascularization in people with NSTEMI and NSTEMI - Non-ST Segment Elevation MI, run by RenJi Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jun Pu, MD, PhD (86-21-68383477, pujun310@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major adverse cardiovascular and cerebrovascular event (MACCE) (time frame: at 1 year after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026.