Comparison of the Supraflex Cruz 60 micron stent strut versus the Ultimaster Tansei 80 micron stent strut in High Bleeding Risk PCI populatio

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 736

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 days 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 of 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 & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures