eUltra 10k - Biofreedom Ultra

Biosensors Europe SA10,000 enrolled

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.

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

10,000

Conditions

Post Market Clinical Follow up (PMCF)

Interventions

Biofreedom UltraDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (10)

Krankenhaus Barmherzige Brüder

Eisenstadt, Austria

RECRUITING

Clinique Des Domes Psr

Clermont-Ferrand, France

RECRUITING

Klinikum Lippe

Detmold, Germany

Outcomes

Primary Outcomes

Target Lesion Failure (TLF)

Time frame: 12 months

Secondary Outcomes

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

Central Contacts

Calvin Bahr, MS

CONTACT

+41 21 804 80 24 c.bahr@biosensors.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.