Researching AXIUM Coiling Experience and Recanalization (RACER)
RACER
ev3 Researching AXIUM Coiling Experience and Recanalization (RACER)
1 other identifier
observational
119
1 country
18
Brief Summary
The data collected in this study will be used to support International Regulatory submissions. The study objective is to evaluate the continued safety and efficacy of the AXIUM Progressive Coil System. This Device has been used clinically at approximately 150 Institutions under FDA 510(k) clearance since April 24, 2007. The device received CE authorization on June 30, 2007. Through December 2007, more than 1000 patients have been treated with the AXIUM Coils.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2008
Typical duration for all trials
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 23, 2008
CompletedFirst Posted
Study publicly available on registry
June 24, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 16, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 16, 2012
CompletedOctober 29, 2018
October 1, 2018
3.6 years
June 23, 2008
October 26, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percent Occlusion
Defined in protocol
Secondary Outcomes (1)
Morbidity/Mortality
Defined in protocol
Study Arms (1)
AXIUM Coils
Interventions
Eligibility Criteria
Patients with intracranial aneurysm, either ruptured or un-ruptured, with aneurysm has a maximum diameter of 2mm to 20mm
You may qualify if:
- Patient or patient's legally authorized representative has signed and dated an Informed Consent Form
- Must be at least 18 years of age
- Aneurysm location, angio-architecture, morphology, or medical condition, is considered by the neurosurgical / interventional team to be at very high risk for management by traditional operative techniques, or aneurysm is considered to be inoperable
- Patient is willing to conduct follow-up visits
You may not qualify if:
- Aneurysm was previously treated
- Patient has a cerebral aneurysm with a location, angioarchitecture or morphology that presents an unacceptable risk of morbidity due to the Study procedures
- Patient is participating in another clinical research Study
- Patient has a medical, social or psychological condition, which precludes the patient from receiving Study required treatment, evaluation, procedures and follow-up
- Female patient is pregnant or breast-feeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
Lac+Usc/Uscuh
Los Angeles, California, 90089, United States
Vascular and Interventional Specialists of Orange County, Inc. - St. Joseph Hospital of Orange
Orange, California, 92868, United States
Lee Memorial Health System
Fort Myers, Florida, 33908, United States
University of Miami - Jackson Memorial Hospital Systems
Miami, Florida, 33136, United States
Bayfront Medical Center
St. Petersburg, Florida, 33701, United States
Tampa General Hospital
Tampa, Florida, 33606, United States
Neurologic & Orthopedic Hospital of Chicago (NOHC)
Chicago, Illinois, 60640, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
University of Massachusetts Medical Center
Worcester, Massachusetts, 01655, United States
Abbott Northwestern
Minneapolis, Minnesota, 55407, United States
Kaleida Health - Millard Fillmore
Buffalo, New York, 14209, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Oregon Health & Science University (OHSU)
Portland, Oregon, 97239, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
Medical University of South Carolina (MUSC)
Charleston, South Carolina, 29425, United States
Palmetto Richland Health Memorial Hospital
Columbia, South Carolina, 29203, United States
Fletcher Allen Health Care
Burlington, Vermont, 05401-1473, United States
University of Wisconsin
Madison, Wisconsin, 53792, United States
Related Publications (6)
Casasco AE, Aymard A, Gobin YP, Houdart E, Rogopoulos A, George B, Hodes JE, Cophignon J, Merland JJ. Selective endovascular treatment of 71 intracranial aneurysms with platinum coils. J Neurosurg. 1993 Jul;79(1):3-10. doi: 10.3171/jns.1993.79.1.0003.
PMID: 8315465BACKGROUNDWakhloo AK, Gounis MJ, Sandhu JS, Akkawi N, Schenck AE, Linfante I. Complex-shaped platinum coils for brain aneurysms: higher packing density, improved biomechanical stability, and midterm angiographic outcome. AJNR Am J Neuroradiol. 2007 Aug;28(7):1395-400. doi: 10.3174/ajnr.A0542.
PMID: 17698550BACKGROUNDLinfante I, Wakhloo AK. Brain aneurysms and arteriovenous malformations: advancements and emerging treatments in endovascular embolization. Stroke. 2007 Apr;38(4):1411-7. doi: 10.1161/01.STR.0000259824.10732.bb. Epub 2007 Feb 22.
PMID: 17322071BACKGROUNDRazack N, Thompson BG. Treatment of intracranial aneurysms: clipping or coiling? J Neuroophthalmol. 2004 Mar;24(1):1-2. doi: 10.1097/00041327-200403000-00001. No abstract available.
PMID: 15206430BACKGROUNDMericle RA, Reig AS, Burry MV, Eskioglu E, Firment CS, Santra S. Endovascular surgery for proximal posterior inferior cerebellar artery aneurysms: an analysis of Glasgow Outcome Score by Hunt-Hess grades. Neurosurgery. 2006 Apr;58(4):619-25; discussion 619-25. doi: 10.1227/01.NEU.0000204127.81249.28.
PMID: 16575325BACKGROUNDThornton J, Debrun GM, Aletich VA, Bashir Q, Charbel FT, Ausman J. Follow-up angiography of intracranial aneurysms treated with endovascular placement of Guglielmi detachable coils. Neurosurgery. 2002 Feb;50(2):239-49; discussion 249-50. doi: 10.1097/00006123-200202000-00003.
PMID: 11844258BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ajay K Wakhloo, MD, PhD
University of Massachusetts, Worcester
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Target Duration
- 6 Months
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 23, 2008
First Posted
June 24, 2008
Study Start
June 1, 2008
Primary Completion
January 16, 2012
Study Completion
January 16, 2012
Last Updated
October 29, 2018
Record last verified: 2018-10