NCT05616169

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

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.

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 80 (estimated)
• Sponsor: CID S.p.A. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Peripheral Artery Disease
• Peripheral Arterial Occlusive Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-02-01
• Primary completion: 2023-06-01
• Completion: 2023-07-01
• First posted: 2022-11-15
• Last updated: 2022-11-15

Locations

2 sites across 1 country: Italy