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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Coronary Artery Disease; High Bleeding Risk Patients
• Intervention / Treatment: Device: BioFreedom Ultra

• Study Type: Interventional
• Enrollment (Estimated): 86
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France, 63050
    • Pôle Santé République
  • Massy, France, 91300
    • Cardiovascular Institute Paris Sud (ICPS) L'Hôpital Privé Jacques Cartier
  • Saint-Laurent-du-Var, France, 06700
    • Arnault Institute Tzanck
• United Kingdom
  • Birmingham, United Kingdom, B15 2TH
    • University Hospitals Birmingham (UHB)
  • Blackburn, United Kingdom, BB2 3HH
    • Royal Blackburn Hospital
  • Hull, United Kingdom, HU3 2JZ
    • Hull University Teaching Hospitals (HUTH)
  • Lincoln, United Kingdom
    • United Lincolnshire Hospitals (ULH)
  • Newport, United Kingdom, NP44 8YN
    • The Grange University Hospital, Newport
  • Wigan, United Kingdom, WN1 2NN
    • Royal Albert Edward Infirmary

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BioFreedom Ultra; All patients will receive the BioFreedom Ultra as per treatment.	Device: BioFreedom 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Biosensors Europe SA
• Investigators: Principal Investigator: Philippe Garot, Professor, Cardiovascular Institute Paris Sud (ICPS)

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2024
• Primary Completion (Estimated): March 8, 2026
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: October 28, 2022
• First Submitted That Met QC Criteria: December 7, 2022
• First Posted (Actual): December 8, 2022

Study Record Updates

• Last Update Posted (Actual): June 29, 2025
• Last Update Submitted That Met QC Criteria: June 25, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: BioFreedom Ultra
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Coronary Artery Disease
• Other Study ID Numbers: 22-EU-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No