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Zilver PTX Drug-Eluting Peripheral Stent Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cook
ClinicalTrials.gov Identifier:
NCT01348425
First received: April 29, 2011
Last updated: March 12, 2013
Last verified: March 2013
History of Changes
  Purpose

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:

U.S. FDA Resources

Further study details as provided by Cook:

Primary Outcome Measures:
  • 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
Investigators
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
Last Updated: March 12, 2013
Health Authority: Germany: Ethics Commission
Switzerland: Ethikkommission

Keywords provided by Cook:
PAD

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

ClinicalTrials.gov processed this record on May 23, 2013