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Researching AXIUM Coiling Experience and Recanalization (RACER) (RACER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00703794
Recruitment Status : Completed
First Posted : June 24, 2008
Last Update Posted : October 29, 2018
Sponsor:
Information provided by (Responsible Party):
Medtronic Neurovascular Clinical Affairs

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.


Condition or disease Intervention/treatment
Aneurysms Vascular Diseases Cerebrovascular Disorders Intracranial Arterial Diseases Device: The AXIUM Progressive Coil System

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Study Type : Observational [Patient Registry]
Actual Enrollment : 119 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: ev3 Researching AXIUM Coiling Experience and Recanalization (RACER)
Study Start Date : June 2008
Actual Primary Completion Date : January 16, 2012
Actual Study Completion Date : January 16, 2012

Group/Cohort Intervention/treatment
AXIUM Coils Device: The AXIUM Progressive Coil System
Embolization of aneurysm




Primary Outcome Measures :
  1. Percent Occlusion [ Time Frame: Defined in protocol ]

Secondary Outcome Measures :
  1. Morbidity/Mortality [ Time Frame: Defined in protocol ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00703794


Locations
Show Show 18 study locations
Sponsors and Collaborators
Medtronic Neurovascular Clinical Affairs
Investigators
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Principal Investigator: Ajay K Wakhloo, MD, PhD University of Massachusetts, Worcester
Additional Information:
Publications:
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Responsible Party: Medtronic Neurovascular Clinical Affairs
ClinicalTrials.gov Identifier: NCT00703794    
Other Study ID Numbers: ev3-FD1942-CR00045
First Posted: June 24, 2008    Key Record Dates
Last Update Posted: October 29, 2018
Last Verified: October 2018
Keywords provided by Medtronic Neurovascular Clinical Affairs:
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
Additional relevant MeSH terms:
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Cerebrovascular Disorders
Intracranial Arterial Diseases
Aneurysm
Vascular Diseases
Cardiovascular Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases