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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00703794
Other study ID # ev3-FD1942-CR00045
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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