Zilver Flex Post-Market Study in Japan

Cook Group

Status: Completed

Conditions: Peripheral Arterial Disease (PAD)

Treatments: Device: Zilver Flex Bare Metal Stent

Study type: Interventional

Funder types: Industry

Identifiers

NCT02254356

12-005-FLX

Details and patient eligibility

About

Japanese post market clinical study of the Zilver Flex device.

Enrollment: 239 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Symptomatic peripheral arterial disease (PAD) involving the above-the-knee femoropopliteal arteries

Exclusion criteria

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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239 participants in 1 patient group

Zilver

Experimental group

Treatment:

Device: Zilver Flex Bare Metal Stent