Zilver PTX Drug-Eluting Peripheral Stent Study
Evaluation of the Zilver PTX Drug-Eluting Peripheral Stent
1 other identifier
interventional
45
2 countries
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2011
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 29, 2011
CompletedStudy Start
First participant enrolled
May 1, 2011
CompletedFirst Posted
Study publicly available on registry
May 5, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2012
CompletedResults Posted
Study results publicly available
April 16, 2014
CompletedFebruary 2, 2016
March 1, 2014
5 months
April 29, 2011
July 25, 2013
December 29, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percent Change in Stent Length Upon Deployment
During Procedure (day 1) (Prior to Stent Deployment and after Stent Deployment)
Study Arms (2)
Longer Stents
EXPERIMENTALShorter Stents
EXPERIMENTALInterventions
Treatment with at least one 100 mm or longer Zilver PTX stent
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Herz-Zentrum
Bad Krozingen, 79189, Germany
Evangelische Krankenhaus Königin Elisabeth Herzberge
Berlin, 10365, Germany
Universitätsklinikum Magdeburg A.ö.R.
Magdeburg, 39120, Germany
INSELSPITAL, Universitätsspital Bern
Bern, 3010, Switzerland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Scott Snyder, PhD, Director of Clinical Science and Biostatistics
- Organization
- Cook
Study Officials
- PRINCIPAL INVESTIGATOR
Prof. Dr. med. Jens Ricke
Universitätsklinikum Magdeburg A.ö.R., Department for Radiology and Nuclear Medicine
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 29, 2011
First Posted
May 5, 2011
Study Start
May 1, 2011
Primary Completion
October 1, 2011
Study Completion
September 1, 2012
Last Updated
February 2, 2016
Results First Posted
April 16, 2014
Record last verified: 2014-03