AneurysmsRACERNCT00703794
Researching AXIUM Coiling Experience and Recanalization (RACER)
An observational study of Aneurysms and Vascular Diseases, run by Medtronic Neurovascular Clinical Affairs at 18 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aneurysms, Vascular Diseases, Cerebrovascular Disorders
- What is being tested?
- The AXIUM Progressive Coil System
- Type of treatment
- Medical device
- How many people
- 119 participants
- Where
- 18 sitesUnited States
- Study dates
- Jun 2008to 16 Jan 2012
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with intracranial aneurysm, either ruptured or un-ruptured, with aneurysm has a maximum diameter of 2mm to 20mm
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Kaleida Health - Millard Fillmore
Buffalo, New York, 14209
Fletcher Allen Health Care
Burlington, Vermont, 05401-1473
Medical University of South Carolina (MUSC)
Charleston, South Carolina, 29425
Neurologic & Orthopedic Hospital of Chicago (NOHC)
Chicago, Illinois, 60640
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Palmetto Richland Health Memorial Hospital
Columbia, South Carolina, 29203
Lee Memorial Health System
Fort Myers, Florida, 33908
Lac+Usc/Uscuh
Los Angeles, California, 90089
University of Wisconsin
Madison, Wisconsin, 53792
University of Miami - Jackson Memorial Hospital Systems
Miami, Florida, 33136
Abbott Northwestern
Minneapolis, Minnesota, 55407
Vascular and Interventional Specialists of Orange County, Inc. - St. Joseph Hospital of Orange
Orange, California, 92868
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Oregon Health & Science University (OHSU)
Portland, Oregon, 97239
Bayfront Medical Center
St. Petersburg, Florida, 33701
Tampa General Hospital
Tampa, Florida, 33606
University of Massachusetts Medical Center
Worcester, Massachusetts, 01655
About this study
Official title: ev3 Researching AXIUM Coiling Experience and Recanalization (RACER)
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.
- Being tested
- The AXIUM Progressive Coil System
- 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
- Medical subject headings
- Aneurysm, Vascular Diseases, Cerebrovascular Disorders, Intracranial Arterial Diseases, Brain Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The AXIUM Progressive Coil SystemDevice
Embolization of aneurysm
| Study group | Role | What they receive |
|---|---|---|
| AXIUM Coils | Not described Receives: Device: The AXIUM Progressive Coil System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Occlusion
Measured: Defined in protocol
Secondary outcomes (1)
Morbidity/Mortality
Measured: Defined in protocol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2008 (estimated)
- Study startJun 2008
- Primary completion16 Jan 2012
- Study completion16 Jan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for AneurysmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 119 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Medtronic Neurovascular Clinical Affairs
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ajay K Wakhloo, MD, PhD, Principal investigator, University of Massachusetts, Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00703794
- Sponsor's protocol ID
- ev3-FD1942-CR00045
- Acronym
- RACER
- Status last verified
- Oct 2018
- First submitted
- 23 Jun 2008
- Last updated
- 29 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 8315465Wakhloo 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.
PubMed 17698550Linfante 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.
PubMed 17322071Razack 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.
PubMed 15206430Mericle 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.
PubMed 16575325Thornton 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.
PubMed 11844258
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ev3 Researching AXIUM Coiling Experience and Recanalization (RACER)
- ClinicalTrials.gov ID
- NCT00703794
- Acronym / sponsor ID
- RACER / ev3-FD1942-CR00045
- Keywords
- ev3 Neurovascular, aneurysms, cerebrovascular, endovascular, neurovascular therapies, RACER, AXIUM, The AXIUM Progressive Coil System
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Medtronic Neurovascular Clinical AffairsIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- 16 Jan 2012 (actual)
- Study completion
- 16 Jan 2012 (actual)
- First posted
- 24 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AXIUM Coils | – | Device: The AXIUM Progressive Coil System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with intracranial aneurysm, either ruptured or un-ruptured, with aneurysm has a maximum diameter of 2mm to 20mm
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The AXIUM Progressive Coil SystemEmbolization of aneurysm | Device | AXIUM Coils |
Primary outcome
Percent Occlusion
Time frame: Defined in protocol
1 secondary outcome
Morbidity/Mortality
Time frame: Defined in protocol
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2018.
- Background: PubMed 8315465Casasco 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.
- Background: PubMed 17698550Wakhloo 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.
- Background: PubMed 17322071Linfante 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.
- Background: PubMed 15206430Razack 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.
- Background: PubMed 16575325Mericle 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.
- Background: PubMed 11844258Thornton 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.
- ev3 Inc.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ajay K Wakhloo, MD, PhD principal investigator
University of Massachusetts, Worcester
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aneurysms and Vascular Diseases, run by Medtronic Neurovascular Clinical Affairs at 18 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Occlusion (time frame: Defined in protocol). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00703794, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2018.