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The Cre8™ BTK Post Market Clinical Follow-up Study

NCT05616156 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2022-11-15

No results posted yet for this study

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.

Conditions

  • Peripheral Arterial Disease

Interventions

DEVICE

Cre8™ BTK

Implant of Cre8™ BTK stent the treatment of infrapopliteal peripheral artery disease

Sponsors & Collaborators

  • Meditrial Europe Ltd.

    collaborator INDUSTRY

  • CID S.p.A.

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-28
Primary Completion
2023-06-30
Completion
2023-07-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05616156 on ClinicalTrials.gov