Overview

This trial is active, not recruiting.

Condition cerebral aneurysms
Sponsor Mayo Clinic
Collaborator Abbott
Start date August 2009
End date June 2016
Trial size 114 participants
Trial identifier NCT01000675, 09-002933

Summary

The current proposal describes a post-market, clinical registry of HydroSoft, aimed at gaining robust clinical data in a large set of patients to better define the advantages, and potentially, the disadvantages of the HydroSoft, and to inform future randomized trials.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Time perspective prospective

Primary Outcomes

Measure
We will compare recanalization or recurrence rates observed in this prospective registry of HydroSoft coils used as finishing coils to historical series of aneurysms treated with bare platinum coils.
time frame: 6 - 18 months post coiling

Secondary Outcomes

Measure
HydroSoft embolic coil can be placed reliably in intracranial, saccular aneurysms, even late in the embolization procedure.
time frame: 6 - 18 months post coiling

Eligibility Criteria

Male or female participants from 21 years up to 90 years old.

Inclusion Criteria: 1. Patient presenting with a ruptured or un-ruptured cerebral aneurysm appropriate for endovascular treatment as determined by the neurovascular team (neurosurgeon/neurointerventionist) 2. Patient age: patients aged between 21 and 90 years will be eligible. 3. Patient HUNT AND HESS Grade 0-3. 4. Patient has given fully informed consent to endovascular coiling procedure or if patient cannot consent for themselves, appropriate written consent has been sought from their next of kin, or from appropriate power of attorney. 5. Aneurysm 3-15mm in maximum diameter. 6. Patient is willing and able to return for follow up angiography or MRA between 6-18 months. 7. The patient has not been previously entered into this registry 8. The aneurysm has not previously been treated (by coiling or clipping). Exclusion Criteria: 1. Inability to obtain informed consent. 2. Medical or surgical comorbidity such that the patient's life expectancy is less than 1 year.

Additional Information

Official title Gaining Efficacy Long Term: Hydrosoft, an Emerging, New, Embolic Coil (Gel-the-nec)
Principal investigator David F Kallmes, MD
Description Aim 1. (Primary Outcome) To test the hypothesis that HydroSoft coils lead to diminished rates of aneurysm recurrence relative to bare platinum coils. In order to test this hypothesis, we will compare recanalization or recurrence rates observed in this prospective registry of HydroSoft coils used as finishing coils to historical series of aneurysms treated with bare platinum coils. This registry is designed to achieve 80% power to detect a minimally clinically relevant difference in rates of recurrence between HydroSoft-treated aneurysms compared with bare platinum coils. Based on recent, prospective, randomized trials assessing both bare platinum coils and hydrogel-bearing coils with 25% and 15% recurrence rates, respectively, we predict a recurrence rate of 18% for HydroSoft treated aneurysms. Typically, a "minimally clinically relevant difference" is on the order of a 30% diminution in a given undesirable outcome. As such, the registry is well powered to detect this minimally clinically relevant difference (18% expected recurrence rate for HydroSoft treated coils versus 25% for the historical control group). Aim 2. (Secondary Outcome 1) To test the hypothesis that the HydroSoft embolic coil can be placed reliably in intracranial, saccular aneurysms, even late in the embolization procedure. Success of this aim is defined as ease of placement of the HydroSoft device, without need for coil removal and subsequent "finishing" with a bare platinum coil. Aim 3. (Secondary Outcome 2) To test the hypothesis that use of the HydroSoft embolic coil is associated with risks of thromboembolism similar to that with other coil types, on the order of 3-5% or less.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Mayo Clinic.