TARGET Intracranial Aneurysm Coiling Registry

• Conditions: Intracranial Aneurysms
• Interventions: Device: Target 360°, 2D Coils, Nano Coils

• Registration Number: NCT01748903
• Lead Sponsor: Mercy Health Ohio

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-12-07
• Study First Submitted QC: 2012-12-12
• Study First Posted: 2012-12-13
• Study Start: 2013-02
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-20
• Last Update Posted: 2018-07-24
• Primary Completion: 2019-01
• Study Completion: 2019-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Packing Density	At immediate post-procedure (Day 1)	Packing density will be calculated based on aneurysm volume and amount of coil used during the embolization procedure.

Secondary Outcome Measures

Name	Time	Method
Aneurysm Re-access Rate	At end of study procedure (Day 1)	The rate of re-assess (Microcatheter kick-back rate) of the target aneurysm will be captured during the procedure.
Modified Rankin Score	At baseline (Day 1) and hospital discharge (Day 3) and 3-9 month follow-up	Modified Rankin score will be recorded at baseline, hospital discharge, and during the 3-9 month follow-up.
Occlusion Rate	At immediate post-procedure (Day 1) and 3-9 month follow-up	Angiographic occlusion of the aneurysm will be adjudicated by an independent core lab using immediate post-procedure and 3-9 month follow-up angiography.
Time of Fluoroscopic Exposure	At immediate post-procedure (Day 1)	Total time of fluoroscopic exposure will be captured from the initial recording of the road map to the final angiogram after completion of the coil embolization procedure.
Treatment-related Morbidity and Mortality	from study procedure (Day 1) to 3-9 month follow-up	Treatment-related morbidity and morality will be tracked and recorded from study procedure through the 3-9 month follow-up.
Device-related serious adverse events	From the study procedure (Day 1) until 3-9 month follow up	Procedural and post-procedural serious adverse events related to the device and/or procedure will be captured and recorded at the end of the procedure and until the patient has completed the 3-9 month follow-up.
Length of hospital stay	At hospital discharge (Day 3)	Length of hospital stay will be recorded at the time of patient discharge.
Overall Procedure Time	At Immediate post-procedure (Day 1)	The overall procedure time will be captured from the time of guide catheter placement to the end of the coil embolization procedure.
Aneurysm Recurrence	3-9 month follow-up
Aneurysm Re-treatment Rate	3-9 month follow-up	Aneurysm re-treatment rates will be tracked and recorded during the 3-9 month follow-up
Aneurysm Bleed and Re-bleed Rate	3-9 month follow-up	Aneurysm Bleed and Re-bleed Rate will be assessed and recorded at the 3-9 month follow-up.
Technical and clinical endpoints of Target 360° and 2D coils	3-9 month follow-up	A post hoc analysis comparing Target 360° and 2D coil primary and secondary technical and clinical endpoints will be performed upon final data analysis.

Trial Locations

Locations (9)

McLaren Health; 🇺🇸 Flint, Michigan, United States

West Virginia University Hospital; 🇺🇸 Morgantown, West Virginia, United States

SSM DePaul Health Center; 🇺🇸 Saint Louis, Missouri, United States

Tallahassee Neurological Clinic; 🇺🇸 Tallahassee, Florida, United States

University of Massachusetts Medical School; 🇺🇸 Worcester, Massachusetts, United States

Mercy Health St. Vincent Medical Center; 🇺🇸 Toledo, Ohio, United States

Presence Saint Joseph Medical Center; 🇺🇸 Joliet, Illinois, United States

Greenville Health System; 🇺🇸 Greenville, South Carolina, United States

University of Arizona; 🇺🇸 Phoenix, Arizona, United States