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Clinical Trial 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.


Clinical Trial 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


NCT number NCT05505929
Study type Observational [Patient Registry]
Source Biosensors Europe SA
Contact Calvin Bahr, MS
Phone +41 21 804 80 24
Email c.bahr@biosensors.com
Status Recruiting
Phase
Start date June 15, 2023
Completion date March 30, 2029