NCT03805048View on ClinicalTrials.gov

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

NAActive, not recruitingINTERVENTIONAL
Enrollment

221

Participants

Timeline

Start Date

January 22, 2019

Primary Completion Date

January 31, 2028

Study Completion Date

June 30, 2028

Conditions
Coronary Artery Disease
Interventions
PROCEDURE

Percutaneous coronary intervention

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.

Trial Locations (21)

1105

Academic Medical Center, Amsterdam

2020

Ziekenhuis Netwerk Antwerpen (ZNA) Middelheim, Antwerp

3000

UZ Leuven, Leuven

3435

Sint Antonius Ziekenhuis, Nieuwegein

8934

Medisch Centrum Leeuwarden, Leeuwarden

79189

Universitäts Herzzentrum, Bad Krozingen

B 2650

University Hospital, Antwerp

B-3600

Ziekenhuis Oost-Limburg, Genk

1081 HV

Universitair Medische Centra, Amsterdam

4818 CK

Amphia Ziekenhuis, Breda

Unknown

Catharina Ziekenhuis, Eindhoven

Radboud Universitair Medisch Centrum (Radboud UMC), Nijmegen

3584 CX

Universitair Medisch Centrum, Utrecht

04-628

Narodowy Instytut Kardiologii Stefana Kardynała Wyszyńskiego Państwowy Instytut Badawczy, Warsaw

SS16 5NL

Basildon & Thurrock University Hospitals (Essex CTC), Basildon

BT8 8BH

Health and Social Care Trust, Belfast

BH7 7DW

The Royal Bournemouth & Christchurch Hospitals NHS Foundation Trust, Bournemouth

BS1 3NU

UH Bristol NHS Trust, Bristol Heart Institute, Bristol

G81 4HX

Golden Jubilee National Hospital, Glasgow

SW17 0QT

St George's University Hospitals NHS Foundation Trust, London

M23 9LT

Manchester University NHS Foundation Trust, Wythenshawe Hospital, Manchester

All Listed Sponsors
lead

Amsterdam UMC, location VUmc

OTHER

NCT03805048 - PeRcutaneous cOronary Intervention of Native Coronary arTery Versus Venous Bypass Graft in Patients With Prior CABG | Biotech Hunter | Biotech Hunter