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Zilver® PTX™ Global Registry

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ClinicalTrials.gov Identifier: NCT01094678
Recruitment Status : Completed
First Posted : March 29, 2010
Last Update Posted : September 11, 2014
Sponsor:
Information provided by (Responsible Party):
Cook Group Incorporated

Tracking Information
First Submitted Date  ICMJE March 25, 2010
First Posted Date  ICMJE March 29, 2010
Last Update Posted Date September 11, 2014
Study Start Date  ICMJE April 2006
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 26, 2010)
Event-free Survival [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01094678 on ClinicalTrials.gov Archive Site
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™ Global Registry
Official Title  ICMJE Evaluation of the Safety and Performance of the Zilver® PTX™ Drug-Eluting Stent for Treating De Novo or Restenotic Lesions of the Above-the-knee Femoropopliteal Artery
Brief Summary The Zilver PTX Registry Study is a prospective, non-randomized, open-label, multicenter single-arm study enrolling patients in Europe, Asia, and North America with de novo or restenotic (including in-stent restenosis) lesions of the above-the-knee femoropopliteal artery (SFA). The primary endpoint of the study is event-free survival (EFS) at 6 months.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Peripheral Arterial Disease
  • Peripheral Vascular Disease
Intervention  ICMJE Device: Zilver® PTX™ Stent
Stenting of the superfemoropopliteal artery.
Study Arms  ICMJE Experimental: Stent
Intervention: Device: Zilver® PTX™ 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: January 30, 2012)
788
Original Estimated Enrollment  ICMJE
 (submitted: March 26, 2010)
800
Actual Study Completion Date  ICMJE April 2011
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • stenosis of the above-the-knee femoropopliteal artery
  • appropriate size and location of the lesion

Exclusion Criteria:

  • pregnant or breast feeding
  • failure or inability to give informed consent
  • simultaneously participating in another drug or device study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (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 Germany,   Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01094678
Other Study ID Numbers  ICMJE 05-518
100010 ( Other Identifier: Cook )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
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 Dake, MD Stanford University
PRS Account Cook Group Incorporated
Verification Date September 2014

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