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.
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 Type
OBSERVATIONAL
Enrollment
10,000
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.
Krankenhaus Barmherzige Brüder
Eisenstadt, Austria
RECRUITINGClinique Des Domes Psr
Clermont-Ferrand, France
RECRUITINGKlinikum Lippe
Detmold, Germany
Target Lesion Failure (TLF)
Time frame: 12 months
Clinically driven Target Lesion Revascularization (TLR)
Time frame: 12 months
Cardiovascular death (CD)
Time frame: 12 months
Target Vessel MI
Time frame: 12 months
Target Vessel Revascularization (TVR)
Time frame: 12 months
Stent thrombosis
Time frame: 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Hospital Marques Valdecilla
Santander, Spain
RECRUITINGUniversity and Hospital Fribourg
Fribourg, Switzerland
RECRUITINGUniversitäres Herzzentrum
Zurich, Switzerland
RECRUITINGMilitary hospital
Tunis, Tunisia
RECRUITINGAl Qassimi Hospital
Sharjah city, United Arab Emirates
RECRUITINGRoyal Bournemouth hospital
Bournemouth, United Kingdom
RECRUITINGGolden Jubilee National Hospital
Glasgow, United Kingdom
RECRUITING