TARGET Intracranial Aneurysm Coiling Registry

NCT ID: NCT01748903

Last Updated: 2018-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-02-28

Study Completion Date

2019-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Intracranial Aneurysms

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Target 360°, 2D, Nano Coils

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

Target 360°, 2D Coils, Nano Coils

Intervention Type DEVICE

Interventions

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Target 360°, 2D Coils, Nano Coils

Intervention Type DEVICE

Other Intervention Names

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Target coils Target Nano coil

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stryker Neurovascular

INDUSTRY

Sponsor Role collaborator

Mercy Health Ohio

OTHER

Sponsor Role lead

Responsible Party

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Dr. Osama O. Zaidat

Medical Director, Neuroscience and Stroke Programs

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Osama O Zaidat, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Mercy Health St. Vincent Medical Center

Locations

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University of Arizona

Phoenix, Arizona, United States

Site Status RECRUITING

Tallahassee Neurological Clinic

Tallahassee, Florida, United States

Site Status RECRUITING

Presence Saint Joseph Medical Center

Joliet, Illinois, United States

Site Status RECRUITING

University of Massachusetts Medical School

Worcester, Massachusetts, United States

Site Status RECRUITING

McLaren Health

Flint, Michigan, United States

Site Status RECRUITING

SSM DePaul Health Center

St Louis, Missouri, United States

Site Status RECRUITING

Mercy Health St. Vincent Medical Center

Toledo, Ohio, United States

Site Status RECRUITING

Greenville Health System

Greenville, South Carolina, United States

Site Status RECRUITING

West Virginia University Hospital

Morgantown, West Virginia, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Victoria J Calderon, MPH

Role: CONTACT

4192514367

Facility Contacts

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Victoria J Calderon, MPH

Role: primary

419-251-4367

References

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Zaidat OO, Castonguay AC, Rai AT, Badruddin A, Mack WJ, Alshekhlee AK, Shah QA, Hussain SI, Kabbani MR, Bulsara KR, Taqi AM, Janardhan V, Patterson MS, Nordhaus BL, Elijovich L, Puri AS. TARGET(R) Intracranial Aneurysm Coiling Prospective Multicenter Registry: Final Analysis of Peri-Procedural and Long-Term Safety and Efficacy Results. Front Neurol. 2019 Jul 9;10:737. doi: 10.3389/fneur.2019.00737. eCollection 2019.

Reference Type DERIVED
PMID: 31338061 (View on PubMed)

Other Identifiers

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19180

Identifier Type: -

Identifier Source: org_study_id

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