Evaluation of DeltaMaxx® Microcoil System in Intracranial Aneurysms

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Codman & Shurtleff
ClinicalTrials.gov Identifier:
NCT01945827
First received: September 12, 2013
Last updated: July 2, 2014
Last verified: July 2014
  Purpose

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 Intervention
Intracranial Aneurysms
Device: DeltaMaxx Microcoil System

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months

Resource links provided by NLM:


Further study details as provided by Codman & Shurtleff:

Primary Outcome Measures:
  • Primary Effectiveness Objective - Angiographic Outcomes [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    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:
  • Packing Density [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    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

  • Recurrence Rate [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Re-treatment Rate [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: January 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
DeltaMaxx treated Patients Device: DeltaMaxx Microcoil System

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Codman & Shurtleff
ClinicalTrials.gov Identifier: NCT01945827     History of Changes
Other Study ID Numbers: CD-000036-PRO
Study First Received: September 12, 2013
Last Updated: July 2, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 21, 2014