LARGE Aneurysm Randomized Trial: Flow Diversion Versus Traditional Endovascular Coiling Therapy
Trial Snapshot
- Phase
- Phase 4
- Status
- Terminated
- Enrollment
- 23
- Locations
- 2
- Primary Endpoint
- The primary aim of aneurysm treatment is to achieve occlusion of the IA without morbidity or mortality.
Study Overview
Brief Summary
In this study, patients with large anterior circulation IAs with neck and fundus morphologies amenable to either traditional endovascular treatments using coils or reconstruction with the flow diversion will be randomly assigned to either treatment technique.
Detailed Description
This is a prospective, randomized trial comparing the endovascular coiling (endovascular coiling) versus the flow diversion for large and giant aneurysm treatment. The endovascular coiling used in this study are FDA-approved and in common use at institutions in this country and across the world. The flow diversion devices are FDA-approved for anterior circulation aneurysms >10 mm and are in common use at institutions in this country and across the world. Patients will be enrolled who meet the inclusion criteria and consent to participate. Patients will be randomly assigned by a central web-based system in a 1:1 manner to treatment with either endovascular coiling or flow diversion. Data on each patient will be collected at the time of enrollment and treatment, and at subsequent follow-up visits.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Coiling
Coiling
Intervention: Coiling (Procedure)
Flow Diversion
Flow Diversion
Intervention: Flow Diversion (Procedure)
Outcomes
Primary Outcomes
The primary aim of aneurysm treatment is to achieve occlusion of the IA without morbidity or mortality.
Time Frame: approaximately 180 days after aneurysm treatement procedure
Greater than 90% angiographic occlusion AND stable (or decreased) aneurysm size on cross sectional imaging (CT or MR) at 180 days post procedure. The primary objective is to show that flow diversion is non-inferior to endovascular coiling with respect to a combined efficacy and safety endpoint.
Secondary Outcomes
- Subgroup analysis of clinical and angiographic outcomes in aneurysms 10-20 mm and > 2 cm.(approximately 3 years after aneurysm treatment procedure)
- Incidence of device or procedure related adverse events at 180 days, 1 year and 3 years.(approximately 90 days, 180 days, 1 year, 2 year and 3 year)
- Downstream flow related ischemic stroke, parenchymal hemorrhage, subarachnoid hemorrhage, aneurysm rupture or re-treatment of index aneurysm rates at 180 days, one year and 3 years.(approaximately 180 days, 1 year, and 3 years after aneurysm treatement procedure)
- Change in clinical functional outcome at 180 days, 1 year and 3 years post-endovascular treatment procedure, as measured by an increase in the modified Rankin Scale from baseline.(180 days, 1 year and 3 years post-endovascular treatment procedure)
- Incidence of worsening of baseline neurological signs/symptoms as measured by NIHSS/ophthalmologist exam related to target intracranial aneurysm (IA) at 180 days.(180 days)
- Number of inpatient hospital (and re-hospitalized) days (subgrouped >7 days) at 180 days, 1 year and 3 years.(180 days, 1 year and 3 years.)
- Packing density as measured by volumetric filling of the aneurysm if aneurysm is coiled.(after initial procedure, day 0)
- Device cost of therapy at treatment and any subsequent retreatment.(approximately 6 years after the initial procedure)
- Procedure time, as measured as the time from placement of the treating guide catheter for purposes of aneurysm treatment until guide catheter removal.(approximately 6 years after the initial procedure)
- Subgroup analysis of clinical and angiographic outcomes in aneurysms intradural vs. extradural location(approximately 3 years after aneurysm treatment procedure)
- Subgroup analysis of clinical and angiographic outcomes in aneurysms reconstructive vs. deconstructive technique.(approximately 3 years after aneurysm treatment procedure)