A Clinical Study Evaluating the Safety and Efficacy of BS054 Combined with Coil Embolization as a Treatment of Unruptured Wide Neck Intracranial Aneurysm - BS054

Boston Scientific Japan K.K.0 sites20 target enrollmentSeptember 9, 2009

Overview

No summary available.

Registry

who.int

Start Date

September 9, 2009

End Date

May 31, 2011

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

•1\)Unruptured wide neck intracranial aneurysm
•2\)The parent artery diameter within the range of 2\.0 to 4\.5 mm.
•3\)The target intracranial aneurysm is difficult to be treated by surgery and coil embolization with the use of embolization coils alone.

•1\)The target intracranial aneurysm has a history of rupture.
•2\)Stent implantation in the neck or cranium within 4 weeks before the study procedure.
•3\)Two or more untreated intracranial aneurysms with the maximum diameters of \>\= 10 mm.
•4\)The access of the Stent to the target intracranial aneurysm is considered impossible anatomically or procedurally by angiography, or the access to the intracranial aneurysm is impossible because of severe vasospasm refractory to medications.
•5\)The patient has hemorrhagic diathesis.
•6\)Antiplatelet/anticoagulation therapy is contraindicated.
•7\)The patient has a complication of a disease condition causing cardiogenic cerebral infarction.
•8\)Renal failure (serum creatinine \>\= 2\.0 mg/dL).