Clinical trial NCT00703794: Researching AXIUM Coiling Experience and Recanalization (RACER)
Official title: ev3 Researching AXIUM Coiling Experience and Recanalization (RACER)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aneurysms
Vascular Diseases
Cerebrovascular Disorders
Intracranial Arterial Diseases
Keywords: ev3 Neurovascular
aneurysms
cerebrovascular
endovascular
neurovascular therapies
RACER
AXIUM
The AXIUM Progressive Coil System
ev3
MTI
Micro Therapeutics
FX detachable coil system
K060747
brain diseases
Lead sponsor: Medtronic Neurovascular Clinical Affairs
Sponsor class: INDUSTRY
First posted: 2008-06-24
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with intracranial aneurysm, either ruptured or un-ruptured, with aneurysm has a maximum diameter of 2mm to 20mm

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Percent Occlusion
timeFrame: Defined in protocol
Secondary outcomes:
measure: Morbidity/Mortality
timeFrame: Defined in protocol
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Lac+Usc/Uscuh
state: California
city: Orange
country: United States
facility: Vascular and Interventional Specialists of Orange County, Inc. - St. Joseph Hospital of Orange
state: California
city: Fort Myers
country: United States
facility: Lee Memorial Health System
state: Florida
city: Miami
country: United States
facility: University of Miami - Jackson Memorial Hospital Systems
state: Florida
city: Saint Petersburg
country: United States
facility: Bayfront Medical Center
state: Florida
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Chicago
country: United States
facility: Neurologic & Orthopedic Hospital of Chicago (NOHC)
state: Illinois
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Worcester
country: United States
facility: University of Massachusetts Medical Center
state: Massachusetts
city: Minneapolis
country: United States
facility: Abbott Northwestern
state: Minnesota
city: Buffalo
country: United States
facility: Kaleida Health - Millard Fillmore
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Portland
country: United States
facility: Oregon Health & Science University (OHSU)
state: Oregon
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina (MUSC)
state: South Carolina
city: Columbia
country: United States
facility: Palmetto Richland Health Memorial Hospital
state: South Carolina
city: Burlington
country: United States
facility: Fletcher Allen Health Care
state: Vermont
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Massachusetts, Worcester
name: Ajay K Wakhloo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Wakhloo 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.
citation: Linfante 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.
citation: Razack 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.
citation: Mericle 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.
citation: Thornton 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.