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NCT Number: NCT05505929

eUltra 10k - Biofreedom Ultra

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Krankenhaus Barmherzige Brüder, Eisenstadt, Austria

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BioFreedom Ultra

Device

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.

Primary outcomes

  1. Target Lesion Failure (TLF)

    Time frame: 12 months

Secondary outcomes

  1. Clinically driven Target Lesion Revascularization (TLR)

    Time frame: 12 months

  2. Cardiovascular death (CD)

    Time frame: 12 months

  3. Target Vessel MI

    Time frame: 12 months

  4. Target Vessel Revascularization (TVR)

    Time frame: 12 months

  5. Stent thrombosis

    Time frame: 12 months

Study contacts

Contact information is provided by the study sponsor or research team.

Calvin Bahr, MS

CONTACT

[email protected]

+41 21 804 80 24

Sponsors and collaborators

Lead sponsor

Biosensors Europe SA

Industry

Collaborators

  • European Cardiovascular Research Center

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2028
Study completion
2029
First posted
Aug 18, 2022
Registry last updated
Mar 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.