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The Cre8™ BTK Post Market Clinical Follow-up Study
Sponsor: CID S.p.A.
Summary
Cre8™ BTK is a CE marked drug eluting stent, integrally coated with i-Carbofilm, loaded with formulated Sirolimus for the treatment of infrapopliteal peripheral artery disease. The aim of this post-market retrospective study protocol P32102 is to collect clinical data of patient treated with Cre8™ BTK stent in routine clinical practice. In order to obtain long-term follow-up data, the data collection will be limited to patients that have been treated with the Cre8™ BTK stent at least 12 months prior to the study start.
Official title: Sirolimus Drug-eluting Stent for the Treatment of Infrapopliteal Peripheral Artery Disease: Evaluation of Safety and Performance in Everyday Clinical Practice. The Cre8™ BTK Post Market Clinical Follow-up Study.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
30
Start Date
2023-04-12
Completion Date
2024-01-31
Last Updated
2026-10-22
Healthy Volunteers
No
Conditions
Interventions
Cre8™ BTK
Implant of Cre8™ BTK stent the treatment of infrapopliteal peripheral artery disease
Locations (2)
Pliclinico Abano terme
Abano Terme, Padova, Italy
Grande Ospedale Metropolitano Bianchi Melacrino Morelli
Reggio Calabria, Italy