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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cardiac Disease, PCI, High Bleeding Risk

Intervention / Treatment
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* Device: Supraflex Cruz 60 Micron
* Device: Ultimaster Tansei 80 Micron


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Supraflex Cruz stent<br>Randomization to Supraflex Cruz stent | Device: Supraflex Cruz 60 Micron<br>* percutaneous coronary intervention<br>|
| Active Comparator: Ultimaster Tansei stent<br>Randomization to Ultimaster Tansei stent | Device: Ultimaster Tansei 80 Micron<br>* percutaneous coronary intervention<br>|

What is the study measuring?
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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 |