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GORE Flow Reversal System and GORE Embolic Filter Extension Study

NCT01343667 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1397

Last updated 2016-02-19

Study results available
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Summary

The objective of this study is to provide an ongoing evaluation of clinical outcomes associated with the GORE Flow Reversal System and the GORE Embolic Filter when used for embolic protection during carotid artery stenting.

Conditions

  • Carotid Stenosis
  • Constriction, Pathologic
  • Carotid Artery Diseases
  • Cerebrovascular Disorders
  • Brain Diseases
  • Central Nervous System Diseases
  • Nervous System Diseases
  • Arterial Occlusive Diseases
  • Vascular Diseases
  • Cardiovascular Diseases
  • Pathological Conditions, Anatomical

Interventions

DEVICE

Gore Flow Reversal System

Embolic protection by the GORE Flow Reversal System during carotid artery angioplasty and stenting

DEVICE

Gore Embolic Filter

Embolic protection by the GORE Embolic Filter during carotid artery angioplasty and stenting

Sponsors & Collaborators

  • W.L.Gore & Associates

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2013-11-30
Completion
2014-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT01343667 on ClinicalTrials.gov