NCT05643430Active, not recruiting
ULTRA LONG: BioFreedom Ultra
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
Source: ClinicalTrials.gov · Last updated 29 Jun 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 86 (estimated)
- First submitted
- 28 Oct 2022
- Start date
- 27 Feb 2024
- Primary completion date
- 8 Mar 2026
- Lead sponsor
- Biosensors Europe SA
- Diseases
- Coronary artery disease
- NCT number
- NCT05643430
What you commit to
- Study type: Interventional
- Planned participants: 86
- From 27 Feb 2024 to the primary completion date, 8 Mar 2026
- 9 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patients lacking capacity (i.e. patients suffering from dementia and others) to provide informed consent
- Active bleeding at the time of inclusion
- 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
Lab values
- Unlikely compliance with long-term single anti-platelet therapy
Other
- Pregnant and breastfeeding women
- Patients not expected to comply with 1 month of DAPT
- Staged procedures in the target vessel
- Cardiogenic shock
- Currently participating in another trial before reaching primary endpoint
- Patients under judicial protection, tutorship or curatorship (France only)
Criteria the registry did not label
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (9)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Pôle Santé République Coordinator of this site? Confirm its status | Clermont-Ferrand | France | Unknown status |
| Cardiovascular Institute Paris Sud (ICPS) L'Hôpital Privé Jacques Cartier Coordinator of this site? Confirm its status | Massy | France | Unknown status |
| Arnault Institute Tzanck Coordinator of this site? Confirm its status | Saint-Laurent-du-Var | France | Unknown status |
| University Hospitals Birmingham (UHB) Coordinator of this site? Confirm its status | Birmingham | United Kingdom | Unknown status |
| Royal Blackburn Hospital Coordinator of this site? Confirm its status | Blackburn | United Kingdom | Unknown status |
| Hull University Teaching Hospitals (HUTH) Coordinator of this site? Confirm its status | Hull | United Kingdom | Unknown status |
| United Lincolnshire Hospitals (ULH) Coordinator of this site? Confirm its status | Lincoln | United Kingdom | Unknown status |
| The Grange University Hospital, Newport Coordinator of this site? Confirm its status | Newport | United Kingdom | Unknown status |
| Royal Albert Edward Infirmary Coordinator of this site? Confirm its status | Wigan | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.