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Evaluation of the Roadsaver Stent Used in Conjunction With the Nanoparasol Embolic Protection System for Carotid Artery Stenosis

NCT02657707 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 295

Last updated 2023-02-28

No results posted yet for this study

Summary

A prospective, multicenter, single-arm, open label clinical study to evaluate the safety and effectiveness of MicroVention, Inc. Roadsaver™ Carotid Stent System used in conjunction with the Nanoparasol® embolic protection system for the treatment of carotid artery stenosis in patients with elevated risk for adverse events following carotid endarterectomy.

Conditions

  • Carotid Artery Stenosis

Interventions

DEVICE

Roadsaver™ Carotid Artery Stent Device

The Roadsaver™ carotid artery stent system is indicated for use in patients with significant atherosclerotic disease of the carotid arteries.

DEVICE

Nanoparasol® Embolic Protection System

The Nanoparasol® embolic protection system is indicated for use with a guidewire to contain and remove embolic material (thrombus/debris) while performing angioplasty and stenting procedures in carotid arteries.

Sponsors & Collaborators

  • Microvention-Terumo, Inc.

    lead INDUSTRY

Principal Investigators

  • Adnan Siddiqui, MD · University of Buffalo - Neurosurgery

  • Chris Metzger, MD · Wellmont CVA Heart Institute

  • Peter Schneider, MD · Kaiser Permanente Moanalua Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-21
Primary Completion
2022-04-08
Completion
2024-05-31

Countries

  • United States

Study Locations

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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 NCT02657707 on ClinicalTrials.gov