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PeRcutaneous cOronary Intervention of Native Coronary arTery Versus Venous Bypass Graft in Patients With Prior CABG
Sponsor: Amsterdam UMC, location VUmc
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 revascularization will be randomized to either PCI of the native vessel or PCI of the dysfunctional venous bypass graft. 584 patients with a a clinical indication for percutaneous coronary intervention and a dysfunctional graft on the target vesselional venous bypass graft are planned to be enrolled during 3 years.Study objectives: to investigate the clinical and angiographic outcome of native vessel PCI compared to PCI of venous bypass graft in patients with a dysfunctional venous bypass graft with a clinical indication for revascularization. 1 year 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.The CT-substudy and the PROCTOR registry is planned to be conducted too.
Official title: PeRcutaneous cOronary Intervention of Native Coronary arTery Versus Venous Bypass Graft in Patients With Prior cORonary Artery Bypass Graft Surgery - the PROCTOR Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
221
Start Date
2019-01-22
Completion Date
2028-06-30
Last Updated
2025-02-13
Healthy Volunteers
No
Conditions
Interventions
Percutaneous coronary intervention
PCI of the bypass graft will be performed by current standards and at the discretion of the operator. Only commercially available second generation DES - XIENCE Sierra will be used. In case of a CTO lesion, the aforementioned hybrid approach will be applied.This approach uses several angiographic characteristics to guide strategical planning of the procedure, using 4 complementary techniques to cross a CTO: antegrade wire escalation, antegrade dissection reentry, retrograde wire escalation, retrograde dissection reentry. In case of PCI failure, a second attempt can be performed within 1 month. Patients will be hospitalized for a min. of 6-8 hours after PCI and receive DAPT prior to the procedure or triple therapy in case of indication for oral anticoagulation, their duration according to the current guidelines of the ESC for stable coronary disease or ACS.
Locations (21)
University Hospital
Antwerp, Edegem, Belgium
Ziekenhuis Netwerk Antwerpen (ZNA) Middelheim
Antwerp, Belgium
Ziekenhuis Oost-Limburg
Genk, Belgium
UZ Leuven
Leuven, Belgium
Universitäts Herzzentrum
Bad Krozingen, Germany
Universitair Medische Centra
Amsterdam, Netherlands
Academic Medical Center
Amsterdam, Netherlands
Amphia Ziekenhuis
Breda, Netherlands
Catharina Ziekenhuis
Eindhoven, Netherlands
Medisch Centrum Leeuwarden
Leeuwarden, Netherlands
Sint Antonius Ziekenhuis
Nieuwegein, Netherlands
Radboud Universitair Medisch Centrum (Radboud UMC)
Nijmegen, Netherlands
Universitair Medisch Centrum
Utrecht, Netherlands
Narodowy Instytut Kardiologii Stefana Kardynała Wyszyńskiego Państwowy Instytut Badawczy
Warsaw, Poland
Basildon & Thurrock University Hospitals (Essex CTC)
Basildon, United Kingdom
Health and Social Care Trust
Belfast, United Kingdom
The Royal Bournemouth & Christchurch Hospitals NHS Foundation Trust
Bournemouth, United Kingdom
UH Bristol NHS Trust, Bristol Heart Institute
Bristol, United Kingdom
Golden Jubilee National Hospital
Glasgow, United Kingdom
St George's University Hospitals NHS Foundation Trust
London, United Kingdom
Manchester University NHS Foundation Trust, Wythenshawe Hospital
Manchester, United Kingdom