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

NCT03805048 | Active Not Recruiting DMC

• 1 other identifier: Amsterdam UMC
• Study Type: interventional
• Target: 221
• Locations: 5 countries
• Sites: 21

Brief 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.

Conditions

Coronary Artery Disease

Keywords

Percutaneous Coronary Intervention; Dysfunctional venous bypass graft; Second generation DES; CABG

Outcome Measures

Primary Outcomes (1)

• Amount and type of Major Adverse Cardiac Events

  The total number and specification of major adverse cardiac events (all-cause mortality, non-fatal myocardial infarction, or clinically driven target lesion revascularization).

  3 year follow up

Secondary Outcomes (13)

• Amount and type of Major Adverse Cardiac Events

  1 and 5 year follow-up

• Amount of patients that have passed away

  1, 3 and 5 year follow-up

• Number of non-fatal myocardial infarctions

  1, 3 and 5 year follow-up

• Number of clinically driven target lesion revascularizations

  1, 3 and 5 year follow-up

• Number of target vessel revascularizations

  1, 3 and 5 year follow-up

Study Arms (2)

Native Vessel PCI

OTHER

All patients with a significant stenosis (\>50% on coronary angiography) in a venous bypass graft discussed in the local heart team for revascularization will be screened for potential inclusion in the study. Percutaneous coronary intervention of the native vessel will be performed according to current standard. 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 four complementary techniques to cross a CTO: antegrade wire escalation, antegrade dissection reentry, retrograde wire escalation and retrograde dissection reentry.

Procedure: Percutaneous coronary intervention

Graft PCI

OTHER

All patients with a significant stenosis (\>50% on coronary angiography) in a venous bypass graft discussed in the local heart team for revascularization will be screened for potential inclusion in the study. Percutaneous coronary intervention of the bypass graft will be performed following current standards and at the discretion of the operating interventional cardiologist. Only commercially available second generation DES will be used in the treatment of bypass grafts. The second generation DES used in this study will be the XIENCE Sierra stent. The use of a filter-wire during the procedure will be left at the discretion of the operator.

Procedure: Percutaneous coronary intervention

Interventions

Percutaneous coronary intervention PROCEDURE

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.

Graft PCI; Native Vessel PCI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \< 18 years of age
• 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
• Severe kidney disease defined as an eGFR \< 30 ml/min.
• Pregnancy
• Estimated life expectancy \< 3 year
• Contraindications to PCI

Sponsors & Collaborators

• Amsterdam UMC, location VUmc: lead

Study Sites (21)

University Hospital

Antwerp, Edegem, B 2650, Belgium

Location

Ziekenhuis Netwerk Antwerpen (ZNA) Middelheim

Antwerp, 2020, Belgium

Location

Ziekenhuis Oost-Limburg

Genk, B-3600, Belgium

Location

UZ Leuven

Leuven, 3000, Belgium

Location

Universitäts Herzzentrum

Bad Krozingen, 79189, Germany

Location

Universitair Medische Centra

Amsterdam, 1081 HV, Netherlands

Location

Academic Medical Center

Amsterdam, 1105, Netherlands

Location

Amphia Ziekenhuis

Breda, 4818 CK, Netherlands

Location

Catharina Ziekenhuis

Eindhoven, Netherlands

Location

Medisch Centrum Leeuwarden

Leeuwarden, 8934, Netherlands

Location

Sint Antonius Ziekenhuis

Nieuwegein, 3435, Netherlands

Location

Radboud Universitair Medisch Centrum (Radboud UMC)

Nijmegen, Netherlands

Location

Universitair Medisch Centrum

Utrecht, 3584 CX, Netherlands

Location

Narodowy Instytut Kardiologii Stefana Kardynała Wyszyńskiego Państwowy Instytut Badawczy

Warsaw, 04-628, Poland

Location

Basildon & Thurrock University Hospitals (Essex CTC)

Basildon, SS16 5NL, United Kingdom

Location

Health and Social Care Trust

Belfast, BT8 8BH, United Kingdom

Location

The Royal Bournemouth & Christchurch Hospitals NHS Foundation Trust

Bournemouth, BH7 7DW, United Kingdom

Location

UH Bristol NHS Trust, Bristol Heart Institute

Bristol, BS1 3NU, United Kingdom

Location

Golden Jubilee National Hospital

Glasgow, G81 4HX, United Kingdom

Location

St George's University Hospitals NHS Foundation Trust

London, SW17 0QT, United Kingdom

Location

Manchester University NHS Foundation Trust, Wythenshawe Hospital

Manchester, M23 9LT, United Kingdom

Location

Related Publications (1)

• de Winter RW, Hoek R, Walsh SJ, Hanratty CG, Sprengers RW, Twisk JWR, Vegting I, Schumacher SP, Bom MJ, Verouden NJ, Henriques JP, Wilgenhof A, Viscusi MM, Teeuwen K, Opolski MP, Wolny R, Agostoni P, van Kuijk JP, Scholzel BE, Kraaijeveld AO, van Geuns RM, Dirksen MT, Heestermans AACM, Dens J, Bennett J, Haine SEF, Delewi R, Nap A, Spratt JC, Knaapen P; PROCTOR Trial Investigators. PCI of Native Coronary Artery vs Saphenous Vein Graft After Prior Bypass Surgery: A Multicenter, Randomized Trial. J Am Coll Cardiol. 2026 Jan 27;87(3):269-282. doi: 10.1016/j.jacc.2025.09.1577. Epub 2025 Oct 28.

  PMID: 41159978 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Paul Knaapen

  Amsterdam UMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicipal Investigator

Model Details: Patients will be randomized to either native vessel PCI or PCI of the venous bypass graft in a 1:1 fashion. Randomization will be performed using an interactive Web-based randomization system, Open Clinica

Study Record Dates

• First Submitted: January 7, 2019
• First Posted: January 15, 2019
• Study Start: January 22, 2019
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: February 13, 2025

Record last verified: 2025-02

Locations

DE (1); NL (8); BE (4); PL (1); GB (7)