Research : Clinical Trials

Clinical Trials

The Miami Project to Cure Paralysis

The Department of Neurological Surgery is pursing various preclinical and clinical trial activities in conjunction with The Miami Project to Cure Paralyis.

It is anticipated that these activities will bring new and potentially life-changing treatments to people with central nervous system trauma. The clinical trials are curently divided into two concentrations: spinal cord injury and traumatic brain injury.

For a complete list of these clinical trials please visit the Clinical Trials Initiative.

Neurological Surgery

Brain Metastasis

Analysis of the mechanisms by which systemic cancers metastasize to the brain. The Department of Neurosurgery laboratory has identified a receptor protein produced by brain metastases from many different primary cancer types, which is not produced by most cancers that have not yet metastasized. The ligand (binding protein) for this receptor is also produced by brain metastases. The laboratory is currently performing experiments to more carefully analyze the roles of these proteins in brain metastasis. These proteins may be targets for future treatments of brain metastasis.

Brian Aneurysms

1. CODMAN ENTERPRISE™ Vascular Reconstruction Device and Delivery System

Study of patients with a ruptured or non-ruptured intracranial wide neck saccular aneurysm who are candidates for endovascular coil embolization. The CODMAN ENTERPRISE Vascular Reconstruction Device and Delivery System is a self-expanding, neurovascular stent and delivery system.

This is a prospective, non-randomized, feasibility study being conducted at five institutions in the United States. The goal of the study is to demonstrate the safety and feasibility of the CODMAN ENTERPRISE Vascular Reconstruction Device and Delivery System. 100 patients are being enrolled through Jackson Memorial Health Systems.

2. Onyx® Liquid Embolic System

A U.S. Investigational Device Exemption (IDE) study comparing Onyx to GDC coils is being conducted to evaluate the safety and effectiveness of embolization for intracranial aneurysms that, because of their morphology, location, or the patient’s medical condition, are considered to be very high risk for management by traditional operative techniques or inoperable.

The GDC coils are considered a reasonable reflection of contemporary procedures and practices for embolization of aneurysms and provided a baseline for comparison of patient outcome to Onyx® treated aneurysms.

The study has enrolled a total of 110 patients, 66 of these were treated with Onyx. The primary effectiveness endpoint thus far is six-month aneurysm occlusion ≥90% without retreatment.

3. Neuroform Microdelivery Stent System

There is currently no approved method for the treatment of wide-necked cerebral aneurysms. The FDA has designated the Neuroform Microdelivery Stent System as a Humanitarian Use Device (HUD), the use of which provides treating physicians with a tool to treat these difficult aneurysms that was previously not available.

The Neuroform Microdelivery Stent System is intended for use with embolic coils for the treatment of wide neck, intracranial, saccular aneurysms arising from a parent vessel that are not amenable to treatment with surgical clipping. 100 patients are being enrolled for the study through Jackson Memorial Health Systems and the University of Miami.

4. ev3 Researching AXIUM Coiling Experience and Recanalization (RACER) study

The AXIUM Coil Study is intended to survey the continuing safety and effectiveness of AXIUM Coils for the treatment of intracranial saccular aneurysms that are not amenable to treatment with surgical clipping. The intention is to fill the aneurysm with 100% AXIUM Coils. The Device has been used clinically at approximately 150 Institutions under FDA 510(k) approval since April 24, 2007. The device received CE approval on June 30, 2007. Through December 2007, greater than 1000 patients have been treated with the AXIUM Coils. An additional 15 subjects will be enrolledstudied as part of the study through Jackson Memorial Health Systems.

5. A prospective, multi-center, double-blind, randomized, placebo-controlled, parallel-group study to assess the efficacy and safety of clazosentan in reducing vasospasm-related morbidity and all-cause mortality in adult patients with aneurysmal subarachnoid hemorrhage treated by surgical clipping

The goal of the study is to demonstrate that clazosentan reduces the incidence of cerebral vasospasm-related morbidity and all-cause mortality within 6 weeks post-aneurysmal subarachnoid hemorrhage (aSAH) treated by surgical clipping.

A drug such as this is needed to prevent delayed ischemic effects including vasospasm-related cerebral infarction, reduce the amount of rescue therapy needed (HHH or angioplasty or any other intra-arterial treatment), and improve late outcome is highly desirable. 25 subjects are to be enrolled by Jackson Health Systems.

Intracranial Atherosclerotic Disease

Wingspan Stent System with Gateway Percutaneous Transluminal Angioplasty Balloon Catheter

The Wingspan Stent System with Gateway PTA Balloon Catheter is used to improve cerebral artery lumen diameter in patients with intracranial atherosclerotic disease, refractory to medical therapy, in intracranial vessels with >50% stenosis that are accessible to the system. Patients are considered eligible if they had present evidence of recurrent stroke.

The FDA has designated the Wingspan Stent System with Gateway PTA Balloon Catheter as a Humanitarian Use Device (HUD), the use of which provides treating physicians with a tool that was previously not available to treat intracranial lesions. The study is enrolling 50 subjects through the University of Miami.

Acute Ischemic Stroke (AIS)

Retrospective Analysis of Endovascular Therapy for Acute Ischemic Stroke: Importance of Pre-procedural Perfusion Studies

The purpose of the study is to determine the clinical outcomes of the impact of perfusion imaging after endovascular therapy for acute ischemic stroke (AIS).

The study anticipates that the selection of AIS patients with advanced perfusion imaging will lead to decreased intracerebral hemorrhage (ICH) as compared to AIS patients with non-contrast CT. The study is retrospectively reviewing all cases of acute anterior circulation ischemic stroke undergoing endovascular intervention at Jackson Memorial Hospital over a 28-month period. The study is determining the post-revascularization hemorrhagic transformation rate of acute ischemic stroke patients before and after the availability of advanced perfusion imaging at our institution.