LARGE Aneurysm Randomized Trial: Flow Diversion Versus Traditional Endovascular Coiling Therapy
- Conditions
- Intracranial Aneurysm
- Interventions
- Procedure: Flow DiversionProcedure: Coiling
- Registration Number
- NCT01762137
- Lead Sponsor
- Medical University of South Carolina
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 23
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Flow Diversion Flow Diversion Flow Diversion Coiling Coiling Coiling
- Primary Outcome Measures
Name Time Method The primary aim of aneurysm treatment is to achieve occlusion of the IA without morbidity or mortality. 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 Outcome Measures
Name Time Method Subgroup analysis of clinical and angiographic outcomes in aneurysms 10-20 mm and > 2 cm. approximately 3 years after aneurysm treatment procedure A comparison will be made as a subgroup analysis of clinical and angiographic outcomes in aneurysms 10-20 mm and \> 2 cm. will be measured based on efficacy (Greater than 90% angiographic occlusion AND stable (or decreased) aneurysm size on cross sectional imaging (CT or MR) at 180 days post procedure) and Safety (Free of any major neurologic event (defined as change in NIHSS from baseline \> 4 points) downstream from target aneurysm, or death at 180 days post procedure) within this subgroup of study patients.
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 a count of the occurrences of device related Adverse Events will be recorded and compared between randomized groups at 90, 180, 1year, 2 year, and 3 year time points.
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 A count of occurrences of 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. will be measured and compared at each time point: 180 days, 1 year, and 3 year between groups
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 A comparison between groups will be conducted of change in modified rankin scale. The comparison will be measured by an increase in the modified Rankin Scale from baseline, 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.
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 A count and comparison of the incidence of worsening of baseline neurologic signs/symptoms as measured by national institutes of health stroke scale (NIHSS) or ophthalmological exam related to target IA at 180 days will be made between groups.
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. A count and comparison of the number of inpatient hospital (and re-hospitalized) days (subgrouped \>7 days) at 180 days, 1 year and 3 years will be performed between groups
Packing density as measured by volumetric filling of the aneurysm if aneurysm is coiled. after initial procedure, day 0 An analysis of packing density as measured by volumetric filling of the aneurysm if aneurysm is coiled will be performed. The analysis will show within group relationships and possible correlations among coiled patients and other variables.
Device cost of therapy at treatment and any subsequent retreatment. approximately 6 years after the initial procedure Device cost of therapy at treatment and any subsequent retreatment will be counted and compared between groups in the study.
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 Procedure time, as measured as the time from placement of the treating guide catheter for purposes of aneurysm treatment until guide catheter removal, will be collected, measured and compared between groups in the study.
Subgroup analysis of clinical and angiographic outcomes in aneurysms intradural vs. extradural location approximately 3 years after aneurysm treatment procedure A comparison will be made as a subgroup analysis of clinical and angiographic outcomes in aneurysms of intradural vs. extradural location and will be measured based on efficacy (Greater than 90% angiographic occlusion AND stable (or decreased) aneurysm size on cross sectional imaging (CT or MR) at 180 days post procedure) and Safety (Free of any major neurologic event (defined as change in NIHSS from baseline \> 4 points) downstream from target aneurysm, or death at 180 days post procedure) within this subgroup of study patients.
Subgroup analysis of clinical and angiographic outcomes in aneurysms reconstructive vs. deconstructive technique. approximately 3 years after aneurysm treatment procedure A comparison will be made as a subgroup analysis of clinical and angiographic outcomes in aneurysms treated with reconstructive vs. deconstructive technique and will be measured based on efficacy (Greater than 90% angiographic occlusion AND stable (or decreased) aneurysm size on cross sectional imaging (CT or MR) at 180 days post procedure) and Safety (Free of any major neurologic event (defined as change in NIHSS from baseline \> 4 points) downstream from target aneurysm, or death at 180 days post procedure) within this subgroup of study patients.
Trial Locations
- Locations (1)
MUSC
🇺🇸Charleston, South Carolina, United States