Status:
COMPLETED
Comparison Between FFR Guided Revascularization Versus Conventional Strategy in Acute STEMI Patients With MVD.
Lead Sponsor:
Maasstad Hospital
Collaborating Sponsors:
Abbott Medical Devices
Conditions:
Myocardial Infarction
Multivessel Coronary Artery Disease
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
The Compare-Acute trial is a prospective randomised trial in patients with multivessel disease, who are admitted into hospital with a ST-elevation Myocardial Infarction. The purpose of the study is to...
Detailed Description
Background of the study: At the moment the general opinion is divided over the way the non culprit lesions in patients presenting with STEMI should be treated. While the previous guidelines stead that...
Eligibility Criteria
Inclusion
- All patients between 18-85 years presenting with STEMI who will be treated with primary PCI in \< 12 h after the onset of symptoms\* 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.
- Patients with symptoms for more than 12 hr but ongoing angina complaints can be randomised
Exclusion
- Left main stem disease (stenosis \> 50%)
- STEMI due to in-stent thrombosis
- Chronic total occlusion of a non-IRA
- Severe stenosis with TIMI flow ≤ II of the non-IRA artery.
- Non-IRA stenosis not amenable for PCI treatment (operators decision)
- Complicated IRA treatment, with one or more of the following;
- Extravasation,
- Permanent no re-flow after IRA treatment (TIMI flow 0-1),
- Inability to implant a stent
- Known severe cardiac valve dysfunction that will require surgery in the follow-up period.
- Killip class III or IV already at presentation or at the completion of culprit lesion treatment.
- Life expectancy of \< 2 years.
- Intolerance to Aspirin, Clopidogrel, Prasugrel, Ticagrelor, Heparin, Bivaluridin, or Everolimus and known true anaphylaxis to prior contrast media of bleeding diathesis or known coagulopathy.
- 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 or planning to become pregnant any time after enrolment into this study.
- Inability to obtain informed consent.
- Expected lost to follow-up.
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2018
Estimated Enrollment :
885 Patients enrolled
Trial Details
Trial ID
NCT01399736
Start Date
July 1 2011
End Date
October 31 2018
Last Update
August 11 2020
Active Locations (26)
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1
University Hospital BRNO
Brno, Czechia
2
University Hospital Hradec Králové
Hradec Králové, Czechia
3
Liberec Regional Hospital
Liberec, Czechia
4
Herz-Zentrum Bad Krozingen
Bad Krozingen, Germany, 79189