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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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