Cardiac Disease Clinical Trial
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
Verified date | September 2023 |
Source | Research Maatschap Cardiologen Rotterdam Zuid |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 736 |
Est. completion date | September 1, 2023 |
Est. primary completion date | September 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
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 |
Lead Sponsor | Collaborator |
---|---|
Pieter C.Smits | Sahajanand Medical Technologies Limited |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | The composite of cardiovascular death, myocardial infarction and stroke | The composite endpoint of cardiovascular death, myocardial infarction and stroke | 1 year | |
Secondary | 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 | |
Secondary | Stent thrombosis | Stent thrombosis according to the ARC definitions | 1 year | |
Secondary | Myocardial infarction | Myocardial infarction. | 1 year | |
Secondary | Urgent target vessel revascularization | Urgent target vessel revascularization. | 1 year | |
Secondary | Non-target vessel revascularization | Non-target vessel revascularization. | 1 year | |
Secondary | Clinically indicated target vessel revascularization | Clinically indicated target vessel revascularization. | 1 year | |
Secondary | Bleeding events | Bleeding events according to the BARC, TIMI and GUSTO classification | 1 year | |
Secondary | Transfusion rates | Transfusion rates both in patients with and/or without clinically detected over bleeding | 1 year | |
Secondary | Event rates according to the PRECISE-DAPT | Event rates according to the PRECISE-DAPT score | 1 year | |
Secondary | 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 | |
Secondary | Device success | Device success (applying a lesion-level analysis) | At discharge of baseline hospitalisation, on average 3 days |
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