Zilver PTX Drug-Eluting Peripheral Stent Study

This study has been completed.
Information provided by (Responsible Party):
ClinicalTrials.gov Identifier:
First received: April 29, 2011
Last updated: March 11, 2014
Last verified: March 2014

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 Intervention
Peripheral Arterial Disease
Device: Longer Zilver PTX Stents
Device: Shorter Zilver PTX Stents

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of the Zilver PTX Drug-Eluting Peripheral Stent

Resource links provided by NLM:

Further study details as provided by Cook:

Primary Outcome Measures:
  • Percent Change in Stent Length Upon Deployment [ Time Frame: During Procedure (day 1) (Prior to Stent Deployment and after Stent Deployment) ] [ Designated as safety issue: No ]

Enrollment: 45
Study Start Date: May 2011
Study Completion Date: September 2012
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01348425

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

No publications provided

Responsible Party: Cook
ClinicalTrials.gov Identifier: NCT01348425     History of Changes
Other Study ID Numbers: 11-003
Study First Received: April 29, 2011
Results First Received: July 25, 2013
Last Updated: March 11, 2014
Health Authority: Germany: Ethics Commission
Switzerland: Ethikkommission

Keywords provided by Cook:

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

ClinicalTrials.gov processed this record on April 17, 2014