eUltra 10k - Biofreedom Ultra

NCT05505929 · tracked via the Priya Life Science Germany tracker

Sponsor

Biosensors Europe SA

Phase

Observational

Started

2023-06-15

Last updated

2026-03-04

Condition(s) studied

Post Market Clinical Follow up (PMCF)

Investigational drug(s) / intervention(s)

Biofreedom Ultra

Biofreedom Ultra: The BioFreedomTM 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.

Study summary

This registry captures data on BioFreedomTM Ultra CoCr DCS in standard clinical practice (real world population) and serves as Post Market Clinical Follow up (PMCF) as part of the Post-Market Surveillance.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * According to the current version of Instructions of Use (IFU) * Patient is at least 18 years old * Patient provides a signed informed consent Exclusion Criteria: * According to current version of IFU * Patients will be excluded as per Medical Device Regulation (MDR) (Article 65: "Clinical investigations on minors" and article 66: "Clinical investigations on pregnant or breastfeeding women" * Patients will be excluded if they are under judicial protection, guardianship or curatorship or if they are deprived of their liberty by judicial or administrative decision

Primary outcome measure(s)

Target Lesion Failure (TLF) — 12 months

Trial sites (10)

Facility	City	Region	Status
Krankenhaus Barmherzige Brüder	Eisenstadt	Austria	Recruiting
Clinique Des Domes Psr	Clermont-Ferrand	France	Recruiting
Klinikum Lippe	Detmold	Germany	Recruiting
Hospital Marques Valdecilla	Santander	Spain	Recruiting
University and Hospital Fribourg	Fribourg	Switzerland	Recruiting
Universitäres Herzzentrum	Zurich	Switzerland	Recruiting
Military hospital	Tunis	Tunisia	Recruiting
Al Qassimi Hospital	Sharjah city	United Arab Emirates	Recruiting
Royal Bournemouth hospital	Bournemouth	United Kingdom	Recruiting
Golden Jubilee National Hospital	Glasgow	United Kingdom	Recruiting

More Biosensors Europe SA trials in Germany

ALPHA LONG Study- BioMatrix AlphaTM Stent Study in Patients With CAD Active, not recruiting

LEADERS FREE II: BioFreedom™ Pivotal Study Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05505929 on ClinicalTrials.gov ↗ ← All trials in Germany