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Completed Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT01685567

Public ClinicalTrials.gov record NCT01685567. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 5, 2026, 10:48 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

INVESTIGATION of FLOW ALTERED, SHORT TRANSCERVICAL CAROTID ARTERY STENTING in PATIENTS With SIGNIFICANT CAROTID ARTERY DISEASE With Filter.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT01685567
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Silk Road Medical
Industry
Enrollment
219 participants

Conditions and interventions

Interventions

Device

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Oct 31, 2012
Primary completion
Feb 29, 2016
Completion
Jun 30, 2016
Last update posted
Jul 6, 2017

2012 – 2016

United States locations

U.S. sites
20
U.S. states
12
U.S. cities
18
Facility City State ZIP Site status
Peter Morton UCLA Medical Center Los Angeles California 90095
Florida Hospital Orlando Florida 32804
Johns Hopkins Bayview Medical Center Baltimore Maryland 21224
Massachusetts General Hospital Boston Massachusetts 02114
University of Michigan Medical Center Ann Arbor Michigan 48109-5967
McLaren Regional Medical Center Flint Michigan 48507
Washington University School of Medicine St Louis Missouri 63110
Albany Medical Center Albany New York 12208
University at Buffalo Neurosurgery, Inc Buffalo New York 14203
Columbia University New York New York 10032
Cleveland Clinic Foundation Cleveland Ohio 44106
University Hospitals Case Medical Center and Case Western Reserve University School of Medicine Cleveland Ohio 44106
Riverside Methodist Hospital Columbus Ohio 43214
Jobst Vascular Institute Toledo Ohio 43606
Oklahoma Heart Oklahoma City Oklahoma 73120
Greenville Hospital System Greenville South Carolina 29615
Cardiothoracic & Vascular Surgeons Austin Texas 78756
Methodist Medical Center Dallas Texas 75208
Dallas VA Medical Center Dallas Texas 75216
Sentara Vascular Specialists Norfolk Virginia 23507

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01685567, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 6, 2017 · Synced Sep 5, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01685567 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →