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NCT01348425 Clinical Trial

Zilver PTX Drug-Eluting Peripheral Stent Study

Peripheral Arterial Disease Clinical Trial

Official title:
Evaluation of the Zilver PTX Drug-Eluting Peripheral Stent

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01348425
Other study ID # 11-003
Secondary ID
Status Completed
Phase N/A
First received April 29, 2011
Last updated December 29, 2015
Start date May 2011
Est. completion date September 2012

Study information
Verified date March 2014
Source Cook
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics CommissionSwitzerland: Ethikkommission
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 45
Est. completion date September 2012
Est. primary completion date October 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• Longer Zilver PTX Stents
Treatment with at least one 100 mm or longer Zilver PTX stent
• Shorter Zilver PTX Stents
Treatment with Zilver PTX stents 80 mm or shorter only

Locations
Country Name City State
Germany Herz-Zentrum Bad Krozingen
Germany Evangelische Krankenhaus Königin Elisabeth Herzberge Berlin
Germany Universitätsklinikum Magdeburg A.ö.R. Magdeburg
Switzerland INSELSPITAL, Universitätsspital Bern Berne

Sponsors (1)
Lead Sponsor Collaborator
Cook

Countries where clinical trial is conducted

Germany,  Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percent Change in Stent Length Upon Deployment During Procedure (day 1) (Prior to Stent Deployment and after Stent Deployment) No
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