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NCT02254837 Clinical Trial

Zilver PTX Post-Market Study in Japan

Peripheral Arterial Disease (PAD) Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02254837
Other study ID # 12-005-PTX
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 2012
Est. completion date June 30, 2018

Study information
Verified date July 2019
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 PTX device.

Recruitment information / eligibility
Status Completed
Enrollment 909
Est. completion date June 30, 2018
Est. primary completion date June 30, 2018
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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Zilver PTX Drug-Eluting Stent

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Cook Group Incorporated

Outcome
Type Measure Description Time frame Safety issue
Primary Occurrence of stent fracture 5 years
Primary Rate of adverse events 5 years
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