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NCT03805048Active, not recruiting

PeRcutaneous cOronary Intervention of Native Coronary arTery Versus Venous Bypass Graft in Patients With Prior CABG

PeRcutaneous cOronary Intervention of Native Coronary arTery Versus Venous Bypass Graft in Patients With Prior cORonary Artery Bypass Graft Surgery - the PROCTOR Trial

Source: ClinicalTrials.gov · Last updated 13 Feb 2025

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
221 (actual)
First submitted
7 Jan 2019
Start date
22 Jan 2019
Primary completion date
31 Jan 2028
Lead sponsor
Amsterdam UMC, location VUmc
NCT number
NCT03805048

What you commit to

  • Study type: Interventional
  • Participants enrolled: 221
  • From 22 Jan 2019 to the primary completion date, 31 Jan 2028
  • 21 sites in 5 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • CABG performed less than 1 year prior to inclusion

Lab values

  • Severe kidney disease defined as an eGFR \< 30 ml/min.

Age

  • \< 18 years of age

Other

  • Target vessel diameter \< 2.5 mm
  • Diameter of the graft \> 5.5 mm
  • 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
  • Contraindications to PCI

Who the study is looking for

  • A significant stenosis (\>50% on angiography) in a venous bypass graft
    • The native lesion must be bypassed by a single graft or must be connected to a jump graft at the most distal anastomosis of that graft
    • In jumpgraft lesions, the lesion must be located distally to the second-to-last anastomosis
  • Clinical indication for revascularization as determined by the local heart team (based on symptoms, documented ischemia, and viability).
  • Both the native lesion and the venous graft lesion must be deemed suitable for PCI with a commercially available second generation DES.
  • Informed consent must be obtained

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (21)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Ziekenhuis Netwerk Antwerpen (ZNA) Middelheim
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AntwerpBelgiumUnknown status
University Hospital
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AntwerpBelgiumUnknown status
Ziekenhuis Oost-Limburg
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GenkBelgiumUnknown status
UZ Leuven
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LeuvenBelgiumUnknown status
Universitäts Herzzentrum
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Bad KrozingenGermanyUnknown status
Basildon & Thurrock University Hospitals (Essex CTC)
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BasildonUnited KingdomUnknown status
Health and Social Care Trust
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BelfastUnited KingdomUnknown status
The Royal Bournemouth & Christchurch Hospitals NHS Foundation Trust
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BournemouthUnited KingdomUnknown status
UH Bristol NHS Trust, Bristol Heart Institute
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BristolUnited KingdomUnknown status
Golden Jubilee National Hospital
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GlasgowUnited KingdomUnknown status
St. George's University Hospitals NHS Foundation Trust
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LondonUnited KingdomUnknown status
Manchester University NHS Foundation Trust, Wythenshawe Hospital
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ManchesterUnited KingdomUnknown status
Universitair Medische Centra
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AmsterdamNetherlandsUnknown status
Academic Medical Center
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AmsterdamNetherlandsUnknown status
Amphia Ziekenhuis
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BredaNetherlandsUnknown status
Catharina Ziekenhuis
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EindhovenNetherlandsUnknown status
Medisch Centrum Leeuwarden
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LeeuwardenNetherlandsUnknown status
Sint Antonius Ziekenhuis
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NieuwegeinNetherlandsUnknown status
Radboud Universitair Medisch Centrum (Radboud UMC)
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NijmegenNetherlandsUnknown status
Universitair Medisch Centrum
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UtrechtNetherlandsUnknown status
Narodowy Instytut Kardiologii Stefana Kardynała Wyszyńskiego Państwowy Instytut Badawczy
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WarsawPolandUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.