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

    james.spratt@nhs.net

  • Sponsor organisation

    Department of Cardiology, VU University Medical Center

  • Clinicaltrials.gov Identifier

    NCT03805048

  • 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