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A Single Center of Carotid Stenting With Distal Protection for the Treatment of Obstructive Carotid Artery Disease

NCT00178672 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2020-11-05

No results posted yet for this study

Summary

The primary objective of this study is to assess the safety and effectiveness of stenting in the treatment of obstructive carotid artery disease. Secondary objectives are the assessment and standardization of optimal operator techniques and successful deployment and retrieval of the AngioGuard XP Distal Protection Device. This is a single center, prospective, open-label feasibility study. The study population will consist of patients with atherosclerotic obstructive or post-endarterectomy restenotic lesions in native carotid arteries. The intention is to include patients with both types of lesions.

Conditions

  • Heart Disease
  • Brain Vascular Accident
  • Carotid Artery Disease
  • Carotid Stenosis

Interventions

DEVICE

Angioguard XP distal protection device

Standard of care stenting of carotid arteries protocol is used.

PROCEDURE

Heart Catheterization -Angioplasty

Standard of care carotid stenting. A catheter is inserted in the femoral vein into the carotid artery where a balloon is inflated and shortly thereafter a stent is placed in the target lesion area.

DEVICE

stenting

stenting of carotid arteries

Sponsors & Collaborators

  • Johnson & Johnson

    collaborator INDUSTRY

  • The University of Texas Health Science Center, Houston

    lead OTHER

Principal Investigators

  • Richard W Smalling, MD,PhD · The University of Texas Health Science Center, Houston

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-11-30
Completion
2007-08-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00178672 on ClinicalTrials.gov