NCT01084681

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)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Balt International · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	Endovascular treatment of intracranial aneurysms	Endovascular treatment with the SILK Artery Reconstruction Device for occluding intracranial aneurysms.
DEVICE	Endovascular treatment of intracranial aneurysm with coils	Endovascular treatment with commercially available intracranial coils for occluding intracranial aneurysms.

Timeline

• Start date: 2010-03-01
• Primary completion: 2012-10-01
• Completion: 2012-10-01
• First posted: 2010-03-10
• Last updated: 2011-06-08

Locations

1 site across 1 country: Germany