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

Phase 3

Recruiting

Conditions: arteriosclerosis
coronary artery disease
10011082
10003216

Registration Number: NL-OMON54561

Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 240

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

• < 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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>A 3-year composite of major adverse cardiac events (MACE: all-cause mortality,<br /><br>non-fatal target coronary territory myocardial infarction [MI], or clinically<br /><br>driven target coronary territory revascularization).</p><br>

Secondary Outcome Measures

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