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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00196066
Other study ID # 02-513
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date October 2002
Est. completion date April 2006

Study information

Verified date May 2023
Source Cook Group Incorporated
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to assess the ability of a vascular stent to maintain an open iliac (leg) artery. The Zilver Vascular Stent is made of nitinol, a flexible metal with a long history of use in medical devices. The stent self-expands once inside the artery where it is intended to hold the vessel wall open. Within a few weeks, a layer of cells will grow over the stent helping to hold it in place.


Recruitment information / eligibility

Status Completed
Enrollment 150
Est. completion date April 2006
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 50 Years and older
Eligibility Inclusion Criteria: - Patient has documented stenotic or occluded atherosclerotic lesions of the external iliac or common iliac artery. - Patient has a de novo or restenotic lesion(s) with no prior stent in the target lesion. - Patient has given informed consent. Exclusion Criteria: - Patient is less than 50 years of age - Patient is participating in another investigational drug or device study. - Patient has multiple lesions (ipsilateral or in the aorta) that would require a staged procedure. - Patient has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions. - Patient has a known hypersensitivity or contraindication to aspirin, clopidogrel, nitinol, or contrast dye that cannot be adequately premedicated. - Patient is pregnant or breast-feeding.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Peripheral Vessel Stenting


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Cook Group Incorporated

References & Publications (2)

Jaff MR, Katzen BT. Two-year clinical evaluation of the Zilver vascular stent for symptomatic iliac artery disease. J Vasc Interv Radiol. 2010 Oct;21(10):1489-94. doi: 10.1016/j.jvir.2010.06.013. — View Citation

Krol KL, Saxon RR, Farhat N, Botti CF, Brown OW, Zemel G, Raabe RD, Voorhees WD 3rd, Katzen BT. Clinical evaluation of the Zilver vascular stent for symptomatic iliac artery disease. J Vasc Interv Radiol. 2008 Jan;19(1):15-22. doi: 10.1016/j.jvir.2007.08.031. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary The primary endpoint of the study is major adverse event (MAE) rate at the 9-month follow-up.
Secondary Additional endpoints include acute procedure and hemodynamic success, secondary patency, 9-month restenosis rate based on ultrasound examination, and 9-month functional status improvement.
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