This trial is active, not recruiting.

Condition peripheral arterial disease (pad)
Treatment zilver flex bare metal stent
Sponsor Cook
Start date May 2012
End date January 2018
Trial size 239 participants
Trial identifier NCT02254356, 12-005-FLX


Japanese post market clinical study of the Zilver Flex device.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
zilver flex bare metal stent

Primary Outcomes

Occurrence of stent fracture
time frame: 3 years
Rate of adverse events
time frame: 3 years

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: - Symptomatic peripheral arterial disease (PAD) involving the above-the-knee femoropopliteal arteries Exclusion Criteria:

Additional Information

Official title Zilver PTX Post-Market Surveillance Study of Bare Metal Stents for Treating Femoropopliteal Artery Disease in Japan
Principal investigator Michael D Dake, MD
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Cook.