CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 219 enrolled
Drug / intervention
MICHI NPS+fdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01685567
NCT01685567Phase 3Completed
CompareCT.gov

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

Silk Road Medical·interventional·Posted Sep 14, 2012·Updated Jul 7, 2017

In Brief

A Phase 3 clinical trial evaluating MICHI NPS+f for Carotid Artery Disease. Completed, enrolled 219 participants across 21 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCarotid Artery Disease
CountriesSpain, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedSep 14, 2012
Enrollment StartNov 1, 2012
Primary CompletionMar 1, 2016
Study CompletionJul 1, 2016
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 13.8 years ago

Interventions

MICHI NPS+fdevice

Cerebral protection with carotid flow reversal