Zilver Flex Post-Market Study in Japan

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02254356

Enrollment

239

Registered

2014-10-01

Start date

2012-05-31

Completion date

2017-12-26

Last updated

2018-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral Arterial Disease (PAD)

Keywords

drug-eluting stent, paclitaxel-eluting stent, peripheral artery disease, peripheral vascular disease, superficial femoral artery, popliteal artery

Brief summary

Japanese post market clinical study of the Zilver Flex device.

Interventions

DEVICEZilver Flex Bare Metal Stent

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

Design outcomes

Primary

Measure	Time frame
Occurrence of stent fracture	3 years
Rate of adverse events	3 years

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026