Intracranial Aneurysmal Trials

1.  Aspirin Attenuates Inflammation in Human Cerebral Aneurysms

Randomized, single blinded trial evaluating use daily aspirin towards reduction of inflammation in cerebral aneurysmal wall, as monitored by macrophage generated ferumoxytol-enhanced MRI signal changes.  Study sponsor is the University of Iowa.  This study is currently recruiting participants.

2.  Brain and Abdominal Aneurysm Study (BAAS)

Prospective, case based observational study evaluating incidental presence of abdominal aortic aneurysms (AAA) in patients who present with aneurysmal subarachnoid hemorrhage.  Study sponsor is the Mayo Clinic.  This study is currently recruiting participants.

3.  The Canadian UnRuptured Endovascular Versus Surgery Trial,(CURES)

A prospective randomized comparison of angiographic and clinical outcomes following treatment for unruptured intracranial aneurysms by surgical versus endovascular therapy.  Study sponsor is the University of Alberta.  This study is currently recruiting participants.

4.  Estrogen Therapy as Prevention in the Progression of Aneurysm (EPPA) Trial

Randomized, double-blinded, placebo controlled trial to assess the effect of hormone replacement therapy (low dose estradiol), given during perimenopause for potential prevention of progression of saccular cerebral aneurysms, and monitored by radiographic means.  Study sponsor is the Rush University Medical Center.  This study is currently recruiting participants.

 5.  Flow Diverter Stent for Endovascular Treatment of Unruptured Saccular Wide-necked Intracranial Aneurysms (EVIDENCE)

A multicenter randomized study for medico-economic evaluation of embolization with Flow Diverter Stents vs coil embolization in the endovascular treatment of unruptured saccular wide-neck intracranial aneurysms larger than 7 mm.  Study sponsor is the Hospices Civils de Lyon.  This study is currently recruiting participants.

6.  Quality of Life in Elderly After Aneurysmal Subarachnoid Hemorrhage (SAH) (FASHE)

A prospective randomized Study of Quality of Life After Aneurysmal Subarachnoid Hemorrhage in Patients Aged 70 Years or Older by observation vs therapy with endovascular coil embolization or microsurgical clip ligation.  Study sponsor is the University Hospital, Rouen.  This study is currently recruiting participants.

7.  Framing Eighteen Coils in Cerebral Aneurysms Trial (FEAT)

Open label, randomized, device trial comparing angiographic outcomes in patients receiving Stryker Neurovascular 0.014-0.0155" platinum framing and filling coils versus those treated solely with coils less than 0.014".  Study sponsor is Vanderbilt University.  This study is currently recruiting participants.

8.  Flow Diversion in Intracranial Aneurysm Treatment

Randomized open label trial comparing flow diversion to best standard treatment in management of intracranial aneurysms, including conservative management; coiling with or without high porosity stenting; parent vessel occlusion with or without bypass or surgical clipping.  Study sponsor is the Centre hospitalier de l'Université de Montréal (CHUM).  This study is currently recruiting participants.

9.  Registry for Study of Coils in Intracranial Aneurysms (Gel-the-nec)

Prospective, open label, clinical registry comparing recanalization or recurrence rates with use of HydroSoft coils vs bare platinum coils.  Study sponsor is the Mayo Clinic.  This study is currently recruiting participants.

10.  Genome-wide Analysis of Single Nucleotide Polymorphisms of Brain Arteriovenous Malformations and Cerebral Aneurysm

Prospective, case controlled trial testing single nucleotide polymorphisms (SNP's) in ruptured and unruptured aneurysm tissue to identify a genetic difference between the two types of aneurysms; and in arteriovenous malformation tissue to identify a genetic link.  Study sponsor is the State University of New York - Upstate Medical University.  This study is currently recruiting participants.

11.  Hydrogel Endovascular Aneurysm Treatment Trial (HEAT)

Open label, randomized, device trial comparing angiographic outcomes in patients receiving bare platinum coils with the HydroCoil embolization system.  Study sponsor is Northwestern University.  This study is currently recruiting participants.

12.  International Subarachnoid Aneurysm Trial II (ISAT II)

Randomized, open label study comparing clinical outcomes of surgical clipping and endovascular coiling for ruptured intracranial aneurysms not included in the original ISAT study.  Study sponsor is the Centre hospitalier de l'Université de Montréal (CHUM).  This study is currently recruiting participants.

13.  LARGE Aneurysm Randomized Trial: Flow Diversion Versus Traditional Endovascular Coiling Therapy

A prospective, randomized, study comparing efficacy and safety of coil embolization vs flow diversion in large, anterior circulation intracranial aneurysms.  Study sponsor is the Medical University of South Carolina.  This study is currently recruiting participants.

14.  Pivotal Study of the LVIS(Low Profile Visualized Intraluminal Support)

An, open label, clinical efficacy and safety study of the Low Profile Visualized Intraluminal Support devices (Self-Expanding Retrievable Stent System) to facilitate endovascular coiling of wide-necked intracranial aneurysms.  Study sponsor is Microvention-Terumo, Inc.  This study is currently recruiting participants.

15.  The Penumbra Liberty Trial: Safety and Effectiveness in the Treatment of Wide-Neck Intracranial Aneurysms

A prospective, open label, multicenter clinical efficacy and safety study of the Penumbra Liberty Stent System as adjunctive treatment to embolic coils for wide-neck, saccular, intracranial aneurysms in the internal carotid artery.  Study sponsor is Penumbra Inc.  This study is currently recruiting participants.

16.  PRET: Patients Prone to Recurrence After Endovascular Treatment

A randomized, double blinded study comparing recurrence, efficacy and safety of coil embolization using traditional bare platinum vs hydrocoils.  Study sponsor is the Centre hospitalier de l'Université de Montréal (CHUM).  This study is currently recruiting participants.

17.  Remote Ischemic Preconditioning in Subarachnoid Hemorrhage (RIPC-SAH)

An open label, clinical efficacy and safety study of prophylactic remote ischemic preconditioning for vasospasm by transient lower limb ischemia in patients with aneurysmal subarachnoid hemorrhage following treatment of the aneurysm.  Study sponsor is the University of California, Los Angeles.  This study is currently recruiting participants.

18.  Safety and Effectiveness of an Intracranial Aneurysm Embolization System for Treating Large or Giant Wide Neck Aneurysms (SCENT)

Open label, device trial evaluating a flow diverter from Stryker Neurovascular towards treatment of large or giant wide-necked intracranial aneurysms in the internal carotid artery.  Study sponsor is Stryker Neurovascular.  This study is currently recruiting participants.

19.  Stenting in the Treatment of Aneurysm Trial (STAT)

Randomized open label trial comparing recurrence rates in coiling versus stent assisted coil embolization in large aneurysms, wide-necked aneurysms or recurring aneurysms after previous coiling.  Study sponsor is the Centre hospitalier de l'Université de Montréal (CHUM).  This study is currently recruiting participants.

20.  TARGET Intracranial Aneurysm Coiling Registry

A prospective, open label clinical efficacy and safety study of Stryker Target® 360° and Target® 2D Coils.  Study sponsor is the Medical College of Wisconsin.  This study is currently recruiting participants.

21.  TRUfill®'s Line in Intracranial aNeurysm Embolization (TRULINE)

A prospective, multicentric observational study evaluating the long term efficacy and safety of the CODMAN TRUFILL®'s line of coils in the endovascular treatment of intracranial aneurysms.  Study sponsor is Codman & Shurtleff.  This study is currently recruiting participants.