The Cre8™ BTK Post Market Clinical Follow-up Study
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.
1 other identifier
observational
50
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Feb 2023
Shorter than P25 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 8, 2022
CompletedFirst Posted
Study publicly available on registry
November 15, 2022
CompletedStudy Start
First participant enrolled
February 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2023
CompletedNovember 15, 2022
November 1, 2022
4 months
November 8, 2022
November 8, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Rate of Major Adverse Events (MAE)
Composite endpoint of all causes of death, unplanned target limb major amputation and/or clinically indicated target lesion revascularization (TLR)
12 months
Secondary Outcomes (9)
Primary patency
6 months and 12 months
Limb-salvage rate (LSR)
6 months and 12 months
Secondary patency
6 months and 12 months or latest patency data available
Death
30 days
Clinically driven Target Lesion Revascularization
6 months and 12 months
- +4 more secondary outcomes
Interventions
Implant of Cre8™ BTK stent the treatment of infrapopliteal peripheral artery disease
Eligibility Criteria
Patients with infrapopliteal ischemic obstruction, implanted with at least one Cre8™ BTK drug eluting stent at least 12 months prior to the start date of the retrospective data collection.
You may qualify if:
- 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.
You may not qualify if:
- Patients treated less than 12 months prior to study start
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CID S.p.A.lead
- Meditrial Europe Ltd.collaborator
Study Sites (2)
Pliclinico Abano terme
Abano Terme, Padova, Italy
Grande Ospedale Metropolitano Bianchi Melacrino Morelli
Reggio Calabria, Italy
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 8, 2022
First Posted
November 15, 2022
Study Start
February 1, 2023
Primary Completion
June 1, 2023
Study Completion
July 1, 2023
Last Updated
November 15, 2022
Record last verified: 2022-11
Data Sharing
- IPD Sharing
- Will not share