eUltra 10k - Biofreedom Ultra
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Biofreedom Ultra.
- Who it may be relevant to
- Registry conditions: Post Market Clinical Follow up (PMCF). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Austria, France, Germany, Spain, Switzerland +3
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Post-Market Registry of the BioFreedom Ultra CoCr Biolimus A9 Coated Coronary Stent System
Overview
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.
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.
Interventions
- Device 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.
Primary outcome measures
- Target Lesion Failure (TLF) [Time frame: 12 months]
Secondary outcome measures (5)
- Clinically driven Target Lesion Revascularization (TLR) [Time frame: 12 months]
- Cardiovascular death (CD) [Time frame: 12 months]
- Target Vessel MI [Time frame: 12 months]
- Target Vessel Revascularization (TVR) [Time frame: 12 months]
- Stent thrombosis [Time frame: 12 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Switzerland · 2 centers
- University and Hospital Fribourg — Fribourg
- Universitäres Herzzentrum — Zurich
United Kingdom · 2 centers
- Royal Bournemouth hospital — Bournemouth
- Golden Jubilee National Hospital — Glasgow
Austria · 1 center
- Krankenhaus Barmherzige Brüder — Eisenstadt
France · 1 center
- Clinique Des Domes Psr — Clermont-Ferrand
Germany · 1 center
- Klinikum Lippe — Detmold
Spain · 1 center
- Hospital Marques Valdecilla — Santander
Tunisia · 1 center
- Military hospital — Tunis
United Arab Emirates · 1 center
- Al Qassimi Hospital — Sharjah city
Identifiers
NCT: NCT05505929 · 22-EU-01