The Surpass intracranial aneurysm embolization system pivotal trial to treat large or giant wide neck aneurysms

Completed

• Conditions: aneurysm; bulge; 10002363

• Registration Number: NL-OMON39950
• Lead Sponsor: Boston Biomedical Associates

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

age 19-80 years
subject has a single targeted intracranial aneurysm that:
- located in the internal carotid artery distribution up to the terminus
-is able to cross with a standard 0,014guide wire
-has a neck > 4mm or no discernible neck and an aneurysm size > 10mm

Exclusion Criteria

- known allergy or contraindication to Aspirin, Clopidogrel/Plavix, heparin,local or general anesthesia.
- known history of life threathening allergy to contrast dye
- More than one intracranial aneurysm that requires treatment within 12 months
- unstable neurological deficit
- extra-cranial stenosis or parent vessel with stenosis > 50% in the area proximal to the aneurysm

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary efficacy endpoint is the percent of subjects with 100% occlusion<br /><br>(Raymond Class 1) without clinically significant stenosis (defined as < 50%<br /><br>stenosis) of the parent artery based on core lab evaluation of the 12 month<br /><br>follow up angiogram and without any subsequent treatment at the target aneurysm<br /><br>at the 12 month follow up visit</p><br>