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

CID S.p.A.

Status: Not yet enrolling

Conditions: Peripheral Arterial Occlusive Disease; Peripheral Artery Disease

Treatments: Device: Easy Flype/EasyHiFlype

Study type: Observational

Funder types: Industry

Identifiers

NCT05616169

P42201

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient has been implanted with at least one study stent according to the indications described in the IFU
• Study device implantation date is at least one year (12 months) prior to the starting date of the retrospective anonymous data collection

Exclusion criteria

• Patients treated less than 12 months prior to study start