NCT02254837CompletedNot Applicable
Zilver PTX Post-Market Surveillance Study of Paclitaxel-Eluting Stents for Treating Femoropopliteal Artery Disease in Japan
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Cook Group Incorporated
- Enrollment
- 909
- Primary Endpoint
- Rate of adverse events
Study Overview
Brief Summary
Japanese post market clinical study of the Zilver PTX device.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Symptomatic peripheral arterial disease (PAD) involving the above-the-knee femoropopliteal arteries
Exclusion Criteria
- Not provided
Arms & Interventions
Zilver PTX
Experimental
Intervention: Zilver PTX Drug-Eluting Stent (Device)
Outcomes
Primary Outcomes
Rate of adverse events
Time Frame: 5 years
Occurrence of stent fracture
Time Frame: 5 years
Secondary Outcomes
No secondary outcomes reported
Investigators
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