eUltra 10k - Biofreedom Ultra

Sponsor

Biosensors Europe SA (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05505929

Collaborator

European Cardiovascular Research Center (Other)

10,000

Enrollment

77.5

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Post Market Clinical Follow up (PMCF)	Device: Biofreedom Ultra

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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

10000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Oct 15, 2022

Anticipated Primary Completion Date :

Dec 31, 2028

Anticipated Study Completion Date :

Mar 30, 2029

Outcome Measures

Primary Outcome Measures

Target Lesion Failure (TLF) [12 months]

Secondary Outcome Measures

Clinically driven Target Lesion Revascularization (TLR) [12 months]
Cardiovascular death (CD) [12 months]
Target Vessel MI [12 months]
Target Vessel Revascularization (TVR) [12 months]
Stent thrombosis [12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Biosensors Europe SA
European Cardiovascular Research Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Biosensors Europe SA

ClinicalTrials.gov Identifier:

NCT05505929

Other Study ID Numbers:

22-EU-01

First Posted:

Aug 18, 2022

Last Update Posted:

Aug 18, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Biosensors Europe SA

Study Results

No Results Posted as of Aug 18, 2022