We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04500912
Recruitment Status : Active, not recruiting
First Posted : August 5, 2020
Last Update Posted : September 19, 2022
Sponsor:
Collaborator:
Sahajanand Medical Technologies Pvt. Ltd.
Information provided by (Responsible Party):
Pieter C.Smits, Research Maatschap Cardiologen Rotterdam Zuid

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).

Condition or disease Intervention/treatment Phase
Cardiac Disease PCI High Bleeding Risk Device: Supraflex Cruz 60 Micron Device: Ultimaster Tansei 80 Micron Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 736 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description: Patient will be blinded for the stent that is used
Primary Purpose: Treatment
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
Actual Study Start Date : September 14, 2020
Estimated Primary Completion Date : September 1, 2023
Estimated Study Completion Date : September 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
Active Comparator: Supraflex Cruz stent
Randomization to Supraflex Cruz stent
Device: Supraflex Cruz 60 Micron
percutaneous coronary intervention

Active Comparator: Ultimaster Tansei stent
Randomization to Ultimaster Tansei stent
Device: Ultimaster Tansei 80 Micron
percutaneous coronary intervention




Primary Outcome Measures :
  1. Net Adverse Clinical Endpoints (NACE) [ Time Frame: 1 year ]
    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.


Secondary Outcome Measures :
  1. Major adverse cardiac and cerebral events (MACCE) [ Time Frame: 1 year ]
    Major adverse cardiac and cerebral events (MACCE) defined as a composite of cardiac death, myocardial infarction, target vessel revascularization and stroke

  2. Major or clinically relevant non-major bleeding (MCB) [ Time Frame: 1 year ]
    Major or clinically relevant non-major bleeding (MCB) defined as a composite of type 2, 3 and 5 BARC bleeding events

  3. Target Lesion Failure (TLF) [ Time Frame: 1 year ]
    Target Lesion Failure (TLF) is defined as cardiac death, myocardial infarction attributed to the target vessel and clinically indicated target lesion revascularization

  4. Target vessel failure (TVF) [ Time Frame: 1 year ]
    Target Vessel Failure (TVF) is defined as cardiac death, myocardial infarction attributed to the target vessel and clinically indicated target vessel revascularization

  5. The composite of cardiovascular death, myocardial infarction and stroke [ Time Frame: 1 year ]
    The composite endpoint of cardiovascular death, myocardial infarction and stroke

  6. The composite of cardiovascular death, myocardial infarction, stroke and major bleed BARC 3 and 5 [ Time Frame: 1 year ]
    The composite of cardiovascular death, myocardial infarction, stroke and major bleed according to BARC 3 and 5

  7. Stent thrombosis [ Time Frame: 1 year ]
    Stent thrombosis according to the ARC definitions

  8. Myocardial infarction [ Time Frame: 1 year ]
    Myocardial infarction.

  9. Urgent target vessel revascularization [ Time Frame: 1 year ]
    Urgent target vessel revascularization.

  10. Non-target vessel revascularization [ Time Frame: 1 year ]
    Non-target vessel revascularization.

  11. Clinically indicated target vessel revascularization [ Time Frame: 1 year ]
    Clinically indicated target vessel revascularization.

  12. Bleeding events [ Time Frame: 1 year ]
    Bleeding events according to the BARC, TIMI and GUSTO classification

  13. Transfusion rates [ Time Frame: 1 year ]
    Transfusion rates both in patients with and/or without clinically detected over bleeding

  14. Event rates according to the PRECISE-DAPT [ Time Frame: 1 year ]
    Event rates according to the PRECISE-DAPT score

  15. Procedural success [ Time Frame: At completion of the baseline PCI ]
    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)

  16. Device success [ Time Frame: At discharge of baseline hospitalisation, on average 3 days ]
    Device success (applying a lesion-level analysis)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04500912


Locations
Layout table for location information
Netherlands
Jeroen Bosch ziekenhuis
's-Hertogenbosch, Netherlands
Meander ziekenhuis
Amersfoort, Netherlands
Rijnstate ziekenhuis
Arnhem, Netherlands
Tergooi ziekenhuis Blaricum
Blaricum, Netherlands
Amphia Ziekenhuis
Breda, Netherlands
Albert Schweitzer ziekenhuis
Dordrecht, Netherlands
Catherina ziekenhuis
Eindhoven, Netherlands
MCL Leeuwarden
Leeuwarden, Netherlands
St.Antonius ziekenhuis
Nieuwegein, Netherlands
Maasstadziekenhuis
Rotterdam, Netherlands
Ziekenhuis Zorgsaam
Terneuzen, Netherlands
Sponsors and Collaborators
Pieter C.Smits
Sahajanand Medical Technologies Pvt. Ltd.
Investigators
Layout table for investigator information
Principal Investigator: Pieter Smits, MD, PhD Research Maatschap Cardiologen Rotterdam Zuid
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Pieter C.Smits, MD, PhD, Research Maatschap Cardiologen Rotterdam Zuid
ClinicalTrials.gov Identifier: NCT04500912    
Other Study ID Numbers: NL73419.100.20
First Posted: August 5, 2020    Key Record Dates
Last Update Posted: September 19, 2022
Last Verified: September 2022

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Diseases
Hemorrhage
Pathologic Processes
Cardiovascular Diseases