BS054 Clinical Study

Phase 3

Completed

• Conditions: Patients with unruptured wide-neck intracranial aneurysms

• Registration Number: JPRN-jRCT2092220032
• Lead Sponsor: Boston Scientific Japan K.K.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-09-09
• Study Completion: 2011-05-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

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.
etc.

Exclusion Criteria

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).
etc.

Study & Design

• Study Type: Interventional
• Study Design: Not specified