• Patients in the Study 007


ClinicalTrials.gov Identifier: NCT04500912

Patients in the Study 007

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.

Twitter Timeline

Study Team

DR. PIETER C. SMITS
Study Chairman and Principal Investigator MD, PhD Maasstad Hospital
Rotterdam,
The Netherlands

Steering Committee

Dr. Pieter C. Smits

Maasstad Ziekenhuis, Rotterdam,
The Netherlands

Dr. Pim Tonino

Catharina Ziekenhuis
Eindhoven,
The Netherlands

Dr. Sjoerd Hofma

MCL
Leeuwarden,
The Netherlands

Dr. Jeroen Vos


Maasstad Ziekenhuis, Rotterdam,
The Netherlands

Dr. Jan-Peter van Kuijk

St. Antonius Ziekenhuis
Nieuwegein,
The Netherlands

Estimated Study Timeline

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Sponsor

Research Maatschap Cardiologen Rotterdam Zuid,
Maasstad Ziekenhuis, Rotterdam

Collaborator

Sahajanand Medical Techologies Ltd.



CRO

Site Management and Monitoring
Image Description
Monitoring of Maasstad Ziekenhuis and
CRF Development
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Data Management, Central Data Review and
Statistical Analysis
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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