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Safety and Efficacy Study for Reverse Flow Used During Carotid Artery Stenting Procedure

NCT01685567 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 219

Last updated 2017-07-07

Study results available
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Summary

The purpose of this study is to obtain and establish the safety and efficacy of The MICHI™ Neuroprotection System with Filter (MICHI™ NPS+f) for providing cerebral embolic protection during angioplasty and stenting procedures in carotid arteries. The MICHI NPS+f also facilitates access to the carotid and neuro anatomy for the introduction of therapeutic or diagnostic endovascular devices and/or agents. It will be used in conjunction with a FDA approved carotid artery stent for the treatment of carotid artery disease.

Conditions

  • Carotid Artery Disease

Interventions

DEVICE

MICHI NPS+f

Cerebral protection with carotid flow reversal

Sponsors & Collaborators

  • Silk Road Medical

    lead INDUSTRY

Principal Investigators

  • Christopher Kwolek, MD · Massachusetts General Hospital

  • Richard Cambria, MD · Massachusetts General Hospital

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2016-03-31
Completion
2016-07-31

Countries

  • United States
  • Spain

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 NCT01685567 on ClinicalTrials.gov