ULTRA LONG: BioFreedom Ultra

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective Multicenter Single Arm Trial to Assess the Safety and Effectiveness of Additional Sizes of the BioFreedom Ultra CoCr Biolimus A9 Coated Coronary Stent System

Conditions
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Coronary Artery Disease, High Bleeding Risk Patients

Intervention / Treatment
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* Device: BioFreedom Ultra


Participation Criteria
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Eligibility Criteria
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Clinical: 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. Patients must provide written informed consent Patient is at least 18 years old Patients with a life expectancy of > 1 year at time of consent 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: 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: Pregnant and breastfeeding women Patients lacking capacity (i.e. patients suffering from dementia and others) to provide informed consent Patients not expected to comply with 1 month of DAPT Staged procedures in the target vessel Active bleeding at the time of inclusion Cardiogenic shock Unlikely compliance with long-term single anti-platelet therapy 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 Currently participating in another trial before reaching primary endpoint Patients under judicial protection, tutorship or curatorship (France only)

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
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective, multi-center, open-label single-arm study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BioFreedom Ultra<br>All patients will receive the BioFreedom Ultra as per treatment. | Device: BioFreedom Ultra<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TLF | Incidence of Target Lesion Failure, clinically-driven target lesion revascularization (cd-TLR), Cardiovascular Death and TV-MI | at 9 months after index procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CD-TLR | Incidence of Clinically driven Target Lesion Revascularization | Clinical endpoints measured at 9 and 24 months | 
| Cardiovascular Death | Incidence | Clinical endpoints measured at 9 and 24 months | 
| TV-MI | Target-Vessel Myocardial Infarction | Clinical endpoints measured at 9 and 24 months | 
| TVR | Target Vessel Revascularization | Clinical endpoints measured at 9 and 24 months | 
| Stent thrombosis rate - definite/probable | Incidence | Clinical endpoints measured at 9 and 24 months | 
| All cause mortality | Incidence | Clinical endpoints measured at 9 and 24 months | 
| Bleeding rate (BARC 2-5) | Incidence of BARC 2-5 | Clinical endpoints measured at 9 and 24 months | 
| Peri-procedural endpoints | Incidence of Device success; Lesion success and Procedure success | Peri-procedural endpoints measured at 9 and 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BioFreedom Ultra