Evaluation of DeltaMaxx® Microcoil System in Intracranial Aneurysms

Withdrawn

• Conditions: Intracranial Aneurysms
• Interventions: Device: DeltaMaxx Microcoil System

• Registration Number: NCT01945827
• Lead Sponsor: Codman & Shurtleff

Brief Summary

The primary objective of this registry is to assess the safety and angiographic outcomes of endovascular treatment of intracranial aneurysms using the DeltaMaxx Microcoil System.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-09-12
• Study First Submitted QC: 2013-09-18
• Study First Posted: 2013-09-19
• Study Start: 2014-01
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-02
• Last Update Posted: 2014-07-03
• Primary Completion: 2014-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Subject age ≥18 and ≤80 with a diagnosis of ruptured or unruptured intracranial aneurysm judged suitable for selective endovascular treatment by coil occlusion during single procedure
• Investigator intends to use DeltaMaxx Microcoil system during coiling procedure
• Investigator intends to use only Codman Neuro microcoils during coiling procedure
• Aneurysm size [largest measurement from the cross sectional images to determine overall aneurysm size, not just the lumen] ≥6 mm
• If ruptured aneurysm: Hunt and Hess 1, 2, or 3
• If unruptured aneurysm: Subject grade Modified Rankin Scale 0 - 2
• The subject or his/her Legally Authorized Representative must voluntarily provide Informed Consent for participation in this study and agree to return for all study visits.

Exclusion Criteria

• Prior treatment (surgical or endovascular) of the target aneurysm
• Subjects with more than one aneurysm (>2 mm) that have been treated with endovascular or clipping techniques in the past 30 days.
• Subject with social, medical or psychological conditions that interfere with treatment and follow-up evaluation
• Women who are pregnant or plan to become pregnant during the study
• Life expectancy less than 12 months.
• Presence of arteriovenous malformation
• Fusiform, mycotic, traumatic, or tumoral aneurysms
• Planned aneurysm treatment by parent vessel occlusion
• Subject enrolled in any concurrent study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
DeltaMaxx treated Patients	DeltaMaxx Microcoil System	-

Primary Outcome Measures

Name	Time	Method
Primary Effectiveness Objective - Angiographic Outcomes	12 Months	The Primary Effectiveness endpoint is the immediate post-procedure and 12-month angiographic occlusion rates assessed by the independent core lab using the modified Raymond-Roy Grading Scale (RRGS) scale
Primary Safety Endpoint - Neurological Morbidity and Mortality	12 months	Neurological Morbidity and Mortality as determined by the NIH Stroke Scale and all-cause mortality, regardless of relationship to the treatment, will be captured over the course of the study

Secondary Outcome Measures

Name	Time	Method
Recurrence Rate	12 months
Re-treatment Rate	12 months
Packing Density	24 hours	Packing density as measured by volumetric filling of the aneurysm post-procedure after the coils have been placed as indicated by angiographic films taken at the end of the coiling procedure