Efficacy Trial of Intracranial Aneurysm Treatment Using Two Different Endovascular Techniques

Not Applicable

• Conditions: Intracranial Aneurysms
• Interventions: Device: Endovascular treatment of intracranial aneurysms; Device: Endovascular treatment of intracranial aneurysm with coils

• Registration Number: NCT01084681
• Lead Sponsor: Balt International

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.

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-03-08
• Study First Submitted QC: 2010-03-09
• Study First Posted: 2010-03-10
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-07
• Last Update Posted: 2011-06-08
• Primary Completion: 2012-10
• Study Completion: 2012-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 160

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SILK Artery Reconstruction Device	Endovascular treatment of intracranial aneurysms	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).
Coils	Endovascular treatment of intracranial aneurysm with 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.

Primary Outcome Measures

Name	Time	Method
Efficacy	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.

Secondary Outcome Measures

Name	Time	Method
Safety	12 months	Safety will be evaluated as follows: 1. Peri-procedural ischemic and hemorrhagic adverse events; 2. Peri-procedural technical complications; 3. Death from any cause; 4. Neurological deterioration; 5. Cranial nerve deficit; 6. General adverse events; In addition, Subject Quality of Life (QOL) will be measured at baseline and at 12 months post-procedure using the EuroQol questionnaire.

Trial Locations

Locations (1)

Universitätsklinikum Würzburg; Abteilung für Neuroradiologie; 🇩🇪 Wuerzburg, Germany