- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01084681
Efficacy Trial of Intracranial Aneurysm Treatment Using Two Different Endovascular Techniques
June 7, 2011 updated by: Balt International
Multicenter Randomized Trial on Selective Endovascular Aneurysm Occlusion With Coils Versus Parent Vessel Reconstruction Using the SILK Flow Diverter (MARCO POLO Post-Market Clinical Investigation)
To date the standard non-surgical treatment strategy for treating un-ruptured intracranial aneurysms is the use of either coils or self-expandable stents.
This post-market clinical investigation compares the efficacy of using the CE-marked, commercially available SILK Artery Reconstruction Device against commercially available intracranial coils in the endovascular treatment (occlusion) of intracranial aneurysms.
Study Overview
Status
Unknown
Conditions
Detailed Description
To date the standard non-surgical treatment strategy for treating un-ruptured intracranial aneurysms is the use of either coils or self-expandable stents.
The flow diverter stent concept is based upon the hemodynamic exclusion of the aneurysm sac, without coils being eventually placed within the sac.
The primary objective of this post-market clinical investigation is to demonstrate that when using the CE-marked, commercially available SILK Artery Reconstruction Device in the indication for which it is approved, notably for the treatment (occlusion) of intracranial aneurysms, the anatomical results are superior compared to standard treatment with commercially available intracranial coils (used with eventual balloon remodeling and/or stents when necessary).
It is a prospective, randomized, unblinded, multi-center post-market clinical investigation.
The patient population comprises a maximum of 160 subjects with at least one documented untreated, unruptured intracranial aneurysm suitable for occlusion with an intracranial device.
Subject enrollment will require a maximum of 18 months.
Enrolled subjects will be followed for 12 months after treatment.
Study Type
Interventional
Enrollment (Anticipated)
160
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Linda Nicolini, MBA
- Phone Number: +33 1 39894641
- Email: linda.nicolini@balt.fr
Study Contact Backup
- Name: Alan Cohen, BS
- Phone Number: +32 473 865091
- Email: alanscohen@skynet.be
Study Locations
-
-
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Wuerzburg, Germany, 97080
- Recruiting
- Universitätsklinikum Würzburg; Abteilung für Neuroradiologie
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Contact:
- Linda Nicolini, MBA
- Phone Number: +33 1 39894641
- Email: linda.nicolini@balt.fr
-
Contact:
- Alan Cohen, BS
- Phone Number: +32 473 865091
- Email: alanscohen@skynet.be
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Principal Investigator:
- László Solymosi, MD
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- At least one documented untreated, unruptured intracranial aneurysm
- The intracranial aneurysm is non-thrombosed and non-hemorrhagic
- Saccular Carotid Siphon: with a sac diameter of ≥7mm to ≤15mm
- Lateral vertebral aneurysms of V4, and side-wall basilar trunk aneurysms
- Target aneurysm morphology permits the use of intracranial devices, as determined by the treating physician
- Subject greater than or equal to 18 years old
- Life expectancy greater than or equal to 12 months
- Subject (or subject's legally authorized representative) has provided written informed consent
- Subject is willing and able to comply with protocol follow-up requirements
Exclusion Criteria:
- Subject is under guardianship
- Significant atherosclerotic disease, stenosis, tortuosity or other condition preventing microcatheter access to the target aneurysm(s)
- Vessel branch arising from the aneurysm sac
- Fusiform aneurysm
- Ruptured aneurysm
- Bifurcation aneurysms (MCA, ACoA)
- Recurrent aneurysm
- Presence of an intracranial stent on the side that is to be treated
- High risk surgical subjects with significant pre-existing co-morbid condition(s), not treated or well controlled with standard therapy
- Bleeding disorder which would preclude percutaneous intervention and/or anti-thrombotic therapy; resistance to anti-platelet treatment
- Intracranial intervention performed within 30 days prior to the procedure or elective intracranial intervention planned within 12 months following the procedure
- Major surgical procedure (e.g., coronary artery bypass graft, valve replacement, abdominal aortic aneurysm repair, bowel resection) performed within 30 days preceding or planned within 12 months following the procedure.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: SILK Artery Reconstruction Device
One arm will receive only the commercially available SILK Artery Reconstruction Device [flow diverter] (no intracranial coils are to be used in association with the SILK device).
|
Endovascular treatment with the SILK Artery Reconstruction Device for occluding intracranial aneurysms.
|
Active Comparator: Coils
The other arm will be treated with commercially available intracranial coils: the coils can be used with eventual balloon remodeling and/or stents when necessary.
|
Endovascular treatment with commercially available intracranial coils for occluding intracranial aneurysms.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Efficacy
Time Frame: 12 months
|
The primary objective is to demonstrate that when using the SILK Artery Reconstruction Device in the indication for which it is approved, notably for the treatment (occlusion) of intracranial aneurysms, the anatomical results are superior compared to standard treatment with commercially available intracranial coils.
Therefore, angiographic assessment will measure efficacy by determining the percentage of subjects in each of the two arms experiencing complete occlusion of the aneurysm at 12 months post-procedure.
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety
Time Frame: 12 months
|
Safety will be evaluated as follows:
In addition, Subject Quality of Life (QOL) will be measured at baseline and at 12 months post-procedure using the EuroQol questionnaire. |
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Jacques Moret, MD, Beaujon Hospital - Paris Diderot University (Paris, France)
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2010
Primary Completion (Anticipated)
October 1, 2012
Study Completion (Anticipated)
October 1, 2012
Study Registration Dates
First Submitted
March 8, 2010
First Submitted That Met QC Criteria
March 9, 2010
First Posted (Estimate)
March 10, 2010
Study Record Updates
Last Update Posted (Estimate)
June 8, 2011
Last Update Submitted That Met QC Criteria
June 7, 2011
Last Verified
June 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Balt 2010-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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