ClinicalTrials.gov Identifier: NCT04500912

Patients in the Study 731

Randomized Controlled Trial

 
in
High Bleeding Risk PCI Population

*Supraflex Cruz is registered trademark of Sahajanand Medical Technologies Ltd. or its addiliates.
**Ultimaster and Tansei are trademarks of Terumo Corporation.

Study Description

study design


An Investigator-initiated, multi-center, randomized controlled trial in HBR patients.

STUDY POPULATION

736 HBR patients (1:1 randomization) as per the ARC-HBR 2019 consensus definition.

STUDY ARMS


Treatment arm – Supraflex Cruz (60 µm) sirolimus-eluting stent Comparative arm – Ultimaster Tansei (80 µm) sirolimus-eluting stent.

PRIMARY ENDPOINT

Net Adverse Clinical Endpoints (NACE) defined as a composite of cardiovascular death, MI, TVR, stroke and major bleeding events defined as per BARC 3 or 5 at 12 months.

DAPT TREATMENT

According to the Guidelines of the European Society of Cardiology for Myocardial Revascularization 2019.

FOLLOW-UP


1 month, 6 months and 12 months post index PCI procedure.

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Study Team

Steering Committee

Dr. Jeroen Vos


Maasstad Ziekenhuis, Rotterdam,
The Netherlands

Dr. Jan-Peter van Kuijk

St. Antonius Ziekenhuis
Nieuwegein,
The Netherlands

Estimated Study Timeline

CRO

Site Management and Monitoring

Participating Sites

  • Rijnstate Ziekenhuis, Arnhem, The Netherlands
  • Amphia Ziekenhuis, Breda, The Netherlands
  • Albert Schweitzer Ziekenhuis, Dordrecht, The Netherlands
  • Catharina Ziekenhuis, Eindhoven, The Netherlands
  • Medical Center Leeuwarden, Leeuwarden, The Netherlands
  • St. Antonius Ziekenhuis, Nieuwegein, The Netherlands
  • Maasstad Ziekenhuis, Rotterdam, The Netherlands
  • Ziekenhuis Zorgsaam, Terneuzen, The Netherlands
  • Meander Medisch Centrum, Amersfoort, The Netherlands
  • Jeroen Bosch Ziekenhuis, s-Hertogenbosch, The Netherlands
  • Tergooi ziekenhuis, Blaricum, The Netherlands