TARGET Intracranial Aneurysm Coiling Registry (TARGET)

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.

Study Overview

• Status: Unknown
• Conditions: Intracranial Aneurysms
• Intervention / Treatment: Device: Target 360°, 2D Coils, Nano Coils

• Study Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

• Study Contact: Name: Victoria J Calderon, MPH; Phone Number: 4192514367; Email: vcalderon@mercy.com

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • Recruiting
      • University of Arizona
      • Principal Investigator: Peter J Sunenshine, MD
  • Florida
    • Tallahassee, Florida, United States, 32308
      • Recruiting
      • Tallahassee Neurological Clinic
      • Principal Investigator: Matthew Lawson, MD
      • Sub-Investigator: Narlin Beaty, MD
      • Principal Investigator: T. Adam Oliver, MD
  • Illinois
    • Joliet, Illinois, United States, 60435
      • Recruiting
      • Presence Saint Joseph Medical Center
      • Principal Investigator: Aamir Badruddin, MD
  • Massachusetts
    • Worcester, Massachusetts, United States, 01655
      • Recruiting
      • University of Massachusetts Medical School
  • Michigan
    • Flint, Michigan, United States, 48532
      • Recruiting
      • McLaren Health
      • Principal Investigator: Aniel Q Majjhoo, MD
      • Sub-Investigator: Bharath R Naravetla, MD
  • Missouri
    • Saint Louis, Missouri, United States, 63132
      • Recruiting
      • SSM DePaul Health Center
      • Principal Investigator: Amer Alshekhlee, MD
      • Sub-Investigator: Richard Callison, MD
  • Ohio
    • Toledo, Ohio, United States, 43604
      • Recruiting
      • Mercy Health St. Vincent Medical Center
      • Principal Investigator: Osama O Zaidat, MD, MS
      • Contact: Victoria J Calderon, MPH; Phone Number: 419-251-4367; Email: vcalderon@mercy.com
  • South Carolina
    • Greenville, South Carolina, United States, 29605
      • Recruiting
      • Greenville Health System
      • Principal Investigator: Mahmoud Rayes, MD
  • West Virginia
    • Morgantown, West Virginia, United States, 26505
      • Recruiting
      • West Virginia University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All sequential patients presenting with unruptured and ruptured saccular aneurysms, who meet all eligibility criteria, will be considered for study enrollment.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Target 360°, 2D, Nano Coils; Subjects will undergo embolization using Target 360°, 2D, Nano Coils for the treatment of their intracranial aneurysm.	Device: Target 360°, 2D Coils, Nano Coils; Other Names: Target coils; Target Nano coil

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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)
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)
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)
Aneurysm Recurrence		3-9 month follow-up
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
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
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
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
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
Length of hospital stay	Length of hospital stay will be recorded at the time of patient discharge.	At hospital discharge (Day 3)
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

Collaborators and Investigators

• Sponsor: Mercy Health Ohio
• Collaborators: Stryker Neurovascular
• Investigators: Principal Investigator: Osama O Zaidat, MD, MS, Mercy Health St. Vincent Medical Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Anticipated): January 1, 2019
• Study Completion (Anticipated): March 1, 2019

Study Registration Dates

• First Submitted: December 7, 2012
• First Submitted That Met QC Criteria: December 12, 2012
• First Posted (Estimate): December 13, 2012

Study Record Updates

• Last Update Posted (Actual): July 24, 2018
• Last Update Submitted That Met QC Criteria: July 20, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: cerebral aneurysm; intracranial aneurysm; packing density; Target Coils; aneurysm embolization
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Arterial Diseases; Aneurysm; Intracranial Aneurysm
• Other Study ID Numbers: 19180