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ULTRA LONG: BioFreedom Ultra

NCT05643430 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2025-06-29

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Biosensors Europe SA

    lead INDUSTRY

Principal Investigators

  • Philippe Garot, Professor · Cardiovascular Institute Paris Sud (ICPS)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-27
Primary Completion
2026-03-08
Completion
2026-08-31

Countries

  • France
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05643430 on ClinicalTrials.gov