Efficacy Trial of Intracranial Aneurysm Treatment Using Two Different Endovascular Techniques

NCT ID: NCT01084681

Last Updated: 2011-06-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2012-10-31

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.

Conditions

Intracranial Aneurysms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: ACTIVE_COMPARATOR

Endovascular treatment of intracranial aneurysms

Intervention Type: DEVICE

Endovascular treatment with the SILK Artery Reconstruction Device for occluding intracranial aneurysms.

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.

Group Type: ACTIVE_COMPARATOR

Endovascular treatment of intracranial aneurysm with coils

Intervention Type: DEVICE

Endovascular treatment with commercially available intracranial coils for occluding intracranial aneurysms.

Interventions

Endovascular treatment of intracranial aneurysms

Endovascular treatment with the SILK Artery Reconstruction Device for occluding intracranial aneurysms.

Intervention Type: DEVICE

Endovascular treatment of intracranial aneurysm with coils

Endovascular treatment with commercially available intracranial coils for occluding intracranial aneurysms.

Intervention Type: DEVICE

Other Intervention Names

Endovascular treatment of intracranial aneurysms

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Balt International

INDUSTRY

Sponsor Role: lead

Responsible Party

Balt International

Principal Investigators

Jacques Moret, MD

Role: STUDY_CHAIR

Beaujon Hospital - Paris Diderot University (Paris, France)

Locations

Universitätsklinikum Würzburg; Abteilung für Neuroradiologie

Würzburg, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Linda Nicolini, MBA

Role: CONTACT

linda.nicolini@balt.fr

+33 1 39894641

Alan Cohen, BS

Role: CONTACT

alanscohen@skynet.be

+32 473 865091

Facility Contacts

Linda Nicolini, MBA

Role: primary

linda.nicolini@balt.fr

+33 1 39894641

Alan Cohen, BS

Role: backup

alanscohen@skynet.be

+32 473 865091

Other Identifiers

Balt 2010-01

Identifier Type: -

Identifier Source: org_study_id