Peoria Radiology Research and Education Foundation

 

 CURRENT STUDIES

 

ENDOvascular Interventions With AngioMAX: The ENDOMAX Trial

Enrolling

Purpose: The primary objective of the study is to demonstrate that anticoagulation with bivalirudin results in fewer major bleeding complications compared with unfractionated heparin (UFH) in subjects undergoing peripheral endovascular interventions (PEI). The secondary objective is to identify potential benefits from bivalirudin therapy on other clinically important events such as death, myocardial infarction (MI), stroke and/or transient ischemic attack (TIA), amputation, unplanned repeat revascularization (URV), and minor bleeding, as well as potential economic benefits that may result from improved clinical outcomes.

Principal Investigator: H. Bob Smouse, MD
Sponsor: The Medicines Company

SENTRY Study

Enrolling

Purpose: The SENTRY Bioconvertible Inferior Vena Cava (IVC) Filter has been developed to provide temporary protection against pulmonary embolism (PE).
Principal Investigator: James Swischuk, MD
Sponsor: Novate Medical

Illinois Stroke Intervention Registry and Trials Network (ISIRTN)

Enrolling

Purpose: To create a local research network of academic university medical centers in the Chicago-Illinois wide area, practicing as comprehensive stroke centers with highly competent endovascular stroke intervention practices by establishing a multicenter, prospective clinical and imaging data registry of stroke intervention patients, centralized across this academic network.
Principal Investigator: Sean Meagher, MD
Sponsor: Non-sponsored/Academic

COOK IVC Filter Study (CIVC)

Enrolling

Purpose: This prospective, multicenter, single-arm clinical study will further evaluate the safety and effectiveness of Cook's permanent and retrievable inferior vena cava (IVC) filters (specifically, the Günther Tulip® Vena Cava Filter and Cook Celect® Vena Cava Filters) in patients in need of temporary or permanent IVC filter placement for the prevention of pulmonary embolism.

Principal Investigator: H. Bob Smouse, MD
Sponsor: COOK, Inc.

A Randomized, Concurrent Controlled Trial to Assess the Safety and Effectiveness of the Separator 3D as a Component of the Penumbra System in the Revascularization of Large Vessel Occlusion in Acute Ischemic Stroke

Enrolling

This is a prospective, randomized, concurrent controlled, multi-center study. Patients presenting with symptoms of acute ischemic stroke who have evidence of a large vessel (>3mm in diameter) occlusion in the cerebral circulation will be assigned to either the Penumbra System with the Separator 3D or the Penumbra System without the Separator 3D. Each treated patient will be followed and assessed for 3 months after randomization. Up to 164 evaluable patients at up to 50 centers presenting with acute ischemic stroke in vessels accessible to the Penumbra Separator 3D System for revascularization within 8 hours of symptom onset. The hypothesis to be tested is that the safety and effectiveness of the Penumbra System with the Separator 3D for the revascularization of large vessel occlusion is not inferior to the Penumbra System alone.
Principal Investigator: Sean Meagher, MD
Sponsor: Penumbra, Inc.

Format Clinical Trial

 In Follow-up

Purpose: The FORMAT Clinical Study is a clinical trial to evaluate the safety and effectiveness of the Formula™ 535 Iliac Balloon-Expandable Stent in treatment of symptomatic vascular disease of the iliac arteries.

Principal Investigator: H. Bob Smouse, MD
Sponsor: COOK, Inc.

Carotid Revascularization Endarterectomy versus Stenting Trial (CREST)

In follow-up

Purpose: The purpose the CREST Trial is to compare the relatively new procedure of stent-assisted carotid angioplasty (CAS) to the traditional and accepted surgical approach of carotid Endarterectomy (CEA) for the treatment of carotid artery stenosis to prevent recurrent strokes in those patients who have had a TIA (transient ischemic attack) or a mild stroke within the past 6 months (symptomatic) and in those patients who have not had any symptoms within the past 6 months (asymptomatic).

Principal Investigator: Kenneth Fraser, MD
Sponsor: NIH/Rutgers

Observational Study of tissue Plasminogen Activator Used for Catheter Directed Thrombolysis in Patients with Acute Lower Extremity Native Artery or Bypass Graft Occlusion

Pending IRB Approval

 Purpose: The objective of this observational study is to gain a better understanding of tPA dosing regimens and the resulting 30-45 day clinical outcomes in patients undergoing CDT directed thrombolysis.

Principal Investigator: H. Bob Smouse, MD
Sponsor: Grifols, Inc. 

Humanitarian Use Devices (HUDS) The HUD program creates an alternative pathway for getting market (FDA) for medical devices that may help people with rare diseases or conditions. These devices benefit patients in the treatment or diagnosis of a disease or condition that affects or is manifested in fewer than 4,000 individuals in the United States per year.

(Enterprise)Cordis Neurovascular Feasibility Study of the Enterprise Self-Expanding Stent System to Facilitate Endovascular Coil Embolization of Wide- Neck Saccular Intracranial Artery Aneurysms

Purpose: To evaluate the safety and feasibility of the Cordis Neurovascular Self-Expanding Stent System to facilitate endovascular coil embolization of wide neck saccular intracranial aneurysms.

Principal Investigator: Kenneth Fraser, MD
Sponsor: DePuy Synthes

(Neuroform)  Safety and Efficacy of Neuroform3™ for Intracranial Aneurysm Treatment

Purpose: This is a prospective observational registry, multicenter, with consecutive intent to treat to get safety and efficacy data on Neuroform3™ stent.
Principal Investigator: Kenneth Fraser, MD
Sponsor: Stryker Neurovascular

(Wingspan) An International Registry of the Wingspan™ Stent System for the Treatment of Intracranial Atherosclerotic Stenosis

The IRISS study is designed to collect clinical and angiographic outcomes data when stenting intracranial atherosclerotic lesions using the Wingspan™ Stent System with Gateway™ PTA Balloon Catheter in routine clinical practice.

Principal Investigator: Kenneth Fraser, MD
Sponsor: Stryker Neurovascular

For more information, contact: Stephanie Arthalony, CCRP @ sarthalony@cirarad.net or 309-655-7653