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

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).

Study Overview

• Status: Completed
• Conditions: Cardiac Disease; PCI; High Bleeding Risk
• Intervention / Treatment: Device: Supraflex Cruz 60 Micron; Device: Ultimaster Tansei 80 Micron

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.

• Study Type: Interventional
• Enrollment (Actual): 736
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • 's-Hertogenbosch, Netherlands
    • Jeroen Bosch Ziekenhuis
  • Amersfoort, Netherlands
    • Meander ziekenhuis
  • Arnhem, Netherlands
    • Rijnstate Ziekenhuis
  • Blaricum, Netherlands
    • Tergooi ziekenhuis Blaricum
  • Breda, Netherlands
    • Amphia Ziekenhuis
  • Dordrecht, Netherlands
    • Albert Schweitzer Ziekenhuis
  • Eindhoven, Netherlands
    • Catherina ziekenhuis
  • Leeuwarden, Netherlands
    • MCL Leeuwarden
  • Nieuwegein, Netherlands
    • St.Antonius ziekenhuis
  • Rotterdam, Netherlands
    • Maasstadziekenhuis
  • Terneuzen, Netherlands
    • Ziekenhuis Zorgsaam

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1 year
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	1 year
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	1 year
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	1 year
The composite of cardiovascular death, myocardial infarction and stroke	The composite endpoint of cardiovascular death, myocardial infarction and stroke	1 year
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	1 year
Stent thrombosis	Stent thrombosis according to the ARC definitions	1 year
Myocardial infarction	Myocardial infarction.	1 year
Urgent target vessel revascularization	Urgent target vessel revascularization.	1 year
Non-target vessel revascularization	Non-target vessel revascularization.	1 year
Clinically indicated target vessel revascularization	Clinically indicated target vessel revascularization.	1 year
Bleeding events	Bleeding events according to the BARC, TIMI and GUSTO classification	1 year
Transfusion rates	Transfusion rates both in patients with and/or without clinically detected over bleeding	1 year
Event rates according to the PRECISE-DAPT	Event rates according to the PRECISE-DAPT score	1 year
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)	At completion of the baseline PCI
Device success	Device success (applying a lesion-level analysis)	At discharge of baseline hospitalisation, on average 3 days

Collaborators and Investigators

• Sponsor: Pieter C.Smits
• Collaborators: Sahajanand Medical Technologies Limited
• Investigators: Principal Investigator: Pieter Smits, MD, PhD, Research Maatschap Cardiologen Rotterdam Zuid

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2020
• Primary Completion (Actual): September 1, 2023
• Study Completion (Actual): September 1, 2023

Study Registration Dates

• First Submitted: July 26, 2020
• First Submitted That Met QC Criteria: August 3, 2020
• First Posted (Actual): August 5, 2020

Study Record Updates

• Last Update Posted (Actual): September 15, 2023
• Last Update Submitted That Met QC Criteria: September 14, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Heart Diseases; Hemorrhage
• Other Study ID Numbers: NL73419.100.20

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No