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Zilver Flex 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: NCT02254356
Recruitment Status : Completed
First Posted : October 1, 2014
Last Update Posted : March 30, 2018
Information provided by (Responsible Party):
Cook Group Incorporated

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

Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease (PAD) Device: Zilver Flex Bare Metal Stent Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 239 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Zilver PTX Post-Market Surveillance Study of Bare Metal Stents for Treating Femoropopliteal Artery Disease in Japan
Study Start Date : May 2012
Actual Primary Completion Date : December 26, 2017
Actual Study Completion Date : December 26, 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Zilver Device: Zilver Flex Bare Metal Stent

Primary Outcome Measures :
  1. Occurrence of stent fracture [ Time Frame: 3 years ]
  2. Rate of adverse events [ Time Frame: 3 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

Exclusion Criteria:


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): NCT02254356

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Fukuoka Sanno Hospital
Fukuoka, Japan, 814-0001
Sponsors and Collaborators
Cook Group Incorporated
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Principal Investigator: Michael D Dake, MD Department of Cardiothoracic Surgery, Stanford University Medical Center, Stanford, CA
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Responsible Party: Cook Group Incorporated Identifier: NCT02254356    
Other Study ID Numbers: 12-005-FLX
First Posted: October 1, 2014    Key Record Dates
Last Update Posted: March 30, 2018
Last Verified: March 2018
Keywords provided by Cook Group Incorporated:
drug-eluting stent, paclitaxel-eluting stent, peripheral artery disease, peripheral vascular disease, superficial femoral artery, popliteal artery
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Peripheral Vascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases