CLINICAL RESEARCH

We are committed to improving patient outcomes by participating in clinical research trials so that science can define the truth.

BRAIN ANEURYSM TRIALS

NECC Trial

The purpose of this trial is to gather data on the safety and effectiveness of the Contour / Contour 021 System™ in the treatment of wide-necked bifurcated saccular, intracranial aneurysms for submission to FDA in support of a premarket approval application for the device. NCT04852783

Citadel Study

The purpose of this study is to gather preliminary safety and effectiveness data on Trenza Embolization Device™ in the treatment of wide-neck intracranial aneurysms. NCT04057352

WEB-PAS

A prospective, multicenter, single arm, interventional study for the WEB™ device. The target patient population for this study are adult subjects with wide-necked bifurcation aneurysms of the anterior and posterior intracranial circulation. The primary effectiveness outcome of the study is adequate intracranial aneurysm occlusion on the 1-year angiogram as adjudicated by a core laboratory. NCT04839705

FRED PAS Study

The objective of this study is to generate contemporaneous clinical data to facilitate a reasonable comparison of the performance of the FRED X™ device with the performance of the FRED™ device. The data generated from this study will be compared to the safety and effectiveness of the FRED™ device by meeting the same performance goals (PGs) established for the FRED™ pivotal study.

ISAT-2:

Is a trial designed to compare the open surgical treatment versus the endovascular treatment of historically difficult to treat by endovascular treatment ruptured aneurysms. This will include wide-necked aneurysms, very large aneurysms, and very small aneurysms. The endovascular treatments evaluated in the study include coiling, balloon assisted coiling, stent-assisted coiling, flow diverter stents, and intrasaccular flow disruptors.

Predictive model for long term disability for survivors of aneurysmal subarachnoid hemorrhage

This project is relevant to public health, as it will promote a better understanding of the relative influences social, clinical, and genetic factors have on disability after aSAH and will also give insight into the disparities for this outcome seen between Caucasian and African American patients. This trial is recruiting patients that have survived brain aneurysm rupture. It involves genetic testing and a questionnaire to see how disabled patients are after their aneurysm ruptured. If you are interested in participating in this trial please contact either myself David Altschul, MD at daltschu@montefiore.org or Aureliana Toma atoma@montefiore.org

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BRAIN AVMS TRIALS

TATAM:

The TATAM trial is evaluating the safety and efficacy of transvenous embolization for brain arteriovenous malformations. This will be directly compared against transarterial embolization

ACUTE ISCHEMIC STROKE TRIALS

Imperative Trial

Compare safety and efficacy of Zoom 88 and Zoom 71 devices for treatment of large vessel occlusion in storke

RESTORE Trial

Compare safety and efficacy of SOPHIA Plus and ERIC devices for treatment of large vessel occlusion in storke

PROST Trial:

Compare the safety and effectiveness of pRESET to Solitaire in the treatment of stroke related to large vessel occlusion.

ASSIST Stroke Registry:

ASSIST is a prospective, global, consecutive enrollment Registry of anterior circulation acute ischemic stroke patients with an LVO who undergo treatment with one of the interventional techniques using Stryker Neurovascular devices for the first pass. The purpose of this Registry is to assess the procedural success and clinical outcomes associated with various operator techniques for mechanical thrombectomy in large vessel occlusions (LVO) in the anterior circulation.

SUBDURAL HEMATOMA TRIALS

STEM Trial:

STEM Study is a pivotal, international, multi-center, prospective, randomized (1:1) controlled trial designed to provide an assessment of the safety and effectiveness of Middle Meningeal Artery (MMA) embolization with SQUID for the management of Chronic Subdural Hematoma (cSDH)

INTRACEREBRAL HEMORRHAGE (ICH) TRIALS

ENRICH Trial:

This is a multicenter, randomized, adaptive clinical trial comparing standard medical management to early (<24 hours) surgical hematoma evacuation using minimally invasive parafascicular surgery (MIPS) in the treatment of acute spontaneous supratentorial intracerebral hemorrhage.

ENDOVASCULAR MIGRAINE TRIALS

Understanding the pathophysiology of migraines:

The goal of this current work is to utilize the direct, real-time angiography, which provides a high resolution map of vasculature, and demonstrate changes in vessel flow in patients who have migraine headache attacks. This information may guide therapeutic interventions in the future in order to better treat these migraine patients.