TARGET Intracranial Aneurysm Coiling Registry (TARGET)
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|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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01748903
|Contact: Victoria J Calderon, MPHfirstname.lastname@example.org|
|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 email@example.com|
|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|