← Back to all trials
Completed
NCT05616156
The Cre8™ BTK Post Market Clinical Follow-up Study
Conditions: Peripheral Arterial Disease
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 30
Sponsor: CID S.p.A.
Location: Pliclinico Abano terme Abano Terme Padova
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.
