The EasyFlype/EasyHiFlype Post Market Clinical Follow-up Study.

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial Description

The objective of this post-market study is to systematically collect retrospective clinical data on the implantable medical devices EasyFlype/EasyHiFlype in the daily clinical practice in an unselected population treated within the intended use. Data will be collected via medical chart review in anonymous form to assess the safety and efficacy of EasyFlype/EasyHiFlype. 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05616169
Study type	Observational
Source	CID S.p.A.
Contact	Franco Vallana, MD
Phone	+39 0161 18261
Email	franco.vallana@alvimedica.com
Status	Not yet recruiting
Phase
Start date	February 2023
Completion date	July 2023

View Details

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