PROCTOR
Research type
Research Study
Full title
PeRcutaneous cOronary intervention of native Coronary arTery versus venous bypass graft in patients with prior cORonary artery bypass graft surgery – the PROCTOR trial
IRAS ID
253662
Contact name
James Spratt
Contact email
Sponsor organisation
Department of Cardiology, VU University Medical Center
Clinicaltrials.gov Identifier
Duration of Study in the UK
5 years, 9 months, 1 days
Research summary
All patients with a significant stenosis (>50% on coronary angiography) in a venous bypass graft discussed in the local heart team for revascularization will be screened for potential inclusion in the study. Patients will be eligible for inclusion if revascularization is deemed clinically indicated and technically feasible by the local heart team. The indication for revascularization will be based on symptoms and evidence of ischemia and viability in the
target vessel territory.(21) The lesion in the native vessel must be bypassed by a single venous graft or must be connected to a jump graft at the most distal anastomosis of that graft. In jump grafts, the lesion must be located distally to the second-to-last anastomosis. In case both the lesion in the native vessel and the lesion in the graft are deemed technically feasible for PCI, patients will be eligible for inclusion in the randomized study after consideration of in- and exclusion criteria. Patients who do not meet these criteria or decline
to participate in the randomized study will be approached for inclusion in the registry.
Subsequently patients will be approached for study participation. After being informed, patients will have at least 24 hours to consider participation. An independent physician will be available for extra information, if desired.
After obtaining written informed consent, patients will be randomized to either native vessel PCI or PCI of the venous bypass graft. Randomization will be performed using an interactive Web-based randomization system, Castor EDC. After 1 and 5 years, follow-up will be performed by means of a telephonic visit. After 3 years patients will be admitted to undergo a control invasive angiography.REC name
North West - Liverpool Central Research Ethics Committee
REC reference
19/NW/0195
Date of REC Opinion
20 Sep 2019
REC opinion
Further Information Favourable Opinion