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Zilver PTX Post-Market Study in Japan

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ClinicalTrials.gov Identifier: NCT02254837
Recruitment Status : Active, not recruiting
First Posted : October 2, 2014
Last Update Posted : November 13, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Japanese post market clinical study of the Zilver PTX device.

Condition or disease Intervention/treatment
Peripheral Arterial Disease (PAD) Device: Zilver PTX Drug-Eluting Stent

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 909 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Zilver PTX Post-Market Surveillance Study of Paclitaxel-Eluting Stents for Treating Femoropopliteal Artery Disease in Japan
Study Start Date : May 2012
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2018
Arms and Interventions

Arm Intervention/treatment
Experimental: Zilver PTX Device: Zilver PTX Drug-Eluting Stent


Outcome Measures

Primary Outcome Measures :
  1. Occurrence of stent fracture [ Time Frame: 5 years ]
  2. Rate of adverse events [ Time Frame: 5 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Symptomatic peripheral arterial disease (PAD) involving the above-the-knee femoropopliteal arteries
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02254837


Sponsors and Collaborators
Cook Group Incorporated
Investigators
Principal Investigator: Michael D Dake, MD Department of Cardiothoracic Surgery, Stanford University Medical Center, Stanford, CA
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Cook Group Incorporated
ClinicalTrials.gov Identifier: NCT02254837     History of Changes
Other Study ID Numbers: 12-005-PTX
First Posted: October 2, 2014    Key Record Dates
Last Update Posted: November 13, 2017
Last Verified: November 2017

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases