eUltra 10k - Biofreedom Ultra

March 2, 2026 updated by: Biosensors Europe SA

A Post-Market Registry of the BioFreedom Ultra CoCr Biolimus A9 Coated Coronary Stent System

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Prospective, observational multi-center registry to be conducted at up to 150 interventional cardiology centers in up to 15 countries. Patients will be followed by telephone for 1 year after PCI for data collection. This registry captures data on BioFreedomTM Ultra CoCr DCS in standard clinical practice (real world population) and serves as Post-Market Surveillance.

This registry will enroll up to 10000 patients in up to 150 investigative centers in Europe, South America, Middle East, Asia over a period of 5 years. Each patient be followed with phone (or clinic) visit at 12 months.

Study Type

Observational

Enrollment (Estimated)

10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Austria
      • Eisenstadt, Austria
        • Recruiting
        • Krankenhaus Barmherzige Brüder
        • Contact:
          • Rudolf Berger, Prof.
  • France
      • Clermont-Ferrand, France
        • Recruiting
        • Clinique Des Domes Psr
        • Contact:
          • Janusz Lipiecki, MD
  • Germany
      • Detmold, Germany
        • Recruiting
        • Klinikum Lippe
        • Contact:
          • Stephan Gielen, Prof
  • Spain
      • Santander, Spain
        • Recruiting
        • Hospital Marques Valdecilla
        • Contact:
          • José Maria de La Torre Hernández, MD
  • Switzerland
      • Fribourg, Switzerland
        • Recruiting
        • University and Hospital Fribourg
        • Contact:
          • Stéphane Cook, Prof
      • Zurich, Switzerland
        • Recruiting
        • Universitäres Herzzentrum
        • Contact:
          • Barbara Stähli, Prof
  • Tunisia
      • Tunis, Tunisia
        • Recruiting
        • Military Hospital
        • Contact:
          • Nahdem Hajlaoui, Prof
  • United Arab Emirates
      • Sharjah city, United Arab Emirates
        • Recruiting
        • Al Qassimi Hospital
        • Contact:
          • Arif Al Nooryani, MD
  • United Kingdom
      • Bournemouth, United Kingdom
        • Recruiting
        • Royal Bournemouth Hospital
        • Contact:
          • Peter O'Kane, MD
      • Glasgow, United Kingdom
        • Recruiting
        • Golden Jubilee National Hospital
        • Contact:
          • Stuart Watkins, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This observational registry is open to all patients with coronary artery disease treated by percutaneous coronary intervention (PCI) with one or more BioFreedom™ Ultra CoCr DCS within the products indications of the Instructions for Use (IFU).

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Target Lesion Failure (TLF)
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Stent thrombosis
Time Frame: 12 months
12 months
Clinically driven Target Lesion Revascularization (TLR)
Time Frame: 12 months
12 months
Cardiovascular death (CD)
Time Frame: 12 months
12 months
Target Vessel MI
Time Frame: 12 months
12 months
Target Vessel Revascularization (TVR)
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biosensors Europe SA

Collaborators

European Cardiovascular Research Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2023

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

March 30, 2029

Study Registration Dates

First Submitted

August 16, 2022

First Submitted That Met QC Criteria

August 16, 2022

First Posted (Actual)

August 18, 2022

Study Record Updates

Last Update Posted (Actual)

March 4, 2026

Last Update Submitted That Met QC Criteria

March 2, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 22-EU-01

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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