Clinical trial NCT01084681: Efficacy Trial of Intracranial Aneurysm Treatment Using Two Different Endovascular Techniques
Official title: 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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intracranial Aneurysms
Keywords: SILK flow diverter, intracranial stents, intracranial aneurysms
Lead sponsor: Balt International
Sponsor class: INDUSTRY
First posted: 2010-03-10
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Efficacy
timeFrame: 12 months
Secondary outcomes:
measure: Safety
timeFrame: 12 months
Other outcomes:
Locations:
city: Wuerzburg
country: Germany
facility: Universitätsklinikum Würzburg; Abteilung für Neuroradiologie
Study officials:
affiliation: Beaujon Hospital - Paris Diderot University (Paris, France)
name: Jacques Moret, MD
role: STUDY_CHAIR
References: