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The EasyFlype/EasyHiFlype Post Market Clinical Follow-up Study.
Sponsor: CID S.p.A.
Summary
The Easy Flype Carbostent™ is a CE-marked nitinol self-expanding stent for superficial femoral artery (SFA) and Easy HiFlype Carbostent™is a CE-marked nitinol self-expanding stent for iliac vessels. The aim of this post-market retrospective study protocl P42201 is to collect clinical data of patients treated with Easy Flype or Easy Hi Flype for the stenosis or occlusion of the iliac artery, femoral artery and first third of the popliteal artery 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 these devices at least 12 months prior to the study start.
Official title: Self-expanding Stent for the Treatment of Peripheral Artery Disease: Evaluation of Safety and Performance in Everyday Clinical Practice. The EasyFlype/EasyHiFlype Post Market Clinical Follow-up Study.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
52
Start Date
2023-03-18
Completion Date
2024-05-28
Last Updated
2026-10-22
Healthy Volunteers
No
Interventions
Easy Flype/EasyHiFlype
Patients with stenosis or occlusion of the iliac artery, femoral artery and first third of the popliteal artery, implanted with at least one study device, the Easy Flype or the Easy Hi Flype.
Locations (2)
Ospedale S. Giovanni di Dio
Florence, Italy
Ospedale di Treviso
Treviso, Italy