NCT04500912

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
736

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2020

Typical duration for not_applicable

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 26, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 5, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

September 14, 2020

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

September 15, 2023

Status Verified

September 1, 2023

Enrollment Period

3 years

First QC Date

July 26, 2020

Last Update Submit

September 14, 2023

Conditions

Cardiac DiseasePCIHigh Bleeding Risk

Outcome Measures

Primary Outcomes (1)

  • Net Adverse Clinical Endpoints (NACE)

    The primary endpoint Net Adverse Clinical Endpoints (NACE) defined as a composite of cardiovascular death, myocardial infarction, target vessel revascularization, stroke and bleeding events defined as BARC 3 or 5 at 12 months follow-up after the index PCI.

    1 year

Secondary Outcomes (16)

  • Major adverse cardiac and cerebral events (MACCE)

    1 year

  • Major or clinically relevant non-major bleeding (MCB)

    1 year

  • Target Lesion Failure (TLF)

    1 year

  • Target vessel failure (TVF)

    1 year

  • The composite of cardiovascular death, myocardial infarction and stroke

    1 year

  • +11 more secondary outcomes

Study Arms (2)

Supraflex Cruz stent

ACTIVE COMPARATOR

Randomization to Supraflex Cruz stent

Device: Supraflex Cruz 60 Micron

Ultimaster Tansei stent

ACTIVE COMPARATOR

Randomization to Ultimaster Tansei stent

Device: Ultimaster Tansei 80 Micron

Interventions

Supraflex Cruz 60 MicronDEVICE

percutaneous coronary intervention

Supraflex Cruz stent
Ultimaster Tansei 80 MicronDEVICE

percutaneous coronary intervention

Ultimaster Tansei stent

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +11 more criteria

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Jeroen Bosch ziekenhuis

's-Hertogenbosch, Netherlands

Location

Meander ziekenhuis

Amersfoort, Netherlands

Location

Rijnstate ziekenhuis

Arnhem, Netherlands

Location

Tergooi ziekenhuis Blaricum

Blaricum, Netherlands

Location

Amphia Ziekenhuis

Breda, Netherlands

Location

Albert Schweitzer ziekenhuis

Dordrecht, Netherlands

Location

Catherina ziekenhuis

Eindhoven, Netherlands

Location

MCL Leeuwarden

Leeuwarden, Netherlands

Location

St.Antonius ziekenhuis

Nieuwegein, Netherlands

Location

Maasstadziekenhuis

Rotterdam, Netherlands

Location

Ziekenhuis Zorgsaam

Terneuzen, Netherlands

Location

Related Publications (2)

  • Smits PC, Tonino PAL, Hofma SH, van Kuijk JP, Spano F, Al Mafragi A, Pisters R, Polad J, Bogaerts K, Oemrawsingh RM, Paradies V. Comparison of Ultrathin- Versus Thin-Strut Stents in Patients With High Bleeding Risk PCI: Results From the COMPARE 60/80 HBR Trial: An Open-Label, Randomized, Controlled Trial. Circ Cardiovasc Interv. 2024 Oct;17(10):e014042. doi: 10.1161/CIRCINTERVENTIONS.123.014042. Epub 2024 Oct 1.

    PMID: 39351676DERIVED

  • Capodanno D. Another Coronary Stent for Patients at High Bleeding Risk. JACC Cardiovasc Interv. 2021 Sep 13;14(17):1884-1887. doi: 10.1016/j.jcin.2021.07.028. No abstract available.

    PMID: 34503738DERIVED

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

  • Pieter Smits, MD, PhD

    Research Maatschap Cardiologen Rotterdam Zuid

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Patient will be blinded for the stent that is used
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

July 26, 2020

First Posted

August 5, 2020

Study Start

September 14, 2020

Primary Completion

September 1, 2023

Study Completion

September 1, 2023

Last Updated

September 15, 2023

Record last verified: 2023-09

Locations

NL(11)