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

NCT05616169 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2022-11-15

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

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.

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

More Related Trials

Entities

Diseases

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 NCT05616169 on ClinicalTrials.gov