Efficacy Trial of Intracranial Aneurysm Treatment Using Two Different Endovascular Techniques
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)
1 other identifier
interventional
160
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2010
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2010
CompletedFirst Submitted
Initial submission to the registry
March 8, 2010
CompletedFirst Posted
Study publicly available on registry
March 10, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedJune 8, 2011
June 1, 2011
2.6 years
March 8, 2010
June 7, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Efficacy
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 Outcomes (1)
Safety
12 months
Study Arms (2)
SILK Artery Reconstruction Device
ACTIVE COMPARATOROne 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).
Coils
ACTIVE COMPARATORThe other arm will be treated with commercially available intracranial coils: the coils can be used with eventual balloon remodeling and/or stents when necessary.
Interventions
Endovascular treatment with the SILK Artery Reconstruction Device for occluding intracranial aneurysms.
Endovascular treatment with commercially available intracranial coils for occluding intracranial aneurysms.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Universitätsklinikum Würzburg; Abteilung für Neuroradiologie
Würzburg, 97080, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jacques Moret, MD
Beaujon Hospital - Paris Diderot University (Paris, France)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 8, 2010
First Posted
March 10, 2010
Study Start
March 1, 2010
Primary Completion
October 1, 2012
Study Completion
October 1, 2012
Last Updated
June 8, 2011
Record last verified: 2011-06