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Not Yet Recruiting NCT05616169

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

Conditions: Peripheral Artery Disease, Peripheral Arterial Occlusive Disease

Sex: All
Ages: 18 Years – N/A
Enrollment: 80
Sponsor: CID S.p.A.

Location: Italy

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.

Eligibility Criteria

Inclusion Criteria:Patient has been implanted with at least one study stent according to the indications described in the IFUStudy device implantation date is at least one year (12 months) prior to the starting date of the retrospective anonymous data collectionExclusion Criteria:Patients treated less than 12 months prior to study start

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05616169). StuddyBuddy aggregates publicly available trial information.