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Clinical Trials - Stroke and Neurovascular Center

The Stroke and Neurovascular Center currently has more than 10 ongoing trials. Most of these trials are large multicenter ventures with the National Institute of Health and the National Institute of Neurological Diseases and Stroke (NINDS). There are some trials that are sponsored by device companies and pharmaceutical companies. The Stroke and Neurovascular Center is virtually a part of every important clinical trial.

To learn more, contact Charles Porbeni, Clinical Trials Coordinator, at 732-321-7000, ext. 68897.

Select Current Ongoing Trials:

CLEAR III

Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage Phase III.
This study is a multicenter, international, double-blind, randomized study comparing the use of EVD combined with rt-PA against EVD combined with placebo for the treatment of intraventricular hemorrhage.

Primary objectives: To define precisely the long-term effects of lysing ventricular blood clots with rt-PA on the functional outcomes of cerebral hemorrhage patients. We propose to test if this intervention promotes a recovery of function, as defined as a modified Rankin score of ≤ 3 at 180 days post ictus, by facilitating more rapid clot resolution as compared to treatment with extraventricular drainage (EVD) with placebo.

DIAS IV

A randomized, double-blind, parallel-group placebo-controlled phase lll study to evaluate the efficacy and safety of desmoteplase in subjects with acute ischemic stroke.

The study is designed to confirm the efficacy and further evaluate the safety of desmoteplase 90 μg/kg versus placebo in terms of favorable outcome at day 90 in subjects with acute ischemic stroke within 3 to 9 hours after the onset of symptoms. Desmoteplase, rDSPAα1 (recombinant Desmodus Salivary Plasminogen Activator alpha 1) is a glycoprotein produced in Chinese hamster ovary (CHO) cells and stored as a white lyophilisate. Its amino acid sequence is identical to its naturally occurring counterpart found in the saliva of Vampire Bat ( Desmodus. rotundus) and has 70% sequence identity with rt-PA.

ATACH II

Anti hypertensive Treatment of Acute Cerebral Hemorrhage (ATACH)-II. A Phase III Randomized Multicenter Clinical Trial of Blood Pressure Reduction for Hypertension in Acute Intracerebral Hemorrhage.

The study's primary objective is to determine the therapeutic benefit of intensive SBP treatment (SBP<140 mmHg) compared with standard SBP treatment (SBP<180 mmHg) in reducing the proportion of patients with death and disability (mRS of 4-6) at Day 90 among subjects with ICH treated within 3 hours of symptom onset.

Select Previous Trials:

MISTIE

Minimally Invasive Surgery plus rt-PA for ICH Evacuation: MISTIE

The MISTIE arms were designed to investigate the safety of minimally invasive surgery plus aspiration followed by the administration of a low dose of recombinant tissue plasminogen activator (rt-PA; Activase, Genentech, Inc., San Francisco, CA) to intracerebral hemorrhage patients (ICH) via a catheter/cannula inserted directly into the clot versus medical management.

The specific objective of this trial was to test the safety of these interventions and assess their ability to remove blood clot from brain tissue.

SENTIS

Safety and Efficacy of NeuroFlo Technology in Ischemic Stroke

The purpose of this study was to assess the safety and efficacy of the NeuroFlo catheter for use in patients with ischemic stroke. The NeuroFlo Catheter is intended to selectively control blood flow in the descending aorta in order to provide acute neurological improvement in patients experiencing ischemic stroke.

There were two primary study endpoints: one for safety and one for efficacy.

MACSI (MEMBRANE ACTIVATED CHELATOR STROKE INTERVATION)

A double blind, randomized, placebo-controlled, parallel group, multicenter Phase 3 pivotal study to assess the safety and efficacy of 1mg/kg/day intravenous DP-b99 over 4 consecutive days versus placebo when initiated within nine hours of acute ischemic stroke onset.

The primary objective of this study is to compare the clinical therapeutic effects of intravenous DP-b99 at a dose of 1.0 mg/kg initiated within nine hours of stroke onset and administered daily over 2 hours for 4 consecutive days versus placebo in subjects with moderately severe, likely hemispheric, acute ischemic stroke.

The secondary objectives of this study are to compare the safety and tolerability, as well as post-stroke recovery at Day 90, in subjects treated with DP-b99 versus placebo.

Basic and Translational Research:

The Stroke and Neurovascular Center has basic stroke science stroke models and biomaterials capabability in the state of the art animal laboratory with microsurgical capabilities. It also has a state of the art biomaterials basic research laboratory. Translational projects are performed under the auspices of a close SNC team collaboration with the basic science teams.

MicroRNA study

Expression of the microRNA’s is being studied to understand the events during acute ischemic stroke. This study is being conducted at Dr. Stephen Kelly’s laboratory.  

Acute Inflammatory Study

Clot retrieved in patients with acute ischemic stroke during neurointerventional surgery are studied for cytokine expression and acute soluble factors release in this study at Dr. Michelle Previtera’s laboratory.