Evaluation of DeltaMaxx® Microcoil System in Intracranial Aneurysms

NCT01945827 | Withdrawn

• 1 other identifier: CD-000036-PRO
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Intracranial Aneurysms

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (3)

• Packing Density

  24 hours

• Recurrence Rate

  12 months

• Re-treatment Rate

  12 months

Study Arms (1)

DeltaMaxx treated Patients

Device: DeltaMaxx Microcoil System

Interventions

DeltaMaxx Microcoil System DEVICE

DeltaMaxx treated Patients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects who have been diagnosed with a ≥ 6 mm intracranial aneurysm.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Codman & Shurtleff: lead

MeSH Terms

Conditions

Intracranial Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aneurysm; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2013
• First Posted: September 19, 2013
• Study Start: January 1, 2014
• Primary Completion: December 1, 2014
• Last Updated: July 3, 2014

Record last verified: 2014-07