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Coronary Artery DiseaseSLIMNCT03562572

FFR Driven Complete Revascularization Versus Usual Care in NSTEMI Patients and Multivessel Disease

A study testing Ischemia driven revascularization in people with Coronary Artery Disease and NSTEMI - Non-ST Segment Elevation MI, run by Zuyderland Medisch Centrum at 9 sites in 3 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

To compare FFR guided complete revascularization during the index procedure with usual care in non-STEMI patients with multivessel disease. Read more about this study

Who is it for?
Ages 18 to 85 years
What is being tested?
Ischemia driven revascularization
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
476 participants
Where
9 sitesin 3 countries
Study dates
7 Jun 2018to Jul 2027
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 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients aged between 18-85 years presenting with non-STEMI according to current guidelines, who will be treated with PCI of the culprit and have at least one stenosis of >50% in a non-IRA on QCA or visual estimation of baseline angiography and judged feasible for treatment with PCI by the operator.
  • Non-IRA stenosis amenable for PCI treatment (operator's decision)
  • Signed informed consent

Who cannot join

  • Left main disease (stenosis > 50%)
  • Chronic total occlusion of a non-IRA
  • Indication for or previous coronary artery bypass grafting
  • Uncertain culprit lesion
  • Complicated IRA treatment, e.g. extravasation, permanent no re-flow after IRA treatment (TIMI flow 0-1) and inability to implant a stent
  • Known severe cardiac valve dysfunction that will require surgery or TAVI in the follow-up period.
Show all 13Show fewer
  • Killip class III or IV during the completion of culprit lesion treatment.
  • Life expectancy of < 1 year.
  • Intolerance to Aspirin, Clopidogrel, Prasugrel, Ticagrelor or Heparin.
  • Gastrointestinal or genitourinary bleeding within the prior 3 months.
  • Planned elective surgical procedure necessitating interruption of thienopyridines during the first 6 months post enrolment.
  • Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
  • Pregnancy

Trial locations and contacts

9 sites in 3 countries.

9 sites in 3 countries

Netherlands5 sites

  • Jeroen Bosch Ziekenhuis

    's-Hertogenbosch

  • Zuyderland MC

    Heerlen

  • Maastricht University Medical Centre

    Maastricht

  • Radboud University Medical Centre

    Nijmegen

  • Viecuri Medisch Centrum

    Venlo

Other trials in Netherlands

Hungary3 sites

  • Gottsegen György Országos Kardiológiai Intézet

    Budapest

  • Bacs-Kiskun Teaching Hospital

    Kecskemét

  • Szeged University

    Szeged

Other trials in Hungary

Czechia1 site

  • Brno University Hospital

    Brno

Other trials in Czechia

About this study

Official title: Ischemia (FFR) Driven Complete Revascularization Versus Usual Care in Patients With Non-ST Elevation Myocardial Infarction and Multivessel Diseases: The South Limburg Myocardial Infarction Study Group The SLIM Study

To compare FFR guided complete revascularization during the index procedure with usual care in non-STEMI patients with multivessel disease.

Read the detailed description

Background:

Patients with non-ST elevation myocardial infarction (non-STEMI), as compared with STEMI patients, have a higher risk profile, more often MVD and less favourable outcome. Recent studies showed that complete revascularization in STEMI patients is feasible and effective. However, there is no clear evidence regarding the role of complete coronary revascularization by PCI in patients with non-STEMI with MVD.

Objective:

To compare FFR guided complete revascularization during the index procedure with usual care in non-STEMI patients with multivessel disease.

Design:

Prospective, multicentre, 1:1 randomized, investigator initiated study.

Hypothesis:

FFR guided complete percutaneous revascularisation of all significant stenosis in the non-culprit lesion performed within the index PCI procedure will improve clinical outcomes compared to the usual care, guided by discretion of the physician.

Being tested
Ischemia driven revascularization, Usual care group
Medical subject headings
Coronary Artery Disease, Non-ST Elevated Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ischemia driven revascularizationProcedure or surgery

    In the ischemia driven complete revascularisation strategy group all flow limiting (FFR ≤ 0.80) lesions will receive treatment by PCI and stenting during the index intervention

  • Usual care groupOther

    In the randomised to usual care group the procedure will stop after the PCI of the culprit artery and the patient will be referred to his treating cardiologist and/ or heart team who will decide whether a staged PCI of the non- IRA artery should take place. If the treating cardiologist (after advise of the heart team) decides to perform the non-IRA PCI revascularisation, than such treatment should take place within six weeks from the primary PCI in order to count as a scheduled staged PCI procedure.

Study groups in NCT03562572
Study groupRoleWhat they receive
Ischemia driven revascularizationExperimentalIn the ischemia driven complete revascularisation strategy group all flow limiting (FFR ≤ 0.80) lesions will receive treatment by PCI and stenting. The non-IRA PCI should be performed during the same intervention. Exceptions can be made for complex lesions where the operator estimates that the revascularisation procedure will require significant contrast overload, which may lead to deterioration of cardiac and renal function of the patient.
Receives: Procedure: Ischemia driven revascularization
Usual care groupActive comparatorIn the randomised to usual care group the procedure will stop after the PCI of the culprit artery and the patient will be referred to his treating cardiologist and/ or heart team who will decide whether a staged PCI of the non- IRA artery should take place. If the treating cardiologist (after advise of the heart team) decides to perform the non-IRA PCI revascularisation, than such treatment should take place within six weeks from the primary PCI in order to count as a scheduled staged PCI procedure.
Receives: Other: Usual care group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The incidence of MACE at 12 months

    MACE = The composite endpoint of all cause death, non-fatal Myocardial Infarction, any revascularisation and stroke at 12 months.

    Measured: 12 months

Secondary outcomes (9)

  1. The incidence of MACE in subgroups at 12 and 24 months.

    Prespecified subgroup analyses of primary outcomes will be performed for:

    1. Diabetic patients versus non-diabetic patients
    2. Elderly (≥ 75 years) versus young patients (< 75 years)
    3. Male versus Female gender
    4. High versus low risk patients according to GRACE Risk Score
    5. Patients previous myocardial infarction versus patients with no previous myocardial infarction

    The Global Registry of Acute Coronary Events (GRACE) score estimates the admission 6 month mortality for patients with acute coronary syndrome. The GRACE score ranges from 0 to > 285. A higher GRACE represents a higher mortality risk, ranging from 0-2% when the GRACE is between 0 and 87, to 99% when the GRACE exceeds 285.

    Measured: 12 and 24 months

  2. Composite endpoint of Net Adverse Clinical Events (NACE) defined as composite endpoint of Cardiac death, Myocardial Infarction, any Revascularisation, Stroke and major bleeding at 12, 24 and 36 months.

    Measured: 12, 24 and 36 months

  3. Composite endpoint hospitalisation for heart failure and unstable angina pectoris at 12, 24 and 36 months.

    Measured: 12, 24 and 36 months

  4. All-cause mortality or Myocardial infarction at 12, 24 and 36 months.

    Measured: 12, 24 and 36 months

  5. Any revascularisation at 12, 24 and 36 months.

    Measured: 12, 24 and 36 months

  6. Stent thrombosis at 12, 24 and 36 months.

    Measured: 12, 24 and 36 months

  7. Bleeding (major and minor) at 48 hours and 12 months.

    Measured: 48 hours and 12 months

  8. The incidence of MACE at 36 months as well as outcomes of each component of MACE at 12 and 24 and 36 months.

    MACE = The composite endpoint of all cause death, non-fatal Myocardial Infarction, any revascularisation and stroke at 12 months.

    Measured: 12, 24 and 36 months

  9. Left ventricular ejection fraction at 12 and 24 and 36 month (MIBI scan, MRI or Echocardiography).

    Measured: 12, 24 and 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jun 2018
  2. Study start7 Jun 2018
  3. Primary completion21 Jul 2025
  4. Study completionJul 2027 (estimated)

Resources

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
Model description
It concerns an investigator initiated prospective 1:1 randomised clinical trial in non-STEMI patients with multivessel coronary artery disease amenable to treatment with PCI.
Masking
None (open label)
Enrolment
476 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03562572
Sponsor's protocol ID
17-T-142
Other IDs
28708
Acronym
SLIM
Status last verified
Aug 2025
First submitted
23 May 2018
Last updated
15 Aug 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Pustjens TFS, Veenstra L, Camaro C, Ruiters AW, Lux A, Ruzsa Z, Piroth Z, Ilhan M, Vainer J, Gho B, Winkler PJC, Stein M, Theunissen RALJ, Kala P, Polad J, Berta B, Gabrio A, van Royen N, van 't Hof AWJ, Rasoul S. Fractional Flow Reserve-Guided Complete vs Culprit-Only Revascularization in Non-ST-Elevation Myocardial Infarction and Multivessel Disease: The SLIM Randomized Clinical Trial. JAMA. 2025 Nov 11;334(18):1628-1637. doi: 10.1001/jama.2025.16189.

    PubMed 40886310

Questions about this trial

What is this clinical trial studying?

A study testing Ischemia driven revascularization in people with Coronary Artery Disease and NSTEMI - Non-ST Segment Elevation MI, run by Zuyderland Medisch Centrum at 9 sites in 3 countries.

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 3 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: under way, not looking for participants, as of the sponsor's last update on 15 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Netherlands, Hungary, Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The incidence of MACE at 12 months (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03562572, which also lists 1 linked publication.

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 15 Aug 2025; AzTrials last refreshed its copy on 1 Nov 2026.

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