Efficacy Trial of Intracranial Aneurysm Treatment Using Two Different Endovascular Techniques

Balt

Status: Unknown

Conditions: Intracranial Aneurysms

Treatments: Device: Endovascular treatment of intracranial aneurysm with coils; Device: Endovascular treatment of intracranial aneurysms

Study type: Interventional

Funder types: Industry

Identifiers

NCT01084681

Balt 2010-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 160 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

SILK Artery Reconstruction Device

Active Comparator group

Description:

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).

Treatment:

Device: Endovascular treatment of intracranial aneurysms

Coils

Active Comparator group

Description:

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.

Treatment:

Device: Endovascular treatment of intracranial aneurysm with coils