CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 383 enrolled
Drug / intervention
Embol-X Embolic Protection Device +1 moredevice
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/NCT02389894
NCT02389894N/ACompleted
CompareCT.gov

Neuroprotection In Patients Undergoing Aortic Valve Replacement

Icahn School of Medicine at Mount Sinai·interventional·Posted Mar 17, 2015·Updated Apr 29, 2019

In Brief

A clinical study evaluating Embol-X Embolic Protection Device and CardioGard Cannula for Aortic Stenosis and 3 related conditions. Completed, enrolled 383 participants across 18 sites in 2 countries.

Detailed Summary

To evaluate the efficacy and safety of embolic protection devices to reduce ischemic brain injury in patients undergoing surgical aortic valve replacement (AVR).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAortic Stenosis, Brain Infarction, Cerebrovascular Accident, Stroke
CountriesCanada, United States
CollaboratorsNational Heart, Lung, and Blood Institute (NHLBI)

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedMar 17, 2015
Enrollment StartMar 1, 2015
Primary CompletionJan 1, 2017
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 11.3 years ago

Interventions

Embol-X Embolic Protection Devicedevice

per the manufacturer's instructions for use (IFU).

CardioGard Cannuladevice

CardioGard Cannula, per the manufacturer's instructions for use (IFU).