Health TrialsbyHealthPanel

eUltra 10k - Biofreedom Ultra

ConditionPost Market Clinical Follow up (PMCF)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBiosensors Europe SA

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

According to the current version of Instructions of Use (IFU)

Patient is at least 18 years old

Patient provides a signed informed consent

Disqualifiers

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

Trial 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).

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

No treatment groups listed

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Biosensors Europe SA

Lead sponsor

European Cardiovascular Research Center

Collaborator

Source ClinicalTrials.gov
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