Recruiting

Observational Study

Sponsor:

Mercy Health Ohio

Code:

NCT01748903

Conditions

Intracranial Aneurysms

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Target 360°, 2D Coils, Nano Coils

Study Details

Brief summary:

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.

Conditions

Intracranial Aneurysms

Study ID

NCT01748903

Start date

Feb, 2013

Status verified date

Jul, 2018

Completion date

Mar, 2019

Anticipated

Primary completion date

Jan, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

150 participants

Anticipated

Interventions and Outcome Measures

Arms

Target 360°, 2D, Nano Coils

Subjects will undergo embolization using Target 360°, 2D, Nano Coils for the treatment of their intracranial aneurysm.

Interventions

Target 360°, 2D Coils, Nano Coils

Primary outcome measure

  • Packing Density [ Time Frame: At immediate post-procedure (Day 1) ]

Central Contacts and Locations

Central contacts

Victoria J Calderon, MPH

4192514367vcalderon@mercy.com

Locations

University of Arizona

Recruiting

Phoenix, Arizona, United States, 85006

Principal Investigator:

Peter J Sunenshine, MD

Tallahassee Neurological Clinic

Recruiting

Tallahassee, Florida, United States, 32308

Principal Investigator:

Matthew Lawson, MD

Presence Saint Joseph Medical Center

Recruiting

Joliet, Illinois, United States, 60435

Principal Investigator:

Aamir Badruddin, MD

University of Massachusetts Medical School

Recruiting

Worcester, Massachusetts, United States, 01655

Principal Investigator:

Ajit Puri, MD

McLaren Health

Recruiting

Flint, Michigan, United States, 48532

Principal Investigator:

Aniel Q Majjhoo, MD

SSM DePaul Health Center

Recruiting

Saint Louis, Missouri, United States, 63132

Principal Investigator:

Amer Alshekhlee, MD

Mercy Health St. Vincent Medical Center

Recruiting

Toledo, Ohio, United States, 43604

Contacts

Victoria J Calderon, MPH

419-251-4367vcalderon@mercy.com

Principal Investigator:

Osama O Zaidat, MD, MS

Greenville Health System

Recruiting

Greenville, South Carolina, United States, 29605

Principal Investigator:

Mahmoud Rayes, MD

West Virginia University Hospital

Recruiting

Morgantown, West Virginia, United States, 26505

Principal Investigator:

Ansaar Rai, MD

More Information

Sponsor

Mercy Health Ohio

Last update posted

Jul 24, 2018

Last verified

Jul, 2018

Keywords

  • intracranial aneurysm
  • cerebral aneurysm
  • packing density
  • Target Coils
  • aneurysm embolization

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Mercy Health Ohio on 2018-07-24.