TARGET Intracranial Aneurysm Coiling Registry

Intracranial Aneurysms Clinical Trial

— TARGET  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01748903
• Other study ID #: 19180
• Status: Recruiting
• Start date: February 2013
• Est. completion date: March 2019

Study information

• Verified date: July 2018
• Source: Mercy Health Ohio
• Contact: Victoria J Calderon, MPH
• Phone: 4192514367
• Email: vcalderon[@]mercy.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: March 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Aneurysm
• Intracranial Aneurysm
• Intracranial Aneurysms

Intervention

Device:
• Target 360°, 2D Coils, Nano Coils

Locations

Country	Name	City	State
United States	McLaren Health	Flint	Michigan
United States	Greenville Health System	Greenville	South Carolina
United States	Presence Saint Joseph Medical Center	Joliet	Illinois
United States	West Virginia University Hospital	Morgantown	West Virginia
United States	University of Arizona	Phoenix	Arizona
United States	SSM DePaul Health Center	Saint Louis	Missouri
United States	Tallahassee Neurological Clinic	Tallahassee	Florida
United States	Mercy Health St. Vincent Medical Center	Toledo	Ohio
United States	University of Massachusetts Medical School	Worcester	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Mercy Health Ohio	Stryker Neurovascular

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Packing Density	Packing density will be calculated based on aneurysm volume and amount of coil used during the embolization procedure.	At immediate post-procedure (Day 1)
Secondary	Occlusion Rate	Angiographic occlusion of the aneurysm will be adjudicated by an independent core lab using immediate post-procedure and 3-9 month follow-up angiography.	At immediate post-procedure (Day 1) and 3-9 month follow-up
Secondary	Aneurysm Re-access Rate	The rate of re-assess (Microcatheter kick-back rate) of the target aneurysm will be captured during the procedure.	At end of study procedure (Day 1)
Secondary	Time of Fluoroscopic Exposure	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.	At immediate post-procedure (Day 1)
Secondary	Overall Procedure Time	The overall procedure time will be captured from the time of guide catheter placement to the end of the coil embolization procedure.	At Immediate post-procedure (Day 1)
Secondary	Aneurysm Recurrence		3-9 month follow-up
Secondary	Aneurysm Re-treatment Rate	Aneurysm re-treatment rates will be tracked and recorded during the 3-9 month follow-up	3-9 month follow-up
Secondary	Aneurysm Bleed and Re-bleed Rate	Aneurysm Bleed and Re-bleed Rate will be assessed and recorded at the 3-9 month follow-up.	3-9 month follow-up
Secondary	Treatment-related Morbidity and Mortality	Treatment-related morbidity and morality will be tracked and recorded from study procedure through the 3-9 month follow-up.	from study procedure (Day 1) to 3-9 month follow-up
Secondary	Modified Rankin Score	Modified Rankin score will be recorded at baseline, hospital discharge, and during the 3-9 month follow-up.	At baseline (Day 1) and hospital discharge (Day 3) and 3-9 month follow-up
Secondary	Device-related serious adverse events	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.	From the study procedure (Day 1) until 3-9 month follow up
Secondary	Length of hospital stay	Length of hospital stay will be recorded at the time of patient discharge.	At hospital discharge (Day 3)
Secondary	Technical and clinical endpoints of Target 360° and 2D coils	A post hoc analysis comparing Target 360° and 2D coil primary and secondary technical and clinical endpoints will be performed upon final data analysis.	3-9 month follow-up