Evaluation of DeltaMaxx® Microcoil System in Intracranial Aneurysms

Intracranial Aneurysms Clinical Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01945827
• Other study ID #: CD-000036-PRO
• Status: Withdrawn
• Phase: N/A
• First received: September 12, 2013
• Last updated: July 2, 2014
• Start date: January 2014

Study information

• Verified date: July 2014
• Source: Codman & Shurtleff
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Aneurysm
• Intracranial Aneurysm
• Intracranial Aneurysms

Intervention

Device:
• DeltaMaxx Microcoil System

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Codman & Shurtleff

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Effectiveness Objective - Angiographic Outcomes	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	12 Months	No
Primary	Primary Safety Endpoint - Neurological Morbidity and Mortality	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	12 months	Yes
Secondary	Packing Density	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	24 hours	No
Secondary	Recurrence Rate		12 months	No
Secondary	Re-treatment Rate		12 months	No