← Back to all trials
Not Yet Recruiting
NCT05616156
The Cre8™ BTK Post Market Clinical Follow-up Study
Conditions: Peripheral Arterial Disease
Sex: All
Ages: 18 Years – N/A
Enrollment: 50
Sponsor: CID S.p.A.
Location: Italy
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.
Eligibility Criteria
Inclusion Criteria:Patient has been implanted with at least one Cre8™ BTK device according to the indications described in the Instructions for Use (IFU),Study device implantation date is at least one year (12 months) prior to the starting date of the retrospective anonymous data collection.Exclusion Criteria:Patients treated less than 12 months prior to study start
Source: ClinicalTrials.gov (NCT05616156). StuddyBuddy aggregates publicly available trial information.