Evaluation of the Zilver Vascular Stent in the Iliac Arteries (ZIPS)

Peripheral Arterial Disease (PAD) Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00196066
• Other study ID #: 02-513
• Status: Completed
• Phase: Phase 2
• 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
• 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
• 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.

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Arterial Disease (PAD)
• Peripheral Vascular Diseases

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.