TARGET Intracranial Aneurysm Coiling Registry

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Medical College of Wisconsin
Sponsor:
Collaborator:
Stryker Neurovascular
Information provided by (Responsible Party):
Osama Zaidat, MD, MSc, Medical College of Wisconsin
ClinicalTrials.gov Identifier:
NCT01748903
First received: December 7, 2012
Last updated: November 26, 2013
Last verified: November 2013
  Purpose

The purpose of this prospective registry is to collect real world, post-marketing data on the use of Stryker Target® 360° and Target® 2D coils for the embolization of ruptured or unruptured intracranial saccular aneurysms. Up to 150 patients presenting with intracranial aneurysms suitable for coil embolization will be enrolled at approximately 10 sites. A post hoc analysis comparing Target® 360° and Target® 2D coil technical and clinical endpoints will be performed.


Condition Intervention Phase
Intracranial Aneurysms
Device: Embolization using Target 360° and Target 2D Coils
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: TARGET Intracranial Aneurysm Coiling Registry: A Prospective Clinical Efficacy and Safety Study of Stryker Target® 360° and Target® 2D Coils

Resource links provided by NLM:


Further study details as provided by Medical College of Wisconsin:

Primary Outcome Measures:
  • Packing Density [ Time Frame: At immediate post-procedure (Day 1) ] [ Designated as safety issue: No ]
    Packing density will be calculated based on aneurysm volume and amount of coil used during the embolization procedure.


Secondary Outcome Measures:
  • Occlusion Rate [ Time Frame: At immediate post-procedure (Day 1) and 3-9 month follow-up ] [ Designated as safety issue: No ]
    Angiographic occlusion of the aneurysm will be adjudicated by an independent core lab using immediate post-procedure and 3-9 month follow-up angiography.

  • Aneurysm Re-access Rate [ Time Frame: At end of study procedure (Day 1) ] [ Designated as safety issue: No ]
    The rate of re-assess (Microcatheter kick-back rate) of the target aneurysm will be captured during the procedure.

  • Time of Fluoroscopic Exposure [ Time Frame: At immediate post-procedure (Day 1) ] [ Designated as safety issue: Yes ]
    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.

  • Overall Procedure Time [ Time Frame: At Immediate post-procedure (Day 1) ] [ Designated as safety issue: No ]
    The overall procedure time will be captured from the time of guide catheter placement to the end of the coil embolization procedure.

  • Aneurysm Recurrence [ Time Frame: 3-9 month follow-up ] [ Designated as safety issue: No ]
  • Aneurysm Re-treatment Rate [ Time Frame: 3-9 month follow-up ] [ Designated as safety issue: No ]
    Aneurysm re-treatment rates will be tracked and recorded during the 3-9 month follow-up

  • Aneurysm Bleed and Re-bleed Rate [ Time Frame: 3-9 month follow-up ] [ Designated as safety issue: Yes ]
    Aneurysm Bleed and Re-bleed Rate will be assessed and recorded at the 3-9 month follow-up.

  • Treatment-related Morbidity and Mortality [ Time Frame: from study procedure (Day 1) to 3-9 month follow-up ] [ Designated as safety issue: Yes ]
    Treatment-related morbidity and morality will be tracked and recorded from study procedure through the 3-9 month follow-up.

  • Modified Rankin Score [ Time Frame: At baseline (Day 1) and hospital discharge (Day 3) and 3-9 month follow-up ] [ Designated as safety issue: No ]
    Modified Rankin score will be recorded at baseline, hospital discharge, and during the 3-9 month follow-up.

  • Device-related serious adverse events [ Time Frame: From the study procedure (Day 1) until 3-9 month follow up ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: At hospital discharge (Day 3) ] [ Designated as safety issue: No ]
    Length of hospital stay will be recorded at the time of patient discharge.

  • Technical and clinical endpoints of Target 360° and 2D coils [ Time Frame: 3-9 month follow-up ] [ Designated as safety issue: No ]
    A post hoc analysis comparing Target 360° and 2D coil primary and secondary technical and clinical endpoints will be performed upon final data analysis.


Estimated Enrollment: 150
Study Start Date: February 2013
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Embolization using Target 360° and Target 2D Coils

Subjects will receive Target 360° and/or Target 2D Coils for the treatment of their intracranial aneurysm. All attempts should be made by the operator to coil the target aneurysm as follows:

  • Target aneurysm ≤ 4mm: ≥ 50% total length of Target® 360° or Target® 2D coils
  • Target aneurysm > 4mm: ≥ 70% total length of Target® 360° or Target® 2D coils
Device: Embolization using Target 360° and Target 2D Coils
Other Names:
  • Target coils
  • Target Nano coil

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient is 18 years or older.
  2. Patient has a documented, saccular intracranial aneurysm, unruptured or ruptured, suitable for embolization with coils.
  3. Patient has a Hunt and Hess Score of 3 or less.
  4. Patient or patient's legally authorized representative has provided written informed consent.
  5. 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 in whom the target aneurysm will be treated with coils other than Stryker Target® 360° and Target® 2D coils.
  4. Target aneurysm is fusiform.
  5. Patients in which the target aneurysm cannot be coiled in one procedure (i.e. staged procedure)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01748903

Contacts
Contact: Alicia C Castonguay, PhD 4148055439 acastonguay@mcw.edu

Locations
United States, California
University of Southern California Recruiting
Los Angeles, California, United States, 90033
Principal Investigator: William J Mack, MD         
Desert Regional Medical Center Recruiting
Palm Springs, California, United States, 92264
Contact: M. Asif Taqi, MD         
Principal Investigator: M. Asif Taqi, MD         
United States, Connecticut
Yale New Haven Hospital Recruiting
New Haven, Connecticut, United States, 06510
Principal Investigator: Ketan R Bulsara, MD         
United States, Illinois
Presence Saint Joseph Medical Center Recruiting
Joliet, Illinois, United States, 60435
Principal Investigator: Aamir Badruddin, MD         
United States, Massachusetts
University of Massachusetts Medical School Recruiting
Worcester, Massachusetts, United States, 01655
Principal Investigator: Ajit Puri, MD         
United States, Michigan
Michigan State University Recruiting
East lansing, Michigan, United States, 48824
Principal Investigator: Syed I Hussain, MD         
United States, Missouri
SSM DePaul Health Center Recruiting
St. Louis, Missouri, United States, 63132
Principal Investigator: Amer Alshekhlee, MD         
Sub-Investigator: Richard Callison, MD         
United States, Pennsylvania
Abington Memorial Hospital Recruiting
Abington, Pennsylvania, United States, 19001
Contact: Qaisar Shah         
Principal Investigator: Qaisar Shah, MD         
United States, Texas
Texas Stroke Institute Recruiting
Plano, Texas, United States, 75075
Principal Investigator: Vallabh Janardhan, MD         
United States, West Virginia
West Virginia University Hospital Recruiting
Morgantown, West Virginia, United States, 26505
Principal Investigator: Ansaar Rai, MD         
United States, Wisconsin
Gundersen Lutheran Recruiting
La Crosse, Wisconsin, United States, 54601
Principal Investigator: Mouhammad R Kabbani, MD         
Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Alicia C Castonguay, PhD    414-805-5439    acastonguay@mcw.edu   
Principal Investigator: Osama O Zaidat, MD, MS         
Sponsors and Collaborators
Osama Zaidat, MD, MSc
Stryker Neurovascular
Investigators
Principal Investigator: Osama O Zaidat, MD, MS Medical College of Wisconsin
  More Information

No publications provided

Responsible Party: Osama Zaidat, MD, MSc, Professor of Neurology, Neurosurgery, & Radiology, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT01748903     History of Changes
Other Study ID Numbers: 19180
Study First Received: December 7, 2012
Last Updated: November 26, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Medical College of Wisconsin:
intracranial aneurysm
cerebral aneurysm
packing density
Target Coils
aneurysm embolization

Additional relevant MeSH terms:
Aneurysm
Intracranial Aneurysm
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on August 20, 2014