ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT01748903
Previous Study | Return to List | Next Study

TARGET Intracranial Aneurysm Coiling Registry (TARGET)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01748903
Recruitment Status : Recruiting
First Posted : December 13, 2012
Last Update Posted : July 24, 2018
Sponsor:
Collaborator:
Stryker Neurovascular
Information provided by (Responsible Party):
Dr. Osama O. Zaidat, 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.

Condition or disease Intervention/treatment
Intracranial Aneurysms Device: Target 360°, 2D Coils, Nano Coils

Study Type : Observational [Patient Registry]
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
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
Study Start Date : February 2013
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Packing Density [ Time Frame: 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 :
  1. Occlusion Rate [ Time Frame: 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.

  2. Aneurysm Re-access Rate [ Time Frame: 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.

  3. Time of Fluoroscopic Exposure [ Time Frame: 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.

  4. Overall Procedure Time [ Time Frame: 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.

  5. Aneurysm Recurrence [ Time Frame: 3-9 month follow-up ]
  6. Aneurysm Re-treatment Rate [ Time Frame: 3-9 month follow-up ]
    Aneurysm re-treatment rates will be tracked and recorded during the 3-9 month follow-up

  7. Aneurysm Bleed and Re-bleed Rate [ Time Frame: 3-9 month follow-up ]
    Aneurysm Bleed and Re-bleed Rate will be assessed and recorded at the 3-9 month follow-up.

  8. Treatment-related Morbidity and Mortality [ Time Frame: 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.

  9. Modified Rankin Score [ Time Frame: 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.

  10. Device-related serious adverse events [ Time Frame: 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.

  11. Length of hospital stay [ Time Frame: At hospital discharge (Day 3) ]
    Length of hospital stay will be recorded at the time of patient discharge.

  12. Technical and clinical endpoints of Target 360° and 2D coils [ Time Frame: 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.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01748903


Contacts
Contact: Victoria J Calderon, MPH 4192514367 vcalderon@mercy.com

Locations
United States, Arizona
University of Arizona Recruiting
Phoenix, Arizona, United States, 85006
Principal Investigator: Peter J Sunenshine, MD         
United States, Florida
Tallahassee Neurological Clinic Recruiting
Tallahassee, Florida, United States, 32308
Principal Investigator: Matthew Lawson, MD         
Sub-Investigator: Narlin Beaty, MD         
Principal Investigator: T. Adam Oliver, 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
McLaren Health Recruiting
Flint, Michigan, United States, 48532
Principal Investigator: Aniel Q Majjhoo, MD         
Sub-Investigator: Bharath R Naravetla, MD         
United States, Missouri
SSM DePaul Health Center Recruiting
Saint Louis, Missouri, United States, 63132
Principal Investigator: Amer Alshekhlee, MD         
Sub-Investigator: Richard Callison, MD         
United States, Ohio
Mercy Health St. Vincent Medical Center Recruiting
Toledo, Ohio, United States, 43604
Contact: Victoria J Calderon, MPH    419-251-4367    vcalderon@mercy.com   
Principal Investigator: Osama O Zaidat, MD, MS         
United States, South Carolina
Greenville Health System Recruiting
Greenville, South Carolina, United States, 29605
Principal Investigator: Mahmoud Rayes, MD         
United States, West Virginia
West Virginia University Hospital Recruiting
Morgantown, West Virginia, United States, 26505
Principal Investigator: Ansaar Rai, MD         
Sponsors and Collaborators
Mercy Health Ohio
Stryker Neurovascular
Investigators
Principal Investigator: Osama O Zaidat, MD, MS Mercy Health St. Vincent Medical Center

Responsible Party: Dr. Osama O. Zaidat, Medical Director, Neuroscience and Stroke Programs, Mercy Health Ohio
ClinicalTrials.gov Identifier: NCT01748903     History of Changes
Other Study ID Numbers: 19180
First Posted: December 13, 2012    Key Record Dates
Last Update Posted: July 24, 2018
Last Verified: July 2018

Keywords provided by Dr. Osama O. Zaidat, Mercy Health Ohio:
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