Status:
ACTIVE_NOT_RECRUITING
PeRcutaneous cOronary Intervention of Native Coronary arTery Versus Venous Bypass Graft in Patients With Prior CABG
Lead Sponsor:
Amsterdam UMC, location VUmc
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Multi-centre, randomised clinical trial with anticipated 17 European centres: in the Netherlands, Belgium, Germany and UK. Patients with a dysfunctional bypass graft with a clinical indication for rev...
Detailed Description
Multi-centre, randomised clinical trial with anticipated 17 European centres: in the Netherlands, Belgium, Germany and UK. Patients with a dysfunctional bypass graft with a clinical indication for rev...
Eligibility Criteria
Inclusion
- A significant stenosis (\>50% on angiography) in a venous bypass graft
- The native lesion must be bypassed by a single graft or must be connected to a jump graft at the most distal anastomosis of that graft
- In jumpgraft lesions, the lesion must be located distally to the second-to-last anastomosis
- Clinical indication for revascularization as determined by the local heart team (based on symptoms, documented ischemia, and viability).
- Both the native lesion and the venous graft lesion must be deemed suitable for PCI with a commercially available second generation DES.
- Informed consent must be obtained
Exclusion
- \< 18 years of age
- Target vessel diameter \< 2.5 mm
- CABG performed less than 1 year prior to inclusion
- Diameter of the graft \> 5.5 mm
- 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
- Severe kidney disease defined as an eGFR \< 30 ml/min.
- Pregnancy
- Estimated life expectancy \< 3 year
- Contraindications to PCI
Key Trial Info
Start Date :
January 22 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2028
Estimated Enrollment :
221 Patients enrolled
Trial Details
Trial ID
NCT03805048
Start Date
January 22 2019
End Date
June 30 2028
Last Update
February 13 2025
Active Locations (21)
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1
University Hospital
Antwerp, Edegem, Belgium, B 2650
2
Ziekenhuis Netwerk Antwerpen (ZNA) Middelheim
Antwerp, Belgium, 2020
3
Ziekenhuis Oost-Limburg
Genk, Belgium, B-3600
4
UZ Leuven
Leuven, Belgium, 3000