ULTRA LONG: BioFreedom Ultra

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05643430
• Other study ID #: 22-EU-02
• Status: Recruiting
• Phase: N/A
• Start date: February 27, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: June 2024
• Source: Biosensors Europe SA
• Contact: Diana Schuette
• Phone: +41(0)218048000
• Email: d.schuette[@]biosensors.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 86
• Est. completion date: December 31, 2025
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Coronary Artery Disease
• High Bleeding Risk Patients

Intervention

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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Biosensors Europe SA

Countries where clinical trial is conducted

France,  United Kingdom, 

Outcome

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