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NCT02254356 Clinical Trial

Zilver Flex Post-Market Study in Japan

Peripheral Arterial Disease (PAD) Clinical Trial

Official title:
Zilver PTX Post-Market Surveillance Study of Bare Metal Stents for Treating Femoropopliteal Artery Disease in Japan

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02254356
Other study ID # 12-005-FLX
Secondary ID
Status Completed
Phase N/A
First received September 29, 2014
Last updated March 29, 2018
Start date May 2012
Est. completion date December 26, 2017

Study information
Verified date March 2018
Source Cook Group Incorporated
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Japanese post market clinical study of the Zilver Flex device.

Recruitment information / eligibility
Status Completed
Enrollment 239
Est. completion date December 26, 2017
Est. primary completion date December 26, 2017
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Zilver Flex Bare Metal Stent

Locations
Country Name City State
Japan Fukuoka Sanno Hospital Fukuoka

Sponsors (1)
Lead Sponsor Collaborator
Cook Group Incorporated

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Occurrence of stent fracture 3 years
Primary Rate of adverse events 3 years
See also
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Not yet recruiting NCT06457685 - Amplitude Vascular Systems (AVS) Lithotripsy POWER PAD 2 Trial N/A
Recruiting NCT05246410 - A Clinical Trial to Evaluate the Efficacy and Safety of a Spot Stent System Used in Femoropopliteal Arteries. N/A
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