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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.
 
ClinicalTrials.gov Identifier: NCT02254837
Recruitment Status : Completed
First Posted : October 2, 2014
Last Update Posted : July 12, 2019
Sponsor:
Information provided by (Responsible Party):
Cook Group Incorporated

Tracking Information
First Submitted Date  ICMJE September 24, 2014
First Posted Date  ICMJE October 2, 2014
Last Update Posted Date July 12, 2019
Study Start Date  ICMJE May 2012
Actual Primary Completion Date June 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 29, 2014)
  • Occurrence of stent fracture [ Time Frame: 5 years ]
  • Rate of adverse events [ Time Frame: 5 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Zilver PTX Post-Market Study in Japan
Official Title  ICMJE Zilver PTX Post-Market Surveillance Study of Paclitaxel-Eluting Stents for Treating Femoropopliteal Artery Disease in Japan
Brief Summary Japanese post market clinical study of the Zilver PTX device.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Peripheral Arterial Disease (PAD)
Intervention  ICMJE Device: Zilver PTX Drug-Eluting Stent
Study Arms  ICMJE Experimental: Zilver PTX
Intervention: Device: Zilver PTX Drug-Eluting Stent
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 29, 2014)
909
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 30, 2018
Actual Primary Completion Date June 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Symptomatic peripheral arterial disease (PAD) involving the above-the-knee femoropopliteal arteries
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02254837
Other Study ID Numbers  ICMJE 12-005-PTX
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Cook Group Incorporated
Study Sponsor  ICMJE Cook Group Incorporated
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michael D Dake, MD Department of Cardiothoracic Surgery, Stanford University Medical Center, Stanford, CA
PRS Account Cook Group Incorporated
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP