Post Market Clinical Follow up (PMCF)
Conditions
Keywords
PMCF, Registry, Biofreedom Ultra, eUltra
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.
Interventions
DEVICEBiofreedom 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.
Sponsors
Biosensors Europe SA
European Cardiovascular Research Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Target Lesion Failure (TLF) | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Austria, France, Germany, Spain, Switzerland, Tunisia, United Arab Emirates, United Kingdom
Contacts
CONTACTCalvin Bahr, MS
Outcome results
None listed