A Study to Look at Performance of MICRUSFRAME and GALAXY Coils for the Treatment of Intracranial Aneurysms



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:21 - 80
Updated:1/16/2019
Start Date:August 23, 2018
End Date:January 28, 2022
Contact:Lillian Ma
Email:lma46@its.jnj.com
Phone:9494668021

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Trial Summary
Trial Overview
Inclusion Criteria

A Prospective, Multi-center, Single Arm Study to Obtain "Real World" Clinical Data and Characterize the Acute and Long-term Performance of the MICRUSFRAME and GALAXY Coils for the Endovascular Treatment of Intracranial Aneurysms

A post-market registry evaluating ruptured/unruptured aneurysms treated exclusively with
Spectra Galaxy and Spectra Micrusframe coils

A registry to collect real world data on the use of Cerenovus coils. The study will be a
post-market registry evaluating ruptured/unruptured aneurysms treated exclusively with
Spectra Galaxy and Spectra Micrusframe coils

Inclusion Criteria:

1. Patient is between 21 and 80 years of age

2. Patient has an intracranial saccular aneurysm, ruptured or unruptured, suitable for
embolization with coils

3. Patient is able and willing to comply with protocol and follow-up requirements

Exclusion Criteria:

1. Patients in whom the planned procedure includes non Cerenovus coils

2. Pre-planned staged procedure

3. Fusiform aneurysm
We found this trial at
2
sites
Mount Sinai Hosp
New York, New York 10029
Principal Investigator: Reade De Leacy, MD
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from
New York, NY
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Mercy Health - St. Vincent Medical Center
Toledo, Ohio 43608
Principal Investigator: Osama Zaidat, MD, MS
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mi
from
Toledo, OH
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