TARGET Intracranial Aneurysm Coiling Registry



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:7/26/2018
Start Date:February 2013
End Date:March 2019
Contact:Victoria J Calderon, MPH
Email:vcalderon@mercy.com
Phone:4192514367

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TARGET Intracranial Aneurysm Coiling Registry: A Prospective Clinical Efficacy and Safety Study of Stryker Target® 360°, Target® Helical, and 2nd Generation Target® Nano Coils

The purpose of this prospective registry is to collect real world, post-marketing data on the
use of Stryker Target® 360,Target® 2D, and 2nd generation Target® Nano coils for the
embolization of ruptured or unruptured intracranial saccular aneurysms. Up to 300 patients
(150 in the TARGET 360°/Helical arm and 150 in the New NANO arm) presenting with intracranial
aneurysms suitable for coil embolization will be enrolled at up to 20 sites. A post hoc
analysis comparing Target® 360° and Target® 2D coil technical and clinical endpoints will be
performed.


Inclusion Criteria:

1. Patient is 18 years or older.

2. Patient has a documented, previously untreated, saccular intracranial aneurysm,
unruptured or ruptured, suitable for embolization with coils.

3. (NEW NANO arm ONLY) Target aneurysm is ≤7mm.

4. Patient has a Hunt and Hess Score of 3 or less.

5. Patient has a premorbid mRS of 3 or less.

6. Patient or patient's legally authorized representative has provided written informed
consent.

7. Patient is willing to and can comply with study follow-up requirements.

Exclusion Criteria:

1. Patient is < 18 years old.

2. Dissecting aneurysm.

3. Patients with intracranial aneurysms (other than the target aneurysm) that will
require treatment during the study period (enrollment through follow-up).

4. Patients in whom the target aneurysm will be treated with coils other than Stryker
Target® 360°, Target® Helical coils, and 2nd generation Target® Nano Coils.

5. (NEW NANO Arm ONLY) Patients in whom the target aneurysm was treated with a total coil
length comprised of <25% Stryker Target® 2nd generation Nano Coils.

6. Target aneurysm is fusiform.

7. Patients in which the target aneurysm cannot be coiled in one procedure (i.e. staged
procedure)
We found this trial at
9
sites
Flint, Michigan 48532
Principal Investigator: Aniel Q Majjhoo, MD
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Flint, MI
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Greenville, South Carolina 29615
Principal Investigator: Mahmoud Rayes, MD
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Greenville, SC
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Joliet, Illinois 60435
Principal Investigator: Aamir Badruddin, MD
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Joliet, IL
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Morgantown, West Virginia
Principal Investigator: Ansaar Rai, MD
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Morgantown, WV
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550 East Van Buren Street
Phoenix, Arizona 85004
Principal Investigator: Peter J Sunenshine, MD
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Phoenix, AZ
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Saint Louis, Missouri 63132
Principal Investigator: Amer Alshekhlee, MD
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Saint Louis, MO
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Tallahassee, Florida 32308
Principal Investigator: Matthew Lawson, MD
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Tallahassee, FL
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Toledo, Ohio 43608
Principal Investigator: Osama O Zaidat, MD, MS
Phone: 419-251-4367
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Toledo, OH
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55 N Lake Ave
Worcester, Massachusetts 01655
(508) 856-8989
Principal Investigator: Ajit Puri, MD
Univ of Massachusetts Med School As the commonwealth's only public medical school, we take seriously...
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Worcester, MA
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