Evaluation of DeltaMaxx® Microcoil System in Intracranial Aneurysms

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01945827
Recruitment Status : Withdrawn
First Posted : September 19, 2013
Last Update Posted : July 3, 2014
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Intracranial Aneurysms Device: DeltaMaxx Microcoil System

Study Type : Observational [Patient Registry]
Actual Enrollment : 0 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Study Start Date : January 2014
Estimated Primary Completion Date : December 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
DeltaMaxx treated Patients Device: DeltaMaxx Microcoil System

Primary Outcome Measures :
  1. Primary Effectiveness Objective - Angiographic Outcomes [ Time Frame: 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

  2. Primary Safety Endpoint - Neurological Morbidity and Mortality [ Time Frame: 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 :
  1. Packing Density [ Time Frame: 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

  2. Recurrence Rate [ Time Frame: 12 months ]
  3. Re-treatment Rate [ Time Frame: 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Subjects who have been diagnosed with a ≥ 6 mm intracranial aneurysm.

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

Responsible Party: Codman & Shurtleff Identifier: NCT01945827     History of Changes
Other Study ID Numbers: CD-000036-PRO
First Posted: September 19, 2013    Key Record Dates
Last Update Posted: July 3, 2014
Last Verified: July 2014

Additional relevant MeSH terms:
Intracranial Aneurysm
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases