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Clinical Trials – Treatments for Aneurysm

Dr. Lopes participates in the following clinical trials that explore treatments for aneurysm.

For more information about these trials, please call our Research Coordinator at 312-942-1489.

Coils: ACE: An Aneurysm Coiling Efficiency Study of the Penumbra Coil 400 System
This is a prospective, multi-center study of patients with intracranial or peripheral aneurysms who are treated by the PC 400 System. The primary objective is to gather post market data on the Penumbra Coil 400 (PC 400) System in the acute treatment of intracranial and peripheral aneurysms. Read more at clinicaltrials.gov.

Drug: Estrogen Therapy as Prevention in the Progression of Aneurysm (EPPA) Trial
This study aims to determine if hormone replacement therapy, given during perimenopause may prevent the progression of saccular cerebral aneurysms. Read more at clinicaltrials.gov.

Flow Diverter: Premier Prospective Study on Embolization of Intracranial Aneurysms with Pipeline™ Embolization Device
The purpose of this study is to assess the safety and effectiveness of the Pipeline™ device in the treatment of unruptured, wide-neck intracranial aneurysms. Read more at clinicaltrials.gov.

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Surpass Flow Diverter

Flow Diverter: The Surpass IntraCranial Aneurysm Embolization System Pivotal Trial to Treat Large or Giant Wide-Neck Aneurysms (SCENT)
This clinical research study is designed to determine safety and effectiveness of the Surpass Flow Diverter (Surpass System), an investigational device developed to treat wide neck, large or giant intracranial aneurysms. An intracranial aneurysm is a bulge in the wall of a blood vessel in the brain. The bulge is caused by a weakening of the vessel wall. If left untreated, the bulge may continue to grow larger and ultimately the vessel may break open (rupture), resulting in serious bleeding into our around the brain. The information collected from this study will be used to evaluate how well patients do when treated with the Surpass System both immediately after treatment of an aneurysm and over a long period of time (5 years). Read more at clinicaltrials.gov.

Flow Diverter: Pivotal Study of the FRED Stent System in the Treatment of Intracranial Aneurysms
The purpose of this study is to evaluate the safety and effectiveness of the MicroVention Flow Redirection Intraluminal Device (FRED) system when used in the treatment of wide-necked intracranial aneurysms. Read more at clinicaltrials.gov.

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WEB™ Aneurysm Embolization System

Flow Diverter: The WEB® Intrasaccular Therapy Study (WEB-IT)
The study is a prospective, multicenter single-arm cohort. Patients with wide neck bifurcation aneurysms (WNBAs) have few choices for safe and effective endovascular treatment. In this study, all patients with qualifying WNBAs will be treated with the WEB. The primary effectiveness outcome of the study is the likelihood of complete intracranial aneurysm occlusion on the 1 year angiogram as adjudicated by a core laboratory. Read more at clinicaltrials.gov.

Flow Diverter: Aneurysm Study Of Pipeline in an Observational Registry
The primary objective of this study is to further expand the body of clinical knowledge in patients undergoing Pipeline Embolization Device (Pipeline or PED) placement for intracranial aneurysms (IAs or ICAs) according to Pipeline’s labeled indication. Read more at clinicaltrials.gov.

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Penumbra Liberty Stent

Stent: The Penumbra Liberty Trial: Safety and Effectiveness in the Treatment of Wide-Neck Intracranial Aneurysms
To assess the safety and effectiveness of the Penumbra Liberty Stent System as adjunctive treatment to embolic coils for wide-neck, saccular, intracranial aneurysms in the internal carotid artery (ICA). The Liberty Stent System is an implantable device comprised of a stent and delivery system designed as an adjunct to embolic coils in the treatment of wide-neck, saccular, intracranial aneurysms. It has three components: an implant, an introducer sheath and a delivery wire assembly. Read more at clinicaltrials.gov.

Stent: Pivotal Study of the LVIS (Low Profile Visualized Intraluminal Support)
The purpose of this study is to evaluate the safety and efficacy of the Low Profile Visualized Intraluminal Support(LVIS™ and LVIS™ Jr.)devices from MicroVention, Inc. when used to facilitate endovascular coiling of wide-necked intracranial aneurysms with coils. Read more at clinicaltrials.gov.

Vascular Reconstruction: Multi-center Non-randomized Clinical Investigation of the Reverse Medical Barrel™ Vascular Reconstruction
Device (VRD) for Adjunctive Treatment to Embolic Coils for Wide Neck Intracranial Bifurcation and Branch Aneurysms
The purpose of this clinical investigation is to evaluate the safety and effectiveness of the Barrel™ VRD when used to facilitate endovascular coiling of wide-neck bifurcating or branch intracranial aneurysms with any approved embolic coils. Read more at clinicaltrials.gov.