Researching AXIUM Coiling Experience and Recanalization (RACER)

Vascular Diseases Clinical Trial

— RACER  

Official title:

ev3 Researching AXIUM Coiling Experience and Recanalization (RACER)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00703794
• Other study ID #: ev3-FD1942-CR00045
• Status: Completed
• Start date: June 2008
• Est. completion date: January 16, 2012

Study information

• Verified date: October 2018
• Source: Medtronic Neurovascular Clinical Affairs
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: January 16, 2012
• Est. primary completion date: January 16, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Aneurysms
• Cerebrovascular Disorders
• Intracranial Arterial Diseases
• Vascular Diseases

Intervention

Device:
• The AXIUM Progressive Coil System
Embolization of aneurysm

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Kaleida Health - Millard Fillmore	Buffalo	New York
United States	Fletcher Allen Health Care	Burlington	Vermont
United States	Medical University of South Carolina (MUSC)	Charleston	South Carolina
United States	Neurologic & Orthopedic Hospital of Chicago (NOHC)	Chicago	Illinois
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Palmetto Richland Health Memorial Hospital	Columbia	South Carolina
United States	Lee Memorial Health System	Fort Myers	Florida
United States	Lac+Usc/Uscuh	Los Angeles	California
United States	University of Wisconsin	Madison	Wisconsin
United States	University of Miami - Jackson Memorial Hospital Systems	Miami	Florida
United States	Abbott Northwestern	Minneapolis	Minnesota
United States	Vascular and Interventional Specialists of Orange County, Inc. - St. Joseph Hospital of Orange	Orange	California
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Oregon Health & Science University (OHSU)	Portland	Oregon
United States	Bayfront Medical Center	Saint Petersburg	Florida
United States	Tampa General Hospital	Tampa	Florida
United States	University of Massachusetts Medical Center	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Neurovascular Clinical Affairs

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Linfante I, Wakhloo AK. Brain aneurysms and arteriovenous malformations: advancements and emerging treatments in endovascular embolization. Stroke. 2007 Apr;38(4):1411-7. Epub 2007 Feb 22. Review. — View 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. — View Citation

Razack N, Thompson BG. Treatment of intracranial aneurysms: clipping or coiling? J Neuroophthalmol. 2004 Mar;24(1):1-2. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Occlusion		Defined in protocol
Secondary	Morbidity/Mortality		Defined in protocol

External Links

•   Cerebral Aneurysm Information Page
•   ev3 Inc.