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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

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.

Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease Peripheral Vascular Disease Device: Zilver® PTX™ Stent Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 788 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : April 2006
Actual Primary Completion Date : January 2009
Actual Study Completion Date : April 2011

Arm Intervention/treatment
Experimental: Stent Device: Zilver® PTX™ Stent
Stenting of the superfemoropopliteal artery.




Primary Outcome Measures :
  1. Event-free Survival [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT01094678


Locations
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Germany
Heart Center Leipzig, Angiology
Leipzig, Germany, 04289
St. Franziskus Hospital Munster
Munster, Germany, 48145
Universitat Klinik Tubingen
Tubingen, Germany, 72072
Italy
University of Roma La Sapienza
Rome, Italy, 00161
Sponsors and Collaborators
Cook Group Incorporated
Investigators
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Principal Investigator: Michael Dake, MD Stanford University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Cook Group Incorporated
ClinicalTrials.gov Identifier: NCT01094678     History of Changes
Other Study ID Numbers: 05-518
100010 ( Other Identifier: Cook )
First Posted: March 29, 2010    Key Record Dates
Last Update Posted: September 11, 2014
Last Verified: September 2014

Keywords provided by Cook Group Incorporated:
Peripheral Aterial Disease (PAD)
Peripheral Vascular Disease
Drug-Eluting Stent
Drug-Coated Stent
Vascular Diseases
Cardiovascular Diseases

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