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Cardiac DiseaseNCT04500912

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

A study testing Supraflex Cruz 60 Micron and Ultimaster Tansei 80 Micron in people with Cardiac Disease and PCI, run by Pieter C.Smits at 11 sites in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cardiac Disease, PCI, High Bleeding Risk
What is being tested?
Supraflex Cruz 60 Micron and Ultimaster Tansei 80 Micron
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
736 participants
Where
11 sitesNetherlands
Study dates
14 Sep 2020to 1 Sep 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

Netherlands11 sites

  • Jeroen Bosch ziekenhuis

    's-Hertogenbosch

  • Meander ziekenhuis

    Amersfoort

  • Rijnstate ziekenhuis

    Arnhem

  • Tergooi ziekenhuis Blaricum

    Blaricum

  • Amphia Ziekenhuis

    Breda

  • Albert Schweitzer ziekenhuis

    Dordrecht

  • Catherina ziekenhuis

    Eindhoven

  • MCL Leeuwarden

    Leeuwarden

  • St.Antonius ziekenhuis

    Nieuwegein

  • Maasstadziekenhuis

    Rotterdam

  • Ziekenhuis Zorgsaam

    Terneuzen

Other trials in Netherlands

About this study

Official title: Comparison of the Supraflex Cruz 60 Micron Stent Strut Versus the Ultimaster Tansei 80 Micron Stent Strut in High Bleeding Risk PCI Population

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).

Read the 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, who undergo a PCI and are at high risk for bleeding (HBR).

Intervention: Patients are treated according to the randomized regimen at index PCI and at planned staged procedures. Either with the ultrathin stent strut Supraflex Cruz stent to the thin stent strut Ultimaster Tansei stent

DAPT treatment (combination and duration) is according to the Guidelines of the European Society of Cardiology for Myocardial Revascularization.

Follow-up is scheduled at 1 month, 6 months and 12 months post index PCI procedure.

Primary study parameters/outcome of the study:

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.

Being tested
Supraflex Cruz 60 Micron, Ultimaster Tansei 80 Micron
Medical subject headings
Heart Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Supraflex Cruz 60 MicronDevice

    percutaneous coronary intervention

  • Ultimaster Tansei 80 MicronDevice

    percutaneous coronary intervention

Study groups in NCT04500912
Study groupRoleWhat they receive
Supraflex Cruz stentActive comparatorRandomization to Supraflex Cruz stent
Receives: Device: Supraflex Cruz 60 Micron
Ultimaster Tansei stentActive comparatorRandomization to Ultimaster Tansei stent
Receives: Device: Ultimaster Tansei 80 Micron

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 1 year

Secondary outcomes (16)

  1. Major adverse cardiac and cerebral events (MACCE)

    Major adverse cardiac and cerebral events (MACCE) defined as a composite of cardiac death, myocardial infarction, target vessel revascularization and stroke

    Measured: 1 year

  2. Major or clinically relevant non-major bleeding (MCB)

    Major or clinically relevant non-major bleeding (MCB) defined as a composite of type 2, 3 and 5 BARC bleeding events

    Measured: 1 year

  3. Target Lesion Failure (TLF)

    Target Lesion Failure (TLF) is defined as cardiac death, myocardial infarction attributed to the target vessel and clinically indicated target lesion revascularization

    Measured: 1 year

  4. Target vessel failure (TVF)

    Target Vessel Failure (TVF) is defined as cardiac death, myocardial infarction attributed to the target vessel and clinically indicated target vessel revascularization

    Measured: 1 year

  5. The composite of cardiovascular death, myocardial infarction and stroke

    The composite endpoint of cardiovascular death, myocardial infarction and stroke

    Measured: 1 year

  6. The composite of cardiovascular death, myocardial infarction, stroke and major bleed BARC 3 and 5

    The composite of cardiovascular death, myocardial infarction, stroke and major bleed according to BARC 3 and 5

    Measured: 1 year

  7. Stent thrombosis

    Stent thrombosis according to the ARC definitions

    Measured: 1 year

  8. Myocardial infarction

    Myocardial infarction.

    Measured: 1 year

  9. Urgent target vessel revascularization

    Urgent target vessel revascularization.

    Measured: 1 year

  10. Non-target vessel revascularization

    Non-target vessel revascularization.

    Measured: 1 year

  11. Clinically indicated target vessel revascularization

    Clinically indicated target vessel revascularization.

    Measured: 1 year

  12. Bleeding events

    Bleeding events according to the BARC, TIMI and GUSTO classification

    Measured: 1 year

  13. Transfusion rates

    Transfusion rates both in patients with and/or without clinically detected over bleeding

    Measured: 1 year

  14. Event rates according to the PRECISE-DAPT

    Event rates according to the PRECISE-DAPT score

    Measured: 1 year

  15. Procedural success

    Procedural success is defined as angiographic success with no in-hospital MACE, defined as death, MI with new Q-waves on electrocardiogram (ECG) or urgent target vessel revascularization (TVR) (including both repeat PCI and coronary artery bypass graft surgery (CABG)

    Measured: At completion of the baseline PCI

  16. Device success

    Device success (applying a lesion-level analysis)

    Measured: At discharge of baseline hospitalisation, on average 3 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Aug 2020
  2. Study start14 Sep 2020
  3. Primary completion1 Sep 2023
  4. Study completion1 Sep 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
736 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04500912
Sponsor's protocol ID
NL73419.100.20
Status last verified
Sep 2023
First submitted
26 Jul 2020
Last updated
15 Sep 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 39351676

  • 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.

    PubMed 34503738

Questions about this trial

What is this clinical trial studying?

A study testing Supraflex Cruz 60 Micron and Ultimaster Tansei 80 Micron in people with Cardiac Disease and PCI, run by Pieter C.Smits at 11 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 27 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Net Adverse Clinical Endpoints (NACE) (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04500912, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2023.

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