eUltra 10k - Biofreedom Ultra

Biosensors International

Status: Enrolling

Conditions: Post Market Clinical Follow up (PMCF)

Treatments: Device: Biofreedom Ultra

Study type: Observational

Funder types: NETWORK; Industry

Identifiers

NCT05505929

22-EU-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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