NL-OMON54561RecruitingPhase 3
PeRcutaneous cOronary intervention of native Coronary arTery versus venous bypass graft in patients with prior cORonary artery bypass graft surgery - the PROCTOR trial - PROCTOR trial
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Enrollment
- 240
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
Inclusion Criteria
- •1. A significant stenosis (>50% on angiography) in a venous bypass graft
- •2. Clinical indication for revascularization as determined by the local heart
- •team (based on symptoms, documented ischemia, and viability)
- •3. Both the native coronary artery lesion(s) and the sapheneous vein graft
- •lesion(s) must be deemed technically feasible for PCI by the Heart Team.
Exclusion Criteria
- •< 18 years of age
- •Target vessel diameter < 2.5 mm
- •Graft diameter > 5.5 mm
- •CABG performed less than 1 year prior to inclusion
- •Aneurysm formation in the bypass graft
- •Heavy burden of thrombus in the bypass graft (>50% of the bypass graft lumen
- •in >=2 out of 3 of the proximal, middle or distal third of the bypass graft).
- •STEMI at presentation
- •NSTEMI patients with ongoing ischemia
- •Cardiogenic shock
- •Pregnancy
- •Estimated life expectancy < 3 year
- •Failure to provide informed consent
Investigators
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