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
- Diseases
- Coronary artery disease
- 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
Sites (21)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ziekenhuis Netwerk Antwerpen (ZNA) Middelheim Coordinator of this site? Confirm its status | Antwerp | Belgium | Unknown status |
| University Hospital Coordinator of this site? Confirm its status | Antwerp | Belgium | Unknown status |
| Ziekenhuis Oost-Limburg Coordinator of this site? Confirm its status | Genk | Belgium | Unknown status |
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Unknown status |
| Universitäts Herzzentrum Coordinator of this site? Confirm its status | Bad Krozingen | Germany | Unknown status |
| Basildon & Thurrock University Hospitals (Essex CTC) Coordinator of this site? Confirm its status | Basildon | United Kingdom | Unknown status |
| Health and Social Care Trust Coordinator of this site? Confirm its status | Belfast | United Kingdom | Unknown status |
| The Royal Bournemouth & Christchurch Hospitals NHS Foundation Trust Coordinator of this site? Confirm its status | Bournemouth | United Kingdom | Unknown status |
| UH Bristol NHS Trust, Bristol Heart Institute Coordinator of this site? Confirm its status | Bristol | United Kingdom | Unknown status |
| Golden Jubilee National Hospital Coordinator of this site? Confirm its status | Glasgow | United Kingdom | Unknown status |
| St. George's University Hospitals NHS Foundation Trust Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Manchester University NHS Foundation Trust, Wythenshawe Hospital Coordinator of this site? Confirm its status | Manchester | United Kingdom | Unknown status |
| Universitair Medische Centra Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Unknown status |
| Academic Medical Center Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Unknown status |
| Amphia Ziekenhuis Coordinator of this site? Confirm its status | Breda | Netherlands | Unknown status |
| Catharina Ziekenhuis Coordinator of this site? Confirm its status | Eindhoven | Netherlands | Unknown status |
| Medisch Centrum Leeuwarden Coordinator of this site? Confirm its status | Leeuwarden | Netherlands | Unknown status |
| Sint Antonius Ziekenhuis Coordinator of this site? Confirm its status | Nieuwegein | Netherlands | Unknown status |
| Radboud Universitair Medisch Centrum (Radboud UMC) Coordinator of this site? Confirm its status | Nijmegen | Netherlands | Unknown status |
| Universitair Medisch Centrum Coordinator of this site? Confirm its status | Utrecht | Netherlands | Unknown status |
| Narodowy Instytut Kardiologii Stefana Kardynała Wyszyńskiego Państwowy Instytut Badawczy Coordinator of this site? Confirm its status | Warsaw | Poland | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.