Assessing a new coronary stent for patients at high risk of bleeding

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

This study is testing new sizes of a special heart stent to see if they are safe and effective for patients who are at high risk of bleeding during heart procedures.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 86 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Biosensors Europe SA (Industry-sponsored)
• Drugs / interventions: chemotherapy
• Locations: 9 sites (Clermont-Ferrand and 8 other locations)
• Trial ID: NCT05643430 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and effectiveness of additional sizes of the BioFreedom Ultra CoCr Biolimus A9 coated coronary stent system in patients who are at high risk of bleeding. It is a prospective, multi-center, open-label single-arm study that aims to determine if these new stent sizes maintain the same clinical safety and efficacy as the already approved sizes. Participants will be monitored for their response to the stent and any associated complications. The study focuses on patients undergoing percutaneous coronary intervention (PCI) with specific eligibility criteria related to bleeding risk.

Who should consider this trial

Good fit: Ideal candidates include patients aged 18 and older who are at high bleeding risk and require PCI due to conditions like chronic coronary syndrome or unstable angina.

Not a fit: Patients who do not meet the high bleeding risk criteria or those with a life expectancy of less than one year may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a safer stenting option for patients at high risk of bleeding, improving their treatment outcomes.

How similar studies have performed: Other studies have shown success with similar stent technologies, indicating potential for positive outcomes in this approach.

Eligibility 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)

Where this trial is running

Clermont-Ferrand and 8 other locations

• Pôle Santé République — Clermont-Ferrand, France (Active_not_recruiting)
• Cardiovascular Institute Paris Sud (ICPS) L'Hôpital Privé Jacques Cartier — Massy, France (Active_not_recruiting)
• Arnault Institute Tzanck — Saint-Laurent-du-Var, France (Active_not_recruiting)
• University Hospitals Birmingham (UHB) — Birmingham, United Kingdom (Recruiting)
• Royal Blackburn Hospital — Blackburn, United Kingdom (Recruiting)
• Hull University Teaching Hospitals (HUTH) — Hull, United Kingdom (Recruiting)
• United Lincolnshire Hospitals (ULH) — Lincoln, United Kingdom (Recruiting)
• The Grange University Hospital, Newport — Newport, United Kingdom (Recruiting)
• Royal Albert Edward Infirmary — Wigan, United Kingdom (Recruiting)

Study contacts

• Principal investigator: Philippe Garot, Professor — Cardiovascular Institute Paris Sud (ICPS)
• Study coordinator: Diana Schuette

Conditions Coronary Artery Disease; High Bleeding Risk Patients; BioFreedom Ultra