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

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.

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Key information

Conditions

Peripheral Arterial Disease (PAD) Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Peripheral Arterial Disease Peripheral Vascular Diseases Vascular Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Peripheral Vessel Stenting

Device

Primary outcomes

The primary endpoint of the study is major adverse event (MAE) rate at the 9-month follow-up.

Secondary outcomes

Additional endpoints include acute procedure and hemodynamic success, secondary patency, 9-month restenosis rate based on ultrasound examination, and 9-month functional status improvement.

Sponsors and collaborators

Lead sponsor

Cook Group Incorporated

Industry

Registry information

Important dates

Study start: 2002
Study completion: 2006
First posted: Sep 20, 2005
Registry last updated: May 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed