NCT05643430

Brief 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.

Trial Health

78
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P25-P50 for not_applicable coronary-artery-disease

Timeline
4mo left

Started Feb 2024

Geographic Reach
2 countries

9 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress87%
Feb 2024Aug 2026

First Submitted

Initial submission to the registry

October 28, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 8, 2022

Completed
1.2 years until next milestone

Study Start

First participant enrolled

February 27, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 8, 2026

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2026

Expected
Last Updated

June 29, 2025

Status Verified

June 1, 2025

Enrollment Period

2 years

First QC Date

October 28, 2022

Last Update Submit

June 25, 2025

Conditions

Coronary Artery DiseaseHigh Bleeding Risk Patients

Keywords

BioFreedom Ultra

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • CD-TLR

    Clinical endpoints measured at 9 and 24 months

  • Cardiovascular Death

    Clinical endpoints measured at 9 and 24 months

  • TV-MI

    Clinical endpoints measured at 9 and 24 months

  • TVR

    Clinical endpoints measured at 9 and 24 months

  • Stent thrombosis rate - definite/probable

    Clinical endpoints measured at 9 and 24 months

  • +3 more secondary outcomes

Study Arms (1)

BioFreedom Ultra

EXPERIMENTAL

All patients will receive the BioFreedom Ultra as per treatment.

Device: BioFreedom Ultra

Interventions

BioFreedom UltraDEVICE

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.

BioFreedom Ultra

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Cardiovascular Institute Paris Sud (ICPS) L'Hôpital Privé Jacques Cartier

Massy, Massy, 91300, France

Location

Arnault Institute Tzanck

Saint-Laurent-du-Var, Saint-Laurent-du-Var, 06700, France

Location

Pôle Santé République

Clermont-Ferrand, 63050, France

Location

University Hospitals Birmingham (UHB)

Birmingham, B15 2TH, United Kingdom

Location

Royal Blackburn Hospital

Blackburn, BB2 3HH, United Kingdom

Location

Hull University Teaching Hospitals (HUTH)

Hull, HU3 2JZ, United Kingdom

Location

United Lincolnshire Hospitals (ULH)

Lincoln, United Kingdom

Location

The Grange University Hospital, Newport

Newport, NP44 8YN, United Kingdom

Location

Royal Albert Edward Infirmary

Wigan, WN1 2NN, United Kingdom

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Philippe Garot, Professor

    Cardiovascular Institute Paris Sud (ICPS)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Prospective, multi-center, open-label single-arm study
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2022

First Posted

December 8, 2022

Study Start

February 27, 2024

Primary Completion

March 8, 2026

Study Completion (Estimated)

August 31, 2026

Last Updated

June 29, 2025

Record last verified: 2025-06

Locations

FR(3)GB(6)