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Ffr-gUidance for compLete Non-cuLprit REVASCularization (FULL REVASC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02862119
Recruitment Status : Active, not recruiting
First Posted : August 10, 2016
Last Update Posted : October 14, 2021
Sponsor:
Collaborators:
Uppsala University
The Swedish Research Council
Swedish Heart Lung Foundation
Abbott
Boston Scientific Corporation
Information provided by (Responsible Party):
Felix Bohm, Karolinska University Hospital

Brief Summary:

Background: The best strategy for ST-elevation myocardial infarction (STEMI) patients with multi-vessel disease, who undergo primary percutaneous coronary intervention (PCI) of the infarct-related artery (IRA) in the acute phase with remaining multivessel disease, is still not well established. Current guidelines recommend PCI of only the infarct related artery (IRA). However, recent small scale randomised controlled trials indicate that full revascularization of these non-infarct related arteries during the index procedure is superior to initial conservative treatment. Fractional flow reserve (FFR), a method used to determine ischemia-inducing lesions, has been shown to be superior to angiography-guided PCI in stable angina.

Objective and methods: To test the hypothesis that a strategy of systematic complete revascularization with FFR-guided PCI following STEMI/very high risk NSTEMI leads to improved clinical outcomes at one year compared to initial conservative management of non-culprit lesions. The trial is a prospective international multicentre registry-based randomized controlled trial with combined primary endpoint of all-cause mortality and non-fatal MI at one year. Key secondary endpoint is unplanned revascularization. 1545 patients with acute STEMI/very high risk NSTEMI with multi-vessel disease in Sweden, Denmark, Serbia, Finland, Latvia, Australia and New Zealand will be randomized into 2 arms:

  1. FFR-guided PCI of non-culprit lesions during index hospital admission or
  2. Initial conservative management following acute PCI of the culprit lesion(s) or

Randomization and data collection in the registries - the Swedish Coronary Angiography and Angioplasty Registry (SCAAR) and corresponding registries in other countries (or electronic data capture) - will ensure low bias, high inclusion rate and excellent follow-up of events at a low cost. Adjudication of clinical events and collection of data from other registries including death cause registries is also planned.

Significance: If this study shows that FFR-guided PCI of non-culprit lesions in STEMI/very high risk NSTEMI improves clinical outcome compared to conventional management this will change practise in how we should best manage these patients. Therefore a study of this size will definitely be of great importance in determining future guidelines for this large patient group to reduce both morbidity and mortality.


Condition or disease Intervention/treatment Phase
Coronary Artery Disease ST-elevation Myocardial Infarction Procedure: FFR Treatment Arm Other: Conservative Treatment Arm Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4052 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ffr-gUidance for compLete Non-cuLprit REVASCularization - a Registry-based Randomized Clinical Trial
Study Start Date : August 2016
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : June 2030

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arm Intervention/treatment
Experimental: FFR Treatment Arm

Following PCI of the infarct related artery it is up to the PCI operator to perform FFR-guided PCI of non-infarct related lesion(s) during the index procedure or later during the index hospital admission. For stenosis grade 90-99% FFR is not mandatory (but recommended). An FFR value of ≤0.80 is to be considered significant for ischemia with a recommendation that non-culprit PCI is performed. It is up to the operator to decide whether to use intra-venous or intracoronary adenosine during FFR. An FFR of >0.80 is to be considered non-significant for ischemia with a recommendation that medical management is pursued.

Pressure wires: Only Fractional Flow Reserve pressure wires from St Jude Medical or Boston Scientific can be used in this study.

Procedure: FFR Treatment Arm
Fractional Flow Reserve-guided PCI of non-culprit lesions during index hospital admission

Active Comparator: Conservative Treatment Arm
Only the infarct-related artery will be treated with PCI in this treatment arm during the index hospital admission. Medical therapy for angina pectoris is at the investigators discretion. Clinical follow-up of symptoms is recommended, but it is also acceptable to make a plan at hospital discharge for a later outpatient non-invasive stress-test. It is not acceptable to plan for an elective PCI in this treatment arm without signs of ischemia or symptoms.
Other: Conservative Treatment Arm
Initial Conservative management of non-culprit lesions during index hospital admission




Primary Outcome Measures :
  1. Combined endpoint of all-cause mortality and myocardial infarction [ Time Frame: 1 year ]
    Combined endpoint of all-cause mortality and myocardial infarction during follow-up of minimum 1 year (all events when the last patient has been followed for 1 year).


Secondary Outcome Measures :
  1. Number of patients with unplanned revascularization (PCI/CABG) of the coronary arteries [ Time Frame: 1 year ]
    Key Secondary Endpoint is unplanned revascularization (PCI/CABG) during follow-up of minimum 1 year (all events when the last patient has been followed for 1 year). All revascularizations will be adjudicated.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

The following specific criteria must be fulfilled:

  1. Symptoms indicating acute myocardial ischemia with a duration >30 min and occurring ≤ 24 h prior to randomization or presentation.
  2. One of the following:

    1. STEMI: ST elevation above the J-point of ≥0.1 millivolt in ≥ two contiguous leads or left bundle branch block
    2. Rescue PCI
    3. Risk evaluation following successful thrombolysis
    4. Very high risk NSTEMI: dynamic ECG changes or ongoing chest pain or acute heart failure or hemodynamic instability independent of ECG changes or life-threatening ventricular arrhythmias.
  3. PCI performed of infarct-related artery.
  4. One or more non-culprit lesions at least 2.5 mm on angiogram (visually assessed as 50-99%) amenable for PCI.
  5. Age >18 years.
  6. Ability to provide informed consent.

Exclusion Criteria:

  1. Previous CABG.
  2. Left main disease of >50% stenosis requiring intervention.
  3. Cardiogenic shock necessitating therapy in addition to revascularization. (LV support device or vasopressors).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02862119


Locations
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Sweden
Karolinska University Hospital
Stockholm, Sweden, S-171 76
Sponsors and Collaborators
Felix Bohm
Uppsala University
The Swedish Research Council
Swedish Heart Lung Foundation
Abbott
Boston Scientific Corporation
Investigators
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Principal Investigator: Felix Bohm, MD, PhD Karolinska Institutet
Study Chair: Stefan James, Professor Uppsala University, Sweden
Study Director: Andreas Rück, MD, PhD Karolinska University Hospital
Study Director: Eigil Fossum, MD, PhD OUS Ullevål, Oslo, Norway
Study Director: Thomas Engstrøm, MD, PhD Rigshospitalet, Denmark
Study Director: Thorarinn Gudnasson, MD, PhD Landspitali, Reykjavik, Iceland
Study Director: Mika Laine, MD, PhD Helsinki University Hospital, Finland
Study Director: Dariusz Dudek, Professor Krakow, Poland
Study Director: Andrejs Erglis, Professor Riga, Latvia
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Felix Bohm, MD, PhD, Interventional Cardiologist, Karolinska University Hospital
ClinicalTrials.gov Identifier: NCT02862119    
Other Study ID Numbers: FULL REVASC
First Posted: August 10, 2016    Key Record Dates
Last Update Posted: October 14, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data will be confidential. Only data on Group level will be presented in scientific publications.
Keywords provided by Felix Bohm, Karolinska University Hospital:
percutaneous coronary intervention
fractional flow reserve
all cause mortality
myocardial infarction
registry-based randomized clinical trial
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Infarction
ST Elevation Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases