Treatment Trials

15 Clinical Trials for Various Conditions

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Bevacizumab Therapy for Brain Arteriovenous Malformation
Description

Bevacizumab Therapy for brain arteriovenous malformation that is not amenable to surgical intervention.

Conditions

Brain Arteriovenous Malformation

Genome-wide Analysis of Single Nucleotide Polymorphisms of Brain Arteriovenous Malformations and Cerebral Aneurysm
Description

Test single nucleotide polymorphisms (SNP's) in ruptured and unruptured aneurysm tissue to identify a genetic difference between the two types of aneurysms; and to test SNP's in arteriovenous malformation tissue to identify a genetic link.

Conditions

Arteriovenous Malformations, Intracranial Aneurysm, Subarachnoid Hemorrhage

Study Comparing Onyx and TRUFILL in Brain Arteriovenous Malformations (AVMs)
Description

Test whether AVMs treated with Onyx is equivalent to treatment with n-BCA. Success is defined as an AVM size reduction greater than 50%

Conditions

Brain Arteriovenous Malformations

Tetracycline-Derivatives for Treatment of Cerebral Arteriovenous Malformations and Aneurysms
Description

The purpose of this pilot study is to investigate the use of minocycline and doxycycline as medical therapy for inoperable or partially treated arteriovenous malformations (AVMs) and giant aneurysms.

Conditions

Aneurysms, Arteriovenous Malformations

Treatment of Brain AVMs (TOBAS) Study
Description

The objectives of this study and registry are to offer the best management possible for patients with brain arteriovenous malformations (AVMs) (ruptured or unruptured) in terms of long-term outcomes, despite the presence of uncertainty. Management may include interventional therapy (with endovascular procedures, neurosurgery, or radiotherapy, alone or in combination) or conservative management. The trial has been designed to test a) whether medical management or interventional therapy will reduce the risk of death or debilitating stroke (due to hemorrhage or infarction) by an absolute magnitude of about 15% (over 10 years) for unruptured AVMs (from 30% to 15%); and, b) to test if endovascular treatment can improve the safety and efficacy of surgery or radiation therapy by at least 10% (80% to 90%). As for the nested trial on the role of embolization in the treatment of Brain AVMs by other means: the pre-surgical or pre-radiosurgery embolization of cerebral AVMs can decrease the number of treatment failures from 20% to 10%. In addition,embolization of cerebral AVMs can be accomplished with an acceptable risk, defined as permanent disabling neurological complications of 8%.

Conditions

Unruptured Brain Arteriovenous Malformation, Ruptured Brain Arteriovenous Malformation, Arteriovenous Malformations, AVM, BAVM

Safety of Apollo Micro Catheter in Pediatric Patients
Description

This is a clinical trial/study for patients diagnosed with brain arteriovenous malformation (AVM). An AVM is an abnormal connection between the arteries and veins of the brain. Patients considered for this trial are 21 years and younger with AVM suitable for embolization treatment (a procedure used to block the abnormal connection between the arteries and veins of the brain) with Onyx Liquid Embolic System (Onyx LES) or TruFill n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System (both are liquid substances used in the embolization procedure to block the abnormal connection).

Conditions

Brain Arteriovenous Malformation, Brain Vascular Malformations, Vein of Galen Malformation

Comprehensive HHT Outcomes Registry of the United States (CHORUS)
Description

The Comprehensive HHT Outcomes Registry of the United States (CHORUS) is an observational registry of patients diagnosed with Hereditary Hemorrhagic Telangiectasia (HHT). The purpose of this study is to better understand HHT, the symptoms and complications it causes, and the impact the disease has on people's lives. The investigators will collect long-term information about the participant, allowing us to understand how the disease changes over time, and what factors can influence those changes. Ultimately, this should help improve treatments for the disease. Another important goal of the study is to provide a way to contact people to participate in future clinical trials and other research. The registry will be a centralized resource for recruitment for clinical trials. People in the registry will not be obligated to join any of these additional studies, but if interested, can agree to be contacted if they may be eligible for a study. Participants will: * Be asked to provide permission to collect information from their medical records, including things like demographic information, diagnosis information, family history, test results, treatment information, symptoms, complications, lifestyle and other relevant medical information. * Be asked study-related questions by phone or at a clinic visit. * Be asked study-related questions every year after enrollment for up to 10 years or until the study ends. A member of the study team will communicate with participants by phone or at clinic visits to collect information regarding any changes to their health over the previous year/s including new test results, treatment information, symptoms, and complications from HHT.

Conditions

Hereditary Hemorrhagic Telangiectasia, Arteriovenous Malformations, Telangiectasia, Epistaxis, GastroIntestinal Bleeding, Cerebral Arteriovenous Malformations, Vascular Malformation

Intraoperative Fluorescence With Augmented Reality
Description

This is a study looking at a new way to evaluate vascular problems or tumors in brain surgery patients using a standard \& approved intravenous dye and augmented reality.

Conditions

Vascular; Lesion, Central Nervous System, Brain Tumor, Cerebral Aneurysm, Cerebral AVM

Cerebral Hemorrhage Risk in Hereditary Hemorrhagic Telangiectasia
Description

This study is one of the three projects of an NIH Rare Disease Clinical Research Consortium. A "consortium" is a group of centres sharing information and resources to perform research. The consortium research focuses on brain blood vessel malformations in three different rare diseases. The focus of this specific study is on Hemorrhagic Telangiectasia (HHT). HHT is a condition characterized by blood vessel malformations, called telangiectasia and arteriovenous malformations (AVMs), occurring in the brain, nose, lungs, stomach, bowels and liver. Brain AVMs (BAVMs) in HHT are difficult to study because they are rare, affecting approximately 10% of people with HHT. While other types of BAVMs have been studied in depth, studies in the HHT population have been very small. Here, we propose the first large-scale collaboration by joining with 12 HHT Centers of Excellence in North America to perform a large study of risk factors for bleeding from BAVMs, called intracranial hemorrhage (ICH) in HHT patients. The current standard of clinical practice across North America, is to screen all HHT patients for BAVMs with magnetic resonance imaging (MRI). If BAVMs are detected, patients are referred to a multidisciplinary neurovascular team for consideration for treatment. Treatment decisions are made on a case by case basis, balancing risks of complications from the BAVM with risks of therapy, but are limited by the few studies available in HHT. We hope that the knowledge we obtain about the risk factors for intracranial bleeding in these patients from this larger study will help us to improve the care of HHT patients. We plan to study risk factors for rupture of BAVMs, including primarily genetics and imaging characteristics of the BAVMs. Knowledge about risk factors will help in the care and management of HHT patients. This will be achieved through the collection of health information to construct a HHT database, blood sampling and banking (through the National Institute of Neurological Disorders and Stroke \[NINDS\]), and through genetic analysis at the University of California San Francisco.

Conditions

Hereditary Hemorrhagic Telangiectasia

A Randomized Trial of Unruptured Brain AVMs
Description

The purpose of this study is to determine if medical management is better than invasive therapy for improving the long-term outcome of patients with unruptured brain arteriovenous malformations.

Conditions

Arteriovenous Malformations, Cerebral

Intraoperative Laser Speckle Contrast Imaging of Cerebral Blood Flow
Description

The purpose of this research study is to evaluate the ability of laser speckle contrast imaging to visualize blood flow in real time during neurosurgery. Real-time blood flow visualization during surgery could help neurosurgeons better understand the consequences of vascular occlusion events during surgery, recognize potential adverse complications, and thus prompt timely intervention to reduce the risk of stroke. The current standard for visualizing cerebral blood flow during surgery is indocyanine green angiography (ICGA), which involves administering a bolus of fluorescent dye intravenously and imaging the wash-in of the dye to determine which vessels are perfused. Unfortunately, ICGA can only be used a few times during a surgery due to the need to inject a fluorescent dye, and provides only an instantaneous view of perfusion rather than a continuous view. Laser speckle contrast imaging does not require any dyes or tissue contact and has the potential to provide complementary information to ICGA. In this study we plant to collect blood flow images with laser speckle contrast imaging and to compare the images with ICGA that is performed as part of routine care during neurovascular surgical procedures such as aneurysm clipping.

Conditions

Aneurysm, Brain, Arteriovenous Malformation of Brain, Neurovascular Disorder

Influence of MMP on Brain AVM Hemorrhage
Description

Brain vascular malformations, including arteriovenous malformations (AVM), cavernous malformations (CVM) and aneurysms, are a source of life-threatening risk of intracranial hemorrhage. The etiology and pathogenesis are unknown. There is no medical therapy presently available. Prevention of spontaneous intracerebral hemorrhage (ICH) is the primary reason to treat brain vascular malformations. The goal of this study is to: begin pilot studies to lay the groundwork for future clinical trials to develop medical therapy to decrease ICH risk. Matrix metalloproteinases (MMPs) regulate the extracellular matrix in association with various hemorrhagic brain disorders. MMP-9 has been most consistently associated with vascular wall instability and hemorrhagic brain disorders. Doxycycline, a non-specific MMP inhibitor, may enhance vascular stability, thus reducing the risk of spontaneous hemorrhage in brain vascular malformations by decreasing MMP-9 activity.

Conditions

Arteriovenous Malformations, Cavernous Angiomas, Brain Aneurysms

Safety and Feasibility of the Infinity Catheter for Radial Access
Description

The main objective of this single arm study is to evaluate the safety and feasibility of the AXS Infinity LS (Stryker, Freemont, CA, USA) and AXS Infinity LS Plus (Stryker, Freemont, CA, USA) catheters during the transradial approach through a secondary use of the data collected during neurointerventional procedures. This includes evaluating the conversion rates to a transfemoral approach. A secondary aim of the study is to assess the radial artery occlusion rates post procedure.

Conditions

Brain Tumor, Stroke, Acute, Brain Aneurysm, Intracranial Arteriovenous Malformations, Carotid Stenosis, Cavernous Sinus Thrombosis

Apollo™ Onyx™ Delivery Microcatheter Post Market Safety Study
Description

The purpose of this study is to evaluate the safety of the Apollo™ Onyx™ Delivery Microcatheter used for delivery of the Onyx™ Liquid Embolic System during brain arteriovenous malformation (AVM) embolization procedures.

Conditions

Arteriovenous Malformations

Low-dose Intra-arterial Bevacizumab for Edema and Radiation Necrosis Therapeutic Intervention (LIBERTI)
Description

To assess the overall safety and efficacy of intra-arterial (IA) bevacizumab for the treatment of radiation necrosis. A single 2.5 mg/kg dose of bevacizumab will be given intra-arterially after osmotic blood-brain-barrier disruption.

Conditions

Radiation Necrosis