NCT05532631Recruiting
Percutaneous Coronary RevascularizatiOn VERsus Coronary-Artery Bypass Grafting for Multivessel Disease in Patients With Left Ventricular Dysfunction (PROVERB)
Source: ClinicalTrials.gov · Last updated 22 Mar 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
A short description, 5000 characters Ischemic cardiomyopathy related to coronary artery disease is currently the leading cause of heart failure. When it is responsible for heart failure, the coronary artery disease likely involves 2 or 3 vessels. Percutaneous coronary angioplasty, which is the other available technique for coronary revascularization, has never been evaluated in this indication. The results of retrospective registries studying the strategy for multivessel revascularization in patients with heart failure are inconsistent and no randomized study has been performed so far. Currently, ESC guidelines recommends to perform coronary-artery bypass grafting (IB) or percutaneous coronary intervention (IIa C) with the acknowledgement that percutaneous coronary intervention has never been properly evaluated in this setting. However, it has been previously demonstrated that left ventricle dysfunction significantly increases mortality and morbidity during and after cardiac surgery (3-10% mortality when LVEF is ≤30%). Moreover, the technical progresses in stent development and manufacturing have led to a dramatic decrease in the incidence of stent thrombosis and in-stent restenosis. Therefore, we hypothesize that percutaneous coronary angioplasty may be an attractive strategy for revascularization in patients with multi-vessel disease and left ventricle dysfunction, who are at high risk of surgical complication. Thus, we aim to test the hypothesis that percutaneous coronary intervention is non-inferior to coronary-artery bypass grafting for revascularization in patients with multivessel disease and left ventricle dysfunction. The main objective is to demonstrate that percutaneous coronary angioplasty is non-inferior to coronary-artery bypass grafting for multivessel revascularization in patients with left ventricular dysfunction on major cardiac and cerebrovascular events (MACCE). Method:A Prospective Randomized Open label, Blinded Endpoint, parallel-group, active controlled, non-inferiority, multicenter trial.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 1040 (estimated)
- First submitted
- 24 Jan 2022
- Start date
- 16 Mar 2023
- Primary completion date
- 16 Jul 2030
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Diseases
- Heart failure
- NCT number
- NCT05532631
What you commit to
- Study type: Interventional
- Planned participants: 1040
- From 16 Mar 2023 to the primary completion date, 16 Jul 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior:
- PCI of any coronary artery lesions within 6 months prior to randomization
- CABG at any time prior to randomization
- Current participation in other investigational drug or device studies
Other illness
- Contra indication for PCI or CABG determined by the heart team
- Indication for another cardiac surgery (i.e. valvular surgery, aortic repair…) if CABG is performed
- ST elevation myocardial infarction \< 30 days
- Non-cardiac illness with a life expectancy of less than 24 months
Other
- Ongoing cardiogenic shock at the time of coronary angiogram (SBP\< 90 mmHg with clinical signs of low output or patients requiring inotropic agents)
- Women who are pregnant or nursing
- Females of childbearing potential without effective method of birth control
- Patients who are under tutorship or curatorship
- Patient on AME (state medical aid)
Who the study is looking for
- Age ≥18 years
- Left ventricle ejection fraction ≤35% measured by echocardiography, cardiac magnetic resonance imaging ventriculogram or gated Single Photon Emission Computed Tomography ventriculogram
- Multivessel disease suitable for revascularization:
- Three vessel disease
- Two vessel disease involving left main or proximal left anterior descending artery
- Clinical and anatomic eligibility for both percutaneous coronary intervention (PCI) and Coronary artery bypass grafting (CABG) as agreed to by the local Heart Team (interventionalist determines PCI appropriateness and eligibility; cardiac surgeon determines surgical appropriateness and eligibility)
- Ability to sign informed consent and comply with all study procedures, including follow-up for at least two years
- Affiliation to health insurance
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Assistance Publique - Hopitaux de Paris - CHU Henri Mondor Coordinator of this site? Confirm its status | Créteil | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.