10 studies found

ENRICH: Early MiNimally-invasive Removal of IntraCerebral Hemorrhage (ICH)

The ENRICH trial will compare the outcomes between early surgical intervention using the BrainPath® Approach (i.e., MIPS) and a medically managed cohort. The integrated surgical approach includes a combination of available technologies, including the FDA-cleared NICO BrainPath® for non-disruptive access and NICO Myriad® to achieve the goal of maximum clot...

Best Endovascular vs. Best Surgical Therapy in Patients With Critical Limb Ischemia

Male and female subjects aged 18 years or older will be randomized to receive either open surgical treatment or endovascular treatment. They will be followed for at least 2 years and up to 4 years and 2 months after treatment to primarily assess survival and major adverse limb events in...

COAST: Coiling of Aneurysms Smaller Than 5mm With Hypersoft® and Hydrogel Coils

1.0 INTRODUCTION 1.1 Background Intracranial aneurysms (IAs) are common cerebrovascular abnormalities. The prevalence of IAs has been reported to be 0.8-2.0% of the population. [1-3] The most common presentation of IAs is subarachnoid hemorrhage (SAH), the annual incidence of which varies by geographic region from 10 to 20 per 100,000....

Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial

Prevention of stroke involves managing and treating risk factors. Most strokes are caused when blood flow to a portion of the brain is blocked. One place this often happens is in the carotid artery. This blockage is called atherosclerosis or hardening of the arteries. The purpose of this trial is...

Supporting Patients Undergoing HIgh-Risk PCI Using a High-Flow PErcutaneous Left Ventricular Support Device (SHIELD II)

Prospective, randomized, multi-center, open-label trial of the HeartMate PHP at up to 120 sites in the US and Europe. Control device will be any Abiomed Impella device approved for use in high-risk PCI. This clinical investigation is divided into two phases, a feasibility phase and a pivotal phase. - Feasibility...

Multi-CenTer Experience With the Rapid Deployment EDWARDS INTUITY Valve System FOR Aortic Valve ReplaceMent

This is a prospective, non-randomized, multi-center trial. Up to 950 subjects will be enrolled at up to 35 centers in the US. After re-placement of their aortic heart valve with the EDWARDS INTUITY valve system, each patient will have routine follow-up tests at the following intervals: discharge, 3 months, 1...

Portico Re-sheathable Transcatheter Aortic Valve System US IDE Trial

The PORTICO IDE trial will include approximately 758 randomized subjects at up to 70 investigational sites. The study is powered to analyze the high risk cohort and extreme risk cohort together against a commercially available control for the primary safety and effectiveness endpoints. In addition, data for each cohort will...

Osimertinib With or Without Bevacizumab in Treating Patients With EGFR Positive Non-small Cell Lung Cancer and Brain Metastases

PRIMARY OBJECTIVE: I. To determine the progression-free survival with AZD9291 (osimertinib) plus bevacizumab compared to AZD9291 (osimertinib) alone. SECONDARY OBJECTIVES: I. To assess the safety and tolerability of the combination of AZD9291 (osimertinib) and bevacizumab. II. To evaluate the time to progression in the central nervous system (CNS) with AZD9291...

Onvansertib in Combination With FOLFIRI and Bevacizumab for Second Line Treatment of Metastatic Colorectal Cancer Patients With a Kras Mutation

The purpose of the Phase 1b/2 study is to determine the safety and efficacy of Onvansertib, administered orally, daily, for 5 consecutive days on Day 1-5 of each 14-day course in each 28-day cycle, in combination with FOLFIRI + Avastin, as second-line treatment in adult patients who have metastatic colorectal...

Stereotactic Body Radiation Therapy or Intensity-Modulated Radiation Therapy in Treating Patients With Stage IIA-B Prostate Cancer

PRIMARY OBJECTIVES: I. To determine whether stereotactic body radiation therapy (SBRT) can be shown to be superior to hypofractionated intensity-modulated radiation therapy (IMRT) in terms of genitourinary (GU) and gastrointestinal (GI) toxicity by having fewer patients that experience a minimal important decline (MID) in urinary irritation/obstructive and bowel Health Related...