Zilver Flex Post-Market Study in Japan

NCT02254356 — Not applicable, Completed, 239 participants, Cook Group Incorporated
ClinicalTrials Daily  ·  Areas  ·  Conditions  ·  Drugs  ·  Sponsors  ·  

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

RegistryNCT02254356
StatusCompleted
PhaseNot applicable
Study typeInterventional; na, single group, masking: none, treatment
Enrollment239 (Actual)
SponsorCook Group Incorporated (Industry)
ConditionsPeripheral Arterial Disease (PAD)
InterventionsZilver Flex Bare Metal Stent (Device)
Datesstart 2012-05-01, primary completion 2017-12-26, completion 2017-12-26, first posted 2014-10-01, last updated 2018-03-30
Locations1 site in Japan

Related Papers Related Patents Related Grants Related Experts
All trials for Peripheral Arterial Disease (PAD) All trials of Zilver Flex Bare Metal Stent

-Summary

Japanese post market clinical study of the Zilver Flex device.

Expand all sections  ·  Collapse all

+Arms and interventions

ArmTypeInterventionsDescription
ZilverExperimentalDevice: Zilver Flex Bare Metal Stent
  • Zilver Flex Bare Metal Stent (Device)

+Outcome measures

Primary outcomes

  • Occurrence of stent fracture [3 years]
  • Rate of adverse events [3 years]

+Eligibility

Sex: All

Inclusion Criteria:

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

Exclusion Criteria:

\-

+Locations (1)

FacilityCityCountryStatus
Fukuoka Sanno HospitalFukuokaJapan

+Investigators

  • Michael D Dake, MD, Principal investigator, Department of Cardiothoracic Surgery, Stanford University Medical Center, Stanford, CA