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Zilver PTX Post-Market Study in Japan

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02254837
First Posted: October 2, 2014
Last Update Posted: November 10, 2017
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.
Information provided by (Responsible Party):
Cook Group Incorporated
  Purpose
Japanese post market clinical study of the Zilver PTX device.

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

Study Type: Interventional
Study Design: 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

Further study details as provided by Cook Group Incorporated:

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

Enrollment: 909
Study Start Date: May 2012
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Zilver PTX Device: Zilver PTX Drug-Eluting Stent

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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 Submitted: September 24, 2014
First Posted: October 2, 2014
Last Update Posted: November 10, 2017
Last Verified: November 2017

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