This trial is active, not recruiting.

Condition peripheral arterial disease (pad)
Treatment zilver ptx drug-eluting stent
Sponsor Cook
Start date May 2012
End date February 2018
Trial size 909 participants
Trial identifier NCT02254837, 12-005-PTX


Japanese post market clinical study of the Zilver PTX 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 ptx drug-eluting stent

Primary Outcomes

Occurrence of stent fracture
time frame: 5 years
Rate of adverse events
time frame: 5 years

Eligibility Criteria

Male or female participants of any age.

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

Additional Information

Official title Zilver PTX Post-Market Surveillance Study of Paclitaxel-Eluting 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 October 2016.
Information provided to ClinicalTrials.gov by Cook.