Zilver PTX Post-Market Study in Japan

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02254837
Recruitment Status : Completed
First Posted : October 2, 2014
Last Update Posted : July 27, 2018
Information provided by (Responsible Party):
Cook Group Incorporated

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

Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease (PAD) Device: Zilver PTX Drug-Eluting Stent Not Applicable

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
Actual Primary Completion Date : June 30, 2018
Actual Study Completion Date : June 30, 2018

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

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

Information from the National Library of Medicine

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

Inclusion Criteria:

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

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 identifier (NCT number): NCT02254837

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Cook Group Incorporated Identifier: NCT02254837     History of Changes
Other Study ID Numbers: 12-005-PTX
First Posted: October 2, 2014    Key Record Dates
Last Update Posted: July 27, 2018
Last Verified: July 2018

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