Evaluation of DeltaMaxx® Microcoil System in Intracranial Aneurysms

Codman & Shurtleff

Status: Withdrawn

Conditions: Intracranial Aneurysms

Treatments: Device: DeltaMaxx Microcoil System

Study type: Observational

Funder types: Industry

Identifiers

NCT01945827

CD-000036-PRO

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

0 participants in 1 patient group

DeltaMaxx treated Patients

Treatment:

Device: DeltaMaxx Microcoil System