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Zilver PTX Drug-Eluting Peripheral Stent Study

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ClinicalTrials.gov Identifier: NCT01348425
Recruitment Status : Completed
First Posted : May 5, 2011
Results First Posted : April 16, 2014
Last Update Posted : February 2, 2016
Sponsor:
Information provided by (Responsible Party):
Cook Group Incorporated

Brief Summary:
This randomized, post-market clinical study is intended to evaluate the delivery and deployment of longer Zilver PTX stents (≥ 100 mm) compared to shorter Zilver PTX stents (≤80 mm) for treatment of lesions of the above-the-knee femoropopliteal artery.

Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease Device: Longer Zilver PTX Stents Device: Shorter Zilver PTX Stents Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Zilver PTX Drug-Eluting Peripheral Stent
Study Start Date : May 2011
Actual Primary Completion Date : October 2011
Actual Study Completion Date : September 2012

Arm Intervention/treatment
Experimental: Longer Stents Device: Longer Zilver PTX Stents
Treatment with at least one 100 mm or longer Zilver PTX stent
Experimental: Shorter Stents Device: Shorter Zilver PTX Stents
Treatment with Zilver PTX stents 80 mm or shorter only



Primary Outcome Measures :
  1. Percent Change in Stent Length Upon Deployment [ Time Frame: During Procedure (day 1) (Prior to Stent Deployment and after Stent Deployment) ]


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

Inclusion Criteria:

  • One de novo or restenosed artherosclerotic lesion with > 50% diameter stenosis
  • Reference vessel diameter of 4 - 9 mm
  • Rutherford category ≥ 2
  • Resting ankle brachial index < 0.9

Exclusion Criteria:

  • Prior stent in the study vessel
  • Significant stenosis (> 50%) or occlusion of inflow tract not successfully treated before the study procedure
  • Lacks at least one patent runoff vessel
  • Lesions requiring atherectomy, cutting balloons, cryoplasty balloons, or any other advanced device to facilitate stent delivery

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): NCT01348425


Locations
Germany
Herz-Zentrum
Bad Krozingen, Germany, 79189
Evangelische Krankenhaus Königin Elisabeth Herzberge
Berlin, Germany, 10365
Universitätsklinikum Magdeburg A.ö.R.
Magdeburg, Germany, 39120
Switzerland
INSELSPITAL, Universitätsspital Bern
Berne, Switzerland, 3010
Sponsors and Collaborators
Cook Group Incorporated
Investigators
Principal Investigator: Prof. Dr. med. Jens Ricke Universitätsklinikum Magdeburg A.ö.R., Department for Radiology and Nuclear Medicine

Responsible Party: Cook Group Incorporated
ClinicalTrials.gov Identifier: NCT01348425     History of Changes
Other Study ID Numbers: 11-003
First Posted: May 5, 2011    Key Record Dates
Results First Posted: April 16, 2014
Last Update Posted: February 2, 2016
Last Verified: March 2014

Keywords provided by Cook Group Incorporated:
PAD

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