A Phase 4 interventional study of Flow Diversion and Coiling in Intracranial Aneurysm, sponsored by Medical University of South Carolina. Terminated at 1 site in United States. Open to participants aged 21 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-02-13.
Sponsored by Medical University of South Carolina · Phase 4, Interventional, and Treatment
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.
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.
427 studies on the registry are indexed under Intracranial Aneurysm; 115 are open to participants now.
This study's enrollment of 23 is below the median of 110 across 207 interventional studies indexed under Intracranial Aneurysm.
Browse Intracranial Aneurysm studies →Medical University of South Carolina is the lead sponsor of 852 studies on the registry; 165 are open to participants now.
Of its 128 completed or terminated interventional studies of FDA-regulated products, 101 (79%) have results posted.
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Patient has a single target IA that: is located in the following regions of the internal carotid artery:
4.2 Exclusion criteria
A screen failure log of all cases referred or presented for possible inclusion, but who were not randomized, and the reason(s) for exclusion will be maintained.
Coiling
Procedure: Coiling
Flow Diversion
Procedure: Flow Diversion
Endovascular flow diverter placement
Endovascular coil placement
The primary aim of aneurysm treatment is to achieve occlusion of the IA without morbidity or mortality.
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.
Time frame: approaximately 180 days after aneurysm treatement procedure
Incidence of device or procedure related adverse events at 180 days, 1 year and 3 years.
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.
Time frame: approximately 90 days, 180 days, 1 year, 2 year and 3 year
Subgroup analysis of clinical and angiographic outcomes in aneurysms 10-20 mm and > 2 cm.
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.
Time frame: approximately 3 years after aneurysm treatment procedure
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.
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
Time frame: 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.
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.
Time frame: 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.
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.
Time frame: 180 days
Number of inpatient hospital (and re-hospitalized) days (subgrouped >7 days) at 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
Time frame: 180 days, 1 year and 3 years.
Packing density as measured by volumetric filling of the aneurysm if aneurysm is coiled.
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.
Time frame: after initial procedure, day 0
Device cost of therapy at treatment and any subsequent retreatment.
Device cost of therapy at treatment and any subsequent retreatment will be counted and compared between groups in the study.
Time frame: 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.
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.
Time frame: approximately 6 years after the initial procedure
Subgroup analysis of clinical and angiographic outcomes in aneurysms intradural vs. extradural location
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.
Time frame: approximately 3 years after aneurysm treatment procedure
Subgroup analysis of clinical and angiographic outcomes in aneurysms reconstructive vs. deconstructive technique.
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.
Time frame: approximately 3 years after aneurysm treatment procedure
This study is terminated, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
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Medical University of South Carolina