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 : December 14, 2016
|Condition or disease||Intervention/treatment||Phase|
|Intracranial Aneurysms||Device: Target 360°, 2D Coils, Nano Coils||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 2018|
|Estimated Study Completion Date :||April 2018|
Experimental: 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
- 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.
- 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.
- 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.
- 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.
- 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.
- Aneurysm Recurrence [ Time Frame: 3-9 month follow-up ]
- 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
- 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.
- 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.
- 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.
- 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.
- Length of hospital stay [ Time Frame: At hospital discharge (Day 3) ]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 ]A post hoc analysis comparing Target 360° and 2D coil primary and secondary technical and clinical endpoints will be performed upon final data analysis.
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
|Contact: Victoria J Calderon, MPHemail@example.com|
|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, Missouri|
|SSM DePaul Health Center||Recruiting|
|St. 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 firstname.lastname@example.org|
|Principal Investigator: Osama O Zaidat, MD, MS|
|United States, Pennsylvania|
|Abington Memorial Hospital||Recruiting|
|Abington, Pennsylvania, United States, 19001|
|Contact: Qaisar Shah|
|Principal Investigator: Qaisar Shah, MD|
|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|
|Principal Investigator:||Osama O Zaidat, MD, MS||Mercy Health St. Vincent Medical Center|