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Zilver Flex Post-Market Study in Japan

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ClinicalTrials.gov Identifier: NCT02254356
Recruitment Status : Completed
First Posted : October 1, 2014
Last Update Posted : March 30, 2018
Sponsor:
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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 239 participants
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 ]


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

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 ClinicalTrials.gov identifier (NCT number): NCT02254356


Locations
Japan
Fukuoka Sanno Hospital
Fukuoka, Japan, 814-0001
Sponsors and Collaborators
Cook Group Incorporated
Investigators
Principal Investigator: Michael D Dake, MD Department of Cardiothoracic Surgery, Stanford University Medical Center, Stanford, CA

Responsible Party: Cook Group Incorporated
ClinicalTrials.gov Identifier: NCT02254356     History of Changes
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:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases