PeRcutaneous cOronary intervention of native Coronary arTery versus venous bypass graft in patients with prior cORonary artery bypass graft surgery - the PROCTOR trial

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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON54561

Enrollment

240

Registered

2018-06-18

Start date

2018-12-28

Completion date

Unknown

Last updated

2025-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

arteriosclerosis coronary artery disease

Interventions

&nbsp

After inclusion, patients will be randomized to either PCI of the native vessel&nbsp

or PCI of the venous bypass graft in a 1:1 fashion.&nbsp

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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 

Design outcomes

Primary

Measure	Time frame
A 3-year composite of major adverse cardiac events (MACE: all-cause mortality, non-fatal target coronary territory myocardial infarction [MI], or clinically driven target coronary territory revascularization).	—

Secondary

Measure	Time frame
• The same composite endpoint at 1 and 5 year follow-up • All individual components of the primary endpoint at 1, 3 and 5 year follow-up • Renal failure requiring renal-replacement therapy • Target lesion revascularization at 1, 3 and 5 year follow-up • Target vessel failure at 1, 3 and 5 year follow-up • Non-fatal myocardial infarction >48 hours after PCI • PCI-related myocardial infarction • Angiographic outcome at 3-year follow up: o Late lumen loss at 3-year angiographic follow-up o In-stent binary restenosis (>=50%) at 3-year angiographic follow-up o In-stent re-occlusion at 3-year angiographic follow-up o Delta in-stent diameter stenosis at 3-year angiographic follow-up • Quality of life after 3 years: Delta SAQ, CCS and RDS scores at 3-year follow-up	—

Measure

Time frame

• The same composite endpoint at 1 and 5 year follow-up • All individual components of the primary endpoint at 1, 3 and 5 year follow-up • Renal failure requiring renal-replacement therapy • Target lesion revascularization at 1, 3 and 5 year follow-up • Target vessel failure at 1, 3 and 5 year follow-up • Non-fatal myocardial infarction >48 hours after PCI • PCI-related myocardial infarction • Angiographic outcome at 3-year follow up: o Late lumen loss at 3-year angiographic follow-up o In-stent binary restenosis (>=50%) at 3-year angiographic follow-up o In-stent re-occlusion at 3-year angiographic follow-up o Delta in-stent diameter stenosis at 3-year angiographic follow-up • Quality of life after 3 years: Delta SAQ, CCS and RDS scores at 3-year follow-up

—

Countries

Belgium, Netherlands, Poland, United Kingdom

Contacts

Public ContactI Vegting

Amsterdam UMC

researchcardiologie@amsterdamumc.nl020-4444445

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)