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Zilver PTX Delivery System

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: NCT02271529
Recruitment Status : Completed
First Posted : October 22, 2014
Results First Posted : February 26, 2016
Last Update Posted : February 26, 2016
Sponsor:
Information provided by (Responsible Party):
Cook Group Incorporated

Brief Summary:
The objective of this study is to evaluate the performance of the Zilver PTX stent thumbwheel delivery system.

Condition or disease Intervention/treatment Phase
Peripheral Vascular Disease Device: Zilver® PTX® Drug-Eluting Peripheral Stent Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Zilver Paclitaxel(PTX) Thumbwheel Delivery System
Study Start Date : September 2014
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Drug Eluting Stent
Zilver® Paclitaxel(PTX)® Drug-Eluting Peripheral Stent
Device: Zilver® PTX® Drug-Eluting Peripheral Stent
Treatment of symptomatic vascular disease of the native above-the-knee femoropopliteal arteries.




Primary Outcome Measures :
  1. Mean Percent Change in Stent Length Upon Deployment [ Time Frame: Immediately following completion of the stent placement procedure ]


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:

  • Patient has symptomatic vascular disease of the native above-the-knee femoropopliteal arteries
  • Patient has atherosclerotic lesion of the above-the-knee femoropopliteal artery

Exclusion Criteria:

  • Patient is < 18 years of age
  • Patient unable to complete required follow-up assessments
  • Patient unwilling to sign and date the informed consent
  • Simultaneous participation in another investigational drug or device study
  • Pregnant, breastfeeding or planning to become pregnant in the next 5 years
  • Additional medical/anatomical restrictions as specified in the Clinical Investigation Plan

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): NCT02271529


Locations
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Australia
Frankston Hospital
Frankston, Australia, Vic 3199
Princess Alexandra Hospital
Woolloongabba, Australia, Qld 4102
Germany
Universitäts-Herzzentrum Freiburg - Bad Krozingen GmbH
Bad Krozingen, Germany, D-79189
New Zealand
Auckland City Hospital
Auckland, New Zealand, 1023
Waikato Hospital
Hamilton, New Zealand, 3248
Wellington Hospital
Wellington, New Zealand, 3248
Sponsors and Collaborators
Cook Group Incorporated
Investigators
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Principal Investigator: Andrew Holden, MD Auckland District Health Board
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Responsible Party: Cook Group Incorporated
ClinicalTrials.gov Identifier: NCT02271529    
Other Study ID Numbers: 13-14
First Posted: October 22, 2014    Key Record Dates
Results First Posted: February 26, 2016
Last Update Posted: February 26, 2016
Last Verified: January 2016
Keywords provided by Cook Group Incorporated:
Peripheral Vascular Disease
Femoral Artery
Drug-Eluting Stent
Additional relevant MeSH terms:
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Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases