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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-10-31

Study Completion Date

2006-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study to Evaluate the Safety & Performance of the Xpert(TM) Stent in Treating Below-the-knee Lesions in Patients Undergoing Percutaneous Intervention for Chronic CLI.

NCT00515346

Chronic Critical Limb Ischemia Peripheral Vascular Diseases

COMPLETED PHASE1

Sirolimus-Eluting Versus Paclitaxel-Eluting Stents for Coronary Revascularization

NCT00297661

Coronary Heart Disease

COMPLETED PHASE4

RRISC Study: Reduction of Restenosis In Saphenous Vein Grafts With Cypher Sirolimus-Eluting Stent.

NCT00263263

Stable Angina Unstable Angina Coronary Artery Disease +1 more

COMPLETED PHASE2

Double or Single Dose Sirolimus-Eluting Stents in Diabetic Patients With de Novo Coronary Artery Lesions

NCT00233714

Coronary Artery Disease

COMPLETED PHASE1/PHASE2

Efficacy of Balloon-Expandable Stent Versus Self-Expandable Stent for the Atherosclerotic ILIAC Arterial Disease

NCT01834495

Peripheral Artery Disease Atherosclerosis

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Peripheral Arterial Disease (PAD)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Peripheral Vessel Stenting

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No