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Status:

COMPLETED

Comparison of the Supraflex Cruz 60 Micron Versus the Ultimaster Tansei 80 Micron in HBR PCI Population

Lead Sponsor:

Pieter C.Smits

Collaborating Sponsors:

Sahajanand Medical Technologies Limited

Conditions:

Cardiac Disease

PCI

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

The study compares the outcome of the ultrathin stent strut Supraflex Cruz stent to the thin stent strut Ultimaster Tansei stent in a PCI population at high risk for bleeding (HBR).

Detailed Description

Study design: An Investigator-initiated, multi-center, randomized clinical trial in HBR patients receiving PCI with Supraflex Cruz or Ultimaster Tansei stents Study population: 2 x 368 (736) patients...

Eligibility Criteria

Inclusion

  • Inclusion criteria:
  • Patients are eligible for inclusion into the study if the following criteria are met.
  • Patients of 18 years and above
  • Written or witnessed oral consent to participate in the study
  • Native coronary artery lesions eligible for PCI with stents with no restrictions in number of lesions and stents, vessel size or lesion complexity, apart from stent thrombosis.
  • Patients at high risk for bleeding according to the HBR ARC criteria: Patients meet the HBR ARC criteria if ≥1 major or ≥2 minor criteria are met.
  • Major HBR criteria are the following:
  • Clinical indication for treatment with oral anticoagulants (OAC/NOAC) for at least 12 months
  • Severe or end-stage chronic kidney failure (GFR ≤ 30 ml/min)
  • Hemoglobin (Hb) level at screening \< 11g/dl or \< 6.8 mmol/l
  • Spontaneous bleeding requiring hospitalization or transfusion in the past 6 months or at any time, if recurrent
  • Moderate or severe baseline true thrombocytopenia (platelet count \<100 \*10\^9/L)
  • History of chronic bleeding diathesis, like: leukemia, haemophilia, vitamin K deficiency, Factor V or VII deficiency etc.
  • Liver cirrhosis with portal hypertension
  • Active malignancy (other than skin) within the past 12 months
  • Spontaneous intracranial haemorrhage ICH (at any time)
  • Traumatic intracranial haemorrhage ICH within 12 months
  • Presence of a brain arterio-venous malformation (AVM)
  • Moderate or severe ischemic stroke within the past 6 months
  • Nondeferrable major surgery on DAPT after PCI
  • Recent major surgery or major trauma within 30 d before PCI
  • Minor HBR criteria are the following:
  • Age ≥ 75 years
  • Moderate chronic kidney disease (GFR \>30 and \<60 ml/min)
  • Hemoglobin (Hb) 11-12.9 g/dL / 6.8-8.0 mmol/l for men and 11-11.9 g/dL / 6.8-7.4 mmol/l for women
  • Any ischemic stroke at any time not meeting the major criterion
  • Spontaneous bleeding requiring hospitalization or transfusion within the past 12 months
  • Need for chronic treatment with steroids or non-steroidal anti-inflammatory drugs
  • Exclusion criteria:
  • Patients are not eligible if any of the following applies:
  • Treated with stents other than Supraflex Cruz or Ultimaster within 6 months prior to index procedure
  • Treatment of lesions with stent thrombosis
  • Treatment of venous or arterial coronary grafts
  • Treated for stent thrombosis in 12 months prior to index PCI procedure
  • Treated with a bioresorbable scaffold 3 years before index PCI procedure
  • Cardiogenic shock at index procedure
  • Active SARS-CoV-2 infection or suspicion of SARS-CoV-2 infection
  • Cannot provide written informed consent
  • Under judicial protection, tutorship or curatorship
  • Unable to understand and follow study-related instructions or unable to comply with study protocol
  • Active bleeding requiring medical attention (BARC≥2) at index PCI
  • Life expectancy less than one year
  • Known hypersensitivity or allergy for aspirin, clopidogrel, ticagrelor, prasugrel, cobalt chromium or sirolimus
  • Any anticipated PCI after index PCI, unless planned and scheduled at index PCI
  • Participation in another stent or drug trial

Exclusion

    Key Trial Info

    Start Date :

    September 14 2020

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    September 1 2023

    Estimated Enrollment :

    736 Patients enrolled

    Trial Details

    Trial ID

    NCT04500912

    Start Date

    September 14 2020

    End Date

    September 1 2023

    Last Update

    September 15 2023

    Active Locations (11)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 3 (11 locations)

    1

    Jeroen Bosch ziekenhuis

    's-Hertogenbosch, Netherlands

    2

    Meander ziekenhuis

    Amersfoort, Netherlands

    3

    Rijnstate ziekenhuis

    Arnhem, Netherlands

    4

    Tergooi ziekenhuis Blaricum

    Blaricum, Netherlands