NCT01762137TerminatedPhase 4
LARGE Aneurysm Randomized Trial: Flow Diversion Versus Traditional Endovascular Coiling Therapy
Medical University of South Carolina1 site in 1 country23 target enrollmentStarted: February 1, 2013Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 4
- Status
- Terminated
- Enrollment
- 23
- Locations
- 1
- 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
- •Age 21 to 75 years, inclusive
- •Patient has a single target IA that: is located in the following regions of the internal carotid artery:
- •Paraophthalmic (including paraclinoid, ophthalmic and hypophyseal segments)
- •has a parent vessel with diameter 2.5-5.0 mm
- •Wide neck aneurysm ≥4 mm.
- •Target IA has size (maximum fundus diameter) 10 mm
- •The operator feels that the aneurysm can be appropriately treated with traditional endovascular techniques (endovascular coil embolization with or without adjunctive devices or parent artery deconstruction) using endovascular coiling or flow diversion devices.
- •Modified Rankin Scale 0-3
- •Signed and dated informed consent
Exclusion Criteria
- •More than one IA requiring treatment in the next 6 months
- •Subarachnoid hemorrhage in the past 60 days
- •Any intracranial hemorrhage in the last 42 days
- •Major surgery (requiring general anesthesia) in the last 42 days
- •Coils in place in the target IA
- •Unstable neurologic deficit (i.e., any rapidly worsening clinical condition in the last 30 days (defined by a change in mRS of 2 or more))
- •Known irreversible bleeding disorder
- •Platelet count < 100 x 103 cells/mm3 or known platelet dysfunction
- •Clinically documented evidence in medical history of adverse reaction or contraindication to medications used in treatment of the aneurysm (i.e. Plavix, heparin, aspirin)
- •Prior stent placement at target site
- •Documented history of dementia
- •Contraindication to CT scan and MRI (ie. contrast allergy, or other condition that prohibits imaging from either CT or MRI)
- •Known allergy to contrast used in angiography that cannot be medically controlled
- •Known severe allergy to platinum or cobalt/chromium alloys
- •Relative contraindication to angiography (e.g., serum creatinine > 2.5 mg/dL)
- •Pregnancy, breast-feeding, or positive pregnancy test [either serum or urine] (Woman of child-bearing potential must have a negative pregnancy test prior to the study procedure.)
- •Evidence of active infection (indicated by fever [at or over 99.9 °F] and/or open draining wound) at the time of randomization
- •Other known conditions of the heart, blood, brain or intracranial vessels that carry a high risk of neurologic events (e.g., severe heart failure, atrial fibrillation, known carotid stenosis)
- •Current use of cocaine or other illicit substance
- •Any comorbid disease or condition expected to compromise survival or ability to complete Follow-up assessments through 180 days
- •Extracranial stenosis greater than 50% in the carotid artery
- •Intracranial stenosis greater than 50% in the treated vessel
- •Based on investigator's judgment, patient does not have the necessary mental capacity to participate or is unwilling or unable to comply with protocol follow up appointment schedule.
- •"Previously randomized into this trial or currently participating in another trial where the data is intended to be used to obtain marketing approval or to broaden an indication, without the approval of the study principal investigator, that may confound the results of this study.
- •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.
Arms & Interventions
Coiling
Active Comparator
Coiling
Intervention: Coiling (Procedure)
Flow Diversion
Active Comparator
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)
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Completed
Not Applicable
Effect of Pre-operative Exercise in Abdominal Aortic Aneurysms (AAA) Patients.Abdominal Aortic AneurysmNCT01062594Hull University Teaching Hospitals NHS Trust124
Active, not recruiting
Not Applicable
Evaluation of Safety and Effectiveness of Stryker Surpass Evolve™ Flow Diverter SystemAneurysm, IntracranialNCT04195568Stryker Neurovascular248
Completed
Unknown
Study of functional outcomes of ruptured large/giant intracranial aneurysms from multicenter databaseruptured cerebral aneurysmJPRN-UMIN000051115Kochi University416
Completed
Not Applicable
Hemodynamic Analysis for Intracranial Aneurysms Recanalization After Endovascular TreatmentIntracranial AneurysmNCT02812108Beijing Neurosurgical Institute200
Completed
Not Applicable
Stenting in the Treatment of Aneurysm TrialIntracranial AneurysmNCT01340612Centre hospitalier de l'Université de Montréal (CHUM)205