Zilver Flex Post-Market Study in Japan

Not Applicable

Completed

• Conditions: Peripheral Arterial Disease (PAD)
• Interventions: Device: Zilver Flex Bare Metal Stent

• Registration Number: NCT02254356
• Lead Sponsor: Cook Group Incorporated

Brief Summary

Japanese post market clinical study of the Zilver Flex device.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2014-09-29
• Study First Submitted QC: 2014-09-29
• Study First Posted: 2014-10-01
• Primary Completion: 2017-12-26
• Study Completion: 2017-12-26
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-29
• Last Update Posted: 2018-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 239

Inclusion Criteria

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

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Zilver	Zilver Flex Bare Metal Stent	-

Primary Outcome Measures

Name	Time	Method
Occurrence of stent fracture	3 years
Rate of adverse events	3 years

Trial Locations

Locations (1)

Fukuoka Sanno Hospital; 🇯🇵 Fukuoka, Japan