Coronary Artery Disease, High Bleeding Risk Patients
Conditions
Keywords
BioFreedom Ultra
Brief summary
The goal of this Prospective, multi-center, open-label single-arm study is to Assess the Safety and Effectiveness of additional sizes of the BioFreedom Ultra CoCr Biolimus A9 coated coronary stent system in Patients at high risk of bleeding (HBR). The main question it aims to answer is to evaluate if the additional sizes of the BioFreedom Ultra have corresponding clinical safety and efficacy characteristics as the regulatory approved (=CE Marked) sizes.
Interventions
DEVICEBioFreedom Ultra
The BioFreedom Ultra CoCr DCS is a combination product consisting of two key components: the cobalt chromium stent platform coated abluminally with the active ingredient BA9TM (polymer and carrier free) and the delivery system.
Sponsors
Biosensors Europe SA
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective, multi-center, open-label single-arm study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Clinical: 1. Patients at high bleeding risk (HBR) with an indication for PCI. This includes subjects with chronic coronary syndrome, unstable angina, or non-ST elevation myocardial infarction. 2. Patients must provide written informed consent 3. Patient is at least 18 years old 4. Patients with a life expectancy of \> 1 year at time of consent 5. HBR patients defined according to the ARC-HBR criteria and suitable to receive dual anti platelet therapy (DAPT) for one month. To be qualified HBR, patients have to have at least 1 major and/or 2 minor criteria defined as follow: Major Minor Age ≥75 years old Anticipated use of long-term oral anticoagulation\* Severe or end-stage CKD (eGFR \<30 mL/min) Moderate CKD (eGFR 30-59 mL/min) Hemoglobin \<11 g/dL Hemoglobin 11-12.9 g/dL for men and 11-11.9 g/dL for women Spontaneous bleeding requiring hospitalization or transfusion in the past 6 months or at any time, if recurrent Spontaneous bleeding requiring hospitalization or transfusion within the past 12 months not meeting the major criterion Moderate or severe baseline thrombocytopenia† (platelet count \<100×109/L) Chronic bleeding diathesis Liver cirrhosis with portal hypertension Long-term use of oral NSAIDs or steroids Active malignancy‡ (excluding non-melanoma skin cancer) within the past 12 months Previous spontaneous ICH (at any time) Previous traumatic ICH within the past 12 months Presence of a bAVM Moderate or severe ischemic stroke§ within the past 6 months Any ischemic stroke at any time not meeting the major criterion Nondeferrable major surgery on DAPT Recent major surgery or major trauma within 30 days before PCI bAVM indicates brain arteriovenous malformation; CKD, chronic kidney disease; DAPT, dual antiplatelet therapy; eGFR, estimated glomerular filtration rate; HBR, high bleeding risk; ICH, intracranial hemorrhage; NSAID, nonsteroidal anti-inflammatory drug; and PCI, percutaneous coronary intervention. \*This excludes vascular protection doses. †Baseline thrombocytopenia is defined as thrombocytopenia before PCI. ‡Active malignancy is defined as diagnosis within 12 months and/or ongoing requirement for treatment (including surgery, chemotherapy, or radiotherapy). §National Institutes of Health Stroke Scale score ≥5. Angiographic: 6. Patients scheduled to undergo PCI of a de novo lesion (no in-stent restenosis) with reference vessel diameter and lesion length suitable for treatment with at least one study device
Exclusion criteria
1. Pregnant and breastfeeding women 2. Patients lacking capacity (i.e. patients suffering from dementia and others) to provide informed consent 3. Patients not expected to comply with 1 month of DAPT 4. Staged procedures in the target vessel 5. Active bleeding at the time of inclusion 6. Cardiogenic shock 7. Unlikely compliance with long-term single anti-platelet therapy 8. Known hypersensitivity or contraindication to aspirin, clopidogrel (or to any other P2Y12 inhibitor if applicable), cobalt chromium, zinc, Biolimus A9 or a sensitivity to contrast media, which cannot be adequately pre-medicated 9. Currently participating in another trial before reaching primary endpoint 10. Patients under judicial protection, tutorship or curatorship (France only)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| TLF | at 9 months after index procedure | Incidence of Target Lesion Failure, clinically-driven target lesion revascularization (cd-TLR), Cardiovascular Death and TV-MI |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cardiovascular Death | Clinical endpoints measured at 9 and 24 months | Incidence |
| TV-MI | Clinical endpoints measured at 9 and 24 months | Target-Vessel Myocardial Infarction |
| TVR | Clinical endpoints measured at 9 and 24 months | Target Vessel Revascularization |
| CD-TLR | Clinical endpoints measured at 9 and 24 months | Incidence of Clinically driven Target Lesion Revascularization |
| All cause mortality | Clinical endpoints measured at 9 and 24 months | Incidence |
| Bleeding rate (BARC 2-5) | Clinical endpoints measured at 9 and 24 months | Incidence of BARC 2-5 |
| Peri-procedural endpoints | Peri-procedural endpoints measured at 9 and 24 months | Incidence of Device success; Lesion success and Procedure success |
| Stent thrombosis rate - definite/probable | Clinical endpoints measured at 9 and 24 months | Incidence |
Countries
France, United Kingdom
Outcome results
None listed