NCT05505929

eUltra 10k - Biofreedom Ultra

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 10,000 (estimated)
• Sponsor: Biosensors Europe SA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Post Market Clinical Follow up (PMCF)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-06-15
• Primary completion: 2028-12-31
• Completion: 2029-03-30
• First posted: 2022-08-18
• Last updated: 2026-03-04

Locations

10 sites across 8 countries: Austria, France, Germany, Spain, Switzerland, Tunisia, United Arab Emirates, United Kingdom