eUltra 10k - Biofreedom Ultra

Recruiting

• Conditions: Post Market Clinical Follow up (PMCF)

• Registration Number: NCT05505929
• Lead Sponsor: Biosensors Europe SA

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.

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 Timeline

• Study First Submitted: 2022-08-16
• Study First Submitted QC: 2022-08-16
• Study First Posted: 2022-08-18
• Study Start: 2023-06-15
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-22
• Last Update Posted: 2023-08-23
• Primary Completion: 2028-12-31
• Study Completion: 2029-03-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Target Lesion Failure (TLF)	12 months

Secondary Outcome Measures

Name	Time	Method
Clinically driven Target Lesion Revascularization (TLR)	12 months
Cardiovascular death (CD)	12 months
Target Vessel Revascularization (TVR)	12 months
Stent thrombosis	12 months
Target Vessel MI	12 months

Trial Locations

Locations (1)

Royal Bournemouth hospital; 🇬🇧 Bournemouth, United Kingdom