HydroCoil Cerebral Aneurysm Treatment Trial

Phase 4

Terminated

• Conditions: Intracerebral Aneursym
• Interventions: Device: Non-hydrogel coils; Device: MicroVention Hydrogel coil

• Registration Number: NCT01195129
• Lead Sponsor: University of Virginia

Brief Summary

The study will compare clinical and angiographic outcomes in patients receiving Hydrocoil aneurysm treatment versus patients receiving non-HydroCoil aneurysm treatment.

Detailed Description

With prospective, randomized trials in progress evaluating the effectiveness of Hydrocoils and Cerecyte coils in comparison to bare platinum coils, the next step is a direct comparison of Hydrocoils and non-HydroCoils (Cerecyte or Platinum). Considering the increased costs to society of treatment with these new coils, it is essential that the benefits of the new technology are properly evaluated against the existing platinum coil technology in a scientifically valid manner.

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2010-09-02
• Study First Submitted QC: 2010-09-02
• Study First Posted: 2010-09-03
• Primary Completion: 2013-04
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-11
• Last Update Posted: 2014-12-12
• Study Completion: 2015-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 215

Inclusion Criteria

1. Patient presenting with a ruptured or un-ruptured cerebral aneurysm appropriate for endovascular treatment as determined by the neurovascular team (neurosurgeon/neurointerventionalist)
2. The neurointerventionalist believes that the aneurysm can be safely treated with either Cerecyte or Hydrogel.
3. Patients between (and including) 21 and 90 years of age.
4. Patient HUNT AND HESS Grade 0-3.
5. Patient has given fully informed consent to endovascular coiling procedure. If patient cannot consent for themselves, appropriate written consent has been sought from their next of kin, or from appropriate power of attorney.
6. Aneurysm 5-20mm in maximum diameter.
7. Patient is willing and able to return for clinical evaluation and follow-up imaging evaluation (angiography or MRA) at both 6-months and 12-18 months after endovascular treatment.
8. The patient has not been previously randomized into this or another related ongoing trial.
9. The aneurysm has not previously been treated (by coiling or clipping).

Exclusion Criteria

1. Patient has more than one aneurysm requiring treatment in the current treatment session If a patient has multiple aneurysms, but only one will be treated at the time of enrollment, they are eligible for the trial. (Additional aneurysms may be treated at a later date, and may be treated with any coil type that the operator chooses).

2. Target aneurysm has had previous coil treatment or surgically clipped.

3. Patient has an H&H score of 4 or 5 after subarachnoid hemorrhage (SAH).

4. Inability to obtain informed consent.

5. Medical or surgical co-morbidity such that the patient's life expectancy is less than 1 year.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-hydrogel coils	Non-hydrogel coils	Cerecyte or bare platinum coils (FDA approved and in common use for treatment of cerebral aneurysm).
MicroVention Hydrogel Coils	MicroVention Hydrogel coil	FDA approved and in common use for cerebral aneurysm treatment.

Primary Outcome Measures

Name	Time	Method
Occlusion rate	12 - 18 months	Angiographic occlusion, improvement or no change in the post-coiling appearance of the aneurysm as judged by an independent core lab on follow-up angiography at 12-18 months after endovascular treatment.

Secondary Outcome Measures

Name	Time	Method
Cost of treatment	12-18 months	Comparison of cost of treatment.
Clinical outcome	6 months	Clinical outcome as measured by Modified Rankin Scale
Treatment related morbidity and mortality	12-18 months	Treatment related morbidity and mortality, as measured by the NIH stroke scale;
Packing density	12-18 months	Packing density as measured by volumetric filling of the aneurysm.
Re-treatment rates	12-18 months	Comparison of re-treatment rates at 12-18 months post treatment.
Clinical Outcome	12-18 months	Clinical outcome as measured by the Modified Rankin scale
Re-bleed rates	12-18 months	Comparison of rebleed rates at 12-18 months

Trial Locations

Locations (11)

University of Florida; 🇺🇸 Gainesville, Florida, United States

Saint Louis University; 🇺🇸 St. Louis, Missouri, United States

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States

Oregon Health and Science University; 🇺🇸 Portland, Oregon, United States

Sentara Norfolk General Hospital; 🇺🇸 Norfolk, Virginia, United States

St. Luke's/Roosevelt Hospital Center; 🇺🇸 New York, New York, United States

University of Texas Southwest Medical Center; 🇺🇸 Dallas, Texas, United States

The Methodist Research Institute; 🇺🇸 Houston, Texas, United States

Mercy Stroke Center; 🇺🇸 Carmichael, California, United States

University of Southern California; 🇺🇸 Los Angeles, California, United States

Medical college of South Carolina; 🇺🇸 Charleston, South Carolina, United States