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Zilver® PTX® V Clinical Study

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Cook Group

Status

Completed

Conditions

Peripheral Arterial Disease

Treatments

Device: Zilver® PTX® Drug-Eluting Peripheral Stent

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

The Zilver® PTX® V Clinical Study is a post-market clinical trial required by the US FDA to provide continued evaluation of the safety and effectiveness of the Zilver PTX Drug-Eluting Peripheral Stent in treatment of narrowing of the femoropopliteal arteries.

Enrollment

200 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patient has signed and dated the informed consent.
  • Patient has symptomatic vascular disease of the native above-the-knee femoropopliteal arteries.
  • Patient agrees to return for the required follow-up assessments.

Exclusion criteria

  • Patient is < 18 years of age.
  • Patient has significant stenosis of inflow tract not successfully treated before this procedure.
  • Patient lacks at least one patent vessel of runoff with < 50% stenosis throughout its course.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

200 participants in 1 patient group

Drug-Eluting Stent
Experimental group
Treatment:
Device: Zilver® PTX® Drug-Eluting Peripheral Stent

Trial contacts and locations

17

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Data sourced from clinicaltrials.gov

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