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Clinical Trials: Current Studies
STROKE Principal investigators: Demetrius K. Lopes, MD | Thomas J. Grobelny, MD The purpose of the research is to investigate Matrix 2T Detachable Coils ® (MDC) and Guglielmi Detachable Coils ® (GDC) for the treatment of aneurysms in the brain. GDC and Matrix 2T coils are medical devices that are approved in the United States by the Food and Drug Administration (FDA). An aneurysm is a bulging or ballooning out of a blood vessel caused by a weakness in the vessel's wall. An aneurysm that is located in a blood vessel in the brain is called an intracranial aneurysm. If an intracranial aneurysm is not treated, it can grow bigger, putting pressure on the brain and causing headaches or other symptoms. As it grows, it can also become so weak that it bursts, causing a stroke. Aneurysms can be treated by using small metal coils. The coils are placed into the aneurysm to block it off from the blood vessel. Over time, the coils help tissue grow that fills the aneurysm and stops the flow of blood into the aneurysm. Both devices being evaluated in the study, GDC ® and Matrix 2T coils, are similarly designed to treat an aneurysm. Matrix 2T coils are small metal coils coated with a material that helps the body grow the tissue mass that fills the aneurysm. GDC coils have no coating. The study will collect information and evaluate treatments using GDC and Matrix 2T coils. The MAPS Trial is the first study to evaluate these two treatments. The study may also help the medical community understand endpoints related to these treatments. If you meet certain requirements, you may be eligible to participate: • The patient is between 18 and 80 years of age (inclusive). • The patient has a documented untreated intracranial saccular aneurysm 4-20 mm diameter angiographic lumen, ruptured or unruptured, suitable for embolization with coils. • Both GDC ® Coils and Matrix 2T® Coils (Every attempt should be made to treat with as much randomized coil type as possible to achieve optimal occlusion) are treatment options (all shapes allowed with exception of GDC VortX Coil). • Target aneurysm can be adequately coiled at index procedure (NO staged coiling procedures). If a Neuroform stent is to be placed during a separate preliminary procedure, then screening and enrollment for the coiling procedure must take place after the stenting procedure is completed. • Target aneurysm morphology allows for adequate retention of coils within the aneurysmal sac without occlusion of the parent artery, as determined by the treating physician. • Patient (or patient's legally-authorized representative for centers in the United States) has provided written informed consent. • Patient is willing and able to comply with protocol follow-up requirements. Enrollment is ongoing. For additional information, contact Grant S. Griffin, Clinical Research Coordinator, @ 773/250.0423 or ggriffin@cinn.org.
STROKE Principal Investigator: Demetrius K. Lopes, MD | Co-Investigator: Thomas J. Grobelny, MD The NeuroformT Microdelivery Stent, a Humanitarian Use Device, may be of use in treating wide neck, intracranial aneurysms. An intracranial aneurysm is a bubble or sac on a blood vessel in the brain that can become larger over time. Aneurysms have thin, weak walls and can burst or rupture, causing bleeding into and around the brain. An intracranial aneurysm rupture can cause brain injury and death. A Humanitarian Use Device is a device used to diagnose or treat a disease or condition that affects fewer than 4,000 individuals in the United States per year and for which no comparable device is available. The United States Food and Drug Administration encourages treatment for rare conditions, so it does not require as thorough or extensive testing to demonstrate safety and effectiveness as devices intended to treat more common conditions. The FDA permits the use of Humanitarian Use Devices based primarily on evidence that the device does not pose a significant risk of injury to the patient and that the potential benefit of the device to the health of the patient outweighs the risks of its use. The NeuroformT Microdelivery Stent, for treatment of wide-necked intracranial aneurysms, meets all of the criteria of a Humanitarian Use Device and the FDA has authorized its use as a Humanitarian Use Device. In other words, the NeuroformT Microdelivery Stent, when used to treat a wide-necked, intracranial aneurysm, does not require FDA approval. It only requires that it meet the criteria the FDA has put in place for a Humanitarian Use Device. The use of the device does not involve research or data collection. The NeuroformT Microdelivery Stent can be placed in a brain artery, or a blood vessel in the brain, across the opening of an aneurysm. After the stent is in place, the aneurysm sac can be filled with small metal coils. The coils prevent blood from flowing into the aneurysm and could greatly reduce the risk of aneurysm rupture. The NeuroformT Microdelivery Stent is a small metallic mesh tube that is designed to keep the coils in the aneurysm sac. If you meet certain requirements, you may be eligible to participate: The Neuroform T Microdelivery Stent System is for use with embolic coils for the treatment of wide-neck, intracranial, saccular aneurysms arising from a parent vessel with a diameter greater than or equal to 2mm and less than or equal to 4.5mm that are not amenable to treatment with surgical clipping. Wide neck aneurysms are defined as having a neck greater than or equal to 4mm or a dome-to-neck ratio of less than 2. Enrollment is ongoing. For additional information, contact Michelle Catalano, Clinical Research Coordinator, @ 773/250.0422 or mcatalano@cinn.org. STROKE Principal Investigator: Thomas J. Grobelny, MD | Co-Investigator: Demetrius K. Lopes, MD The SAPPHIRE WW Registry is a multi-center clinical research study that will evaluate the effects of a system using two new investigational devices to treat carotid artery disease. Carotid artery disease is a blockage or hardening in one or more of the blood vessels in the neck. The carotid artery supplies blood to the head and brain. If the blood supply to the brain is blocked or reduced, it may result in weakness, pain, or difficulties with speech, hearing or vision. It may also result in stroke, a condition resulting from a lack of oxygen in the brain. It is often caused by interrupted blood flow or coma, a prolonged loss of consciousness. Increasing the blood flow by enlarging the blood vessel at the point of narrowing or blockage may lessen or reverse symptoms associated with the reduced blood flow. The investigational system being studied includes two investigational devices. The first device is called the Cordis PRECISE â Nitinol Stent System. The stent is permanently placed inside the carotid artery and can only be removed by a surgical procedure, although it is highly unlikely that such a procedure would be necessary. The stent is placed at the part of the artery that is narrowed or blocked, and it expands after it is placed in the artery. When the stent expands, it is meant to keep the carotid blood vessel open, which allows more blood to flow through it to the brain. The device is approved by the United States Food and Drug Administration (FDA). Other PRECISE â stents may be used once they are approved by the FDA. The second investigational device is called the Cordis ANGIOGUARD ä XP/RX Emboli Capture guidewire (ECGW). The ECGW is used for protection during the placement of the PRECISE â Nitinol Stent System. The ECGW is a tiny filter basket at the end of the Guidewire in the shape of an umbrella. When the device is opened, it acts as a filter or strainer, allowing blood to flow through it while at the same time collecting any particles, such as pieces of the blockage, that may be dislodged or break off from the lesion during the procedure. After the stent is placed and expanded in the blood vessel, the filter is closed and removed from the vessel. This device is also approved by the FDA for use during the treatment of carotid artery disease. If you meet certain requirements, you may be eligible to participate: • High surgical risk patient • Patient or legally authorized representative has signed written informed consent and HIPPA authorization Enrollment is ongoing. For additional information, contact Grant S. Griffin, Clinical Research Coordinator, @ 773/250.0423 or ggriffin@cinn.org. STROKE Principal Investigator: Demetrius K. Lopes, MD | Co-Investigator: Thomas J. Grobelny, MD The CORDIS ENTERPRISET Vascular Recontstructive Device (VRD) and Delivery System (DS) meets all of the criteria of a Humanitarian Use Device, and the United States Food and Drug Administration has authorized its use as a Humanitarian Use Device for treatment of wide-necked, intracranial, saccular or fusiform aneurysms. An intracranial aneurysm is a bubble or sac on a blood vessel in the brain that can become larger over time. Aneurysms have thin, weak walls and can burst or rupture causing bleeding into and around your brain. An intracranial aneurysm rupture can cause brain injury and death. A Humanitarian Use Device is a device used to diagnose or treat a disease or condition that affects fewer than 4,000 individuals in the United States per year and for which no comparable device is available. The FDA encourages treatment for rare conditions, so it permits the use of a device it designates as a Humanitarian Use Device. Its permission is based primarily on evidence that the device does not pose a significant risk of injury to the patient, and that the potential benefit of the device to the health of the patient outweighs the risks of its use. The FDA does not require as thorough or as extensive of testing in order to demonstrate the safety and effectiveness of a Humanitarian Use Device as compared to the requirements of devices intended to treat more common conditions. The CORDIS ENTERPRISET VRD and DS can be placed in a brain artery, or vessel in the brain, and across the neck, or opening, of an aneurysm. After the stent is in place, the aneurysm sac can be filled with small metal coils. The coils prevent blood from flowing into the aneurysm and could greatly reduce the risk of aneurysm rupture. The use of the device does not involve research or data collection. If you meet certain requirements, you may be eligible to participate: This device is intended for use with embolic coils for the treatment of wide-neck, intracranial, saccular or fusiform aneurysms arising from a parent vessel with a diameter of greater than or equal to 3mm and less than or equal to 4mm. Wide-neck is defined as having a neck width greater than or equal to 4 mm or a dome-to-neck ratio of less than 2. Enrollment is ongoing. For additional information, contact Grant S. Griffin, Clinical Research Coordinator, @ 773/250.0423 or ggriffin@cinn.org. STROKE Principal Investigator: Demetrius K. Lopes, MD | Co-Investigator: Thomas J. Grobelny, MD The WingspanT Stent System with GatewayT PTA Balloon Catheter is a Humanitarian Use Device that may be of use in treating intracranial atherosclerotic disease, or a narrowing or hardening of the blood vessels in the head. The use of the device does not involve research or data collection. The WingspanT Stent System with GatewayT PTA Balloon Catheter consists of a Wingspan Stent, a Wingspan Delivery System, and a Gateway PTA Balloon Catheter. A Humanitarian Use Device is a device used to diagnose or treat a disease or condition that affects very few individuals in the United States per year and for which no comparable device is available. The United States Food and Drug Administration (FDA) encourages treatment for rare conditions, so the FDA does not require as thorough testing to demonstrate the safety and effectiveness of Humanitarian Use Devices as it does for devices intended to treat more common conditions. The FDA permits the use of Humanitarian Use Devices based primarily on evidence that the device does not pose a significant risk of injury to the patient and that the potential benefit of the device to the health of the patient outweighs the risks of its use. In other words, the WingspanT Stent System with GatewayT PTA Balloon Catheter does not require FDA approval when used to treat intracranial atherosclerotic disease. The WingspanT Stent System with GatewayT PTA Balloon Catheter, for treatment of intracranial atherosclerotic disease, meets all of the criteria of a Humanitarian Use Device and the FDA has authorized its use as a Humanitarian Use Device. If you meet certain requirements, you may be eligible to participate: The WingspanT Stent System with GatewayT PTA Balloon Catheter is indicated for improving cerebral artery lumen diameter in patients with intracranial atherosclerotic disease, refractory to medical therapy, in intracranial vessels with greater than or equal to 50% stenosis that are accessible to the system.
Enrollment is ongoing. For additional information, contact Michelle Catalano, Clinical Research Coordinator, @ 773/250.0422 or mcatalano@cinn.org. BRAIN Principal Investigator: Gail L. Rosseau, MD Co-Investigators: Claudia Tellez, MD | Thomas J. Grobelny, MD Breast cancer is the most common cancer and the second leading cause of cancer death in women. Death is sometimes caused by to the spread of breast cancer to other body systems or metastatic breast cancer (MBC). An increasingly frequent cause of death in patients with MBC is brain metastasis, or cancer in the brain. The Early Detection of Brain Metastases From Advanced Breast Cancer Through Education and Screening is being done to look at the potential value of routine brain imaging in the detection of brain metastases in subjects with advanced breast cancer. It is hoped that information will help doctors in the early detection of brain metastases. The study is also being done to increase awareness about brain metastases in breast cancer patients and the potential benefits of early detection and treatment options available. Participants in the study must have previously been diagnosed with advanced breast cancer. For the study, advanced breast cancer includes HER-2 positive Stage III or Stage IV breast cancer. Stage III breast cancer is breast cancer that has spread to 4 or more lymph nodes in the armpit, or has spread to the chest wall, skin, or to lymph nodes near the breastbone or collarbone. HER-2 stands for human epidermal growth factor receptor 2. HER-2 helps control how cells grow, divide and repair themselves. Each healthy breast cell contains 2 copies of HER-2, which helps normal cells grow. Sometimes a cell may have too many copies of HER-2. Breast cancer that has too much HER-2 is referred to as HER-2 positive. Stage IV breast cancer is breast cancer that has spread outside of the breast to bones, lungs, brain or other distant lymph nodes or organs in the body, also called metastatic breast cancer, or MBC. If you meet certain requirements, you may be eligible to participate: A. Subjects must have an initial primary diagnosis of high-risk and/or HER-2 positive breast cancer. For purposes of this screening study, high-risk breast cancer at initial diagnosis is defined as: » Stage IV disease, or » HER-2 positive Stage III disease B. Subjects must be > = 18 years old. C. Subjects must be within three to twenty-four months of first metastases or Stage IV diagnosis or within 12 to 24 months of initial diagnosis of HER-2 positive Stage III disease. D. Subjects must sign a written³ informed consent form approved by the Institutional Review Board (IRB). Enrollment is ongoing. For additional information, contact Sandra Davis, Vice President of Endovascular Services and Research, @ 773/250.0423 or sdavis@cinn.org.
BRAIN Principal Investigator: Gail L. Rosseau, MD Co-Investigators: Charles Wang, MD The purpose of the Normal Pressure Hydrocephalus (NPH) Registry is to use an electronic database to collect data on different treatments of patients with NPH and the outcomes, or results, of these treatments. The research involves collecting medical and health information for a data registry. It is hoped that the information will help doctors learn to improve the way in which patients are treated for NPH. If you meet certain requirements, you may be eligible to participate: • Meet diagnosis criteria for NPH • Candidate for hydrocephalus shunt system • Patient or legally-authorized representative signs informed consent form Enrollment is ongoing. For additional information, contact Grant S. Griffin, Clinical Research Coordinator, @ 773/250.0423 or ggriffin@cinn.org. SPINE Principal Investigator: Noam Y. Stadlan, M.D. Co-Investigators: Dean G. Karahalios, M.D. | Edward H. Mkrdichian, M.D. The purpose of the study is to evaluate the effectiveness, safety, and performance of DuraGen Plus ® Adhesion Barrier Matrix, a device intended to prevent or minimize adhesions or scars that may develop after operations on the spine. Adhesions and scars that form on organs after surgery are common and may be responsible for chronic pain and limited movement. Adhesions are fibrous structures that connect tissues or organ surfaces that are not normally joined. Adhesion formation is an undesirable side effect of the body's normal healing processes following tissue injury. The DuraGen Plus ® Adhesion Barrier Matrix has already been cleared for marketing by the United States Food and Drug Administrations (FDA) as a dural substitute for the repair of the dura mater, a protective lining of the brain and spinal cord. The study will specifically evaluate the use of DuraGen Plus to minimize adhesions and scars after lumbar discectomy, a surgery to repair a ruptured or slipped disk in the back. If you meet certain requirements, you may be eligible to participate: • Are > or =18 and < or =70 years of age • Patients with radicular pain requiring single-level, elective lumbar hemilaminectomy or hemi-laminotomy procedures with discectomy in the area between L4 and S1 • Require initial open lumbar surgery, for extruded, prolapsed or bulging intervertebral discs • Require removal of herniated disc fragment • Are willing and able to comply with the study protocol • Are medically cleared for surgery • Have given written informed consent to participate in the study • Have a baseline MRI that has been rated acceptable Enrollment is ongoing. For additional information, contact Michelle Catalano, Clinical Research Coordinator, @ 773/250.0422 or mcatalano@cinn.org. sPINE Principal investigator: Dean G. Karahalios, MD Co-Investigators: Leonard J. Cerullo, MD | Demetrius K. Lopes, MD | Gail L. Rosseau, MD | Edward H. Mkrdichian, MD The purpose of the research is to study a new device, known as the Spinal Sealant System. The study will investigate whether or not use of the Spinal Sealant System is better than standard methods used to seal the dura to stop cerebrospinal fluid, or CSF, from leaking during spinal surgery. The lining that covers your brain and spinal cord is called the dura, which holds in CSF. CSF provides a liquid cushion for the brain and spinal cord. In order to perform surgery, a doctor makes an opening in the dura. At the end of the surgery, the dura must be closed in order to stop CSF from leaking out of the opening. A doctor closes the opening in the dura with stitches. He or she may also use a piece of muscle or fat, or other soft tissue taken from another place on your body to help close the hole and prevent a CSF leak. The Spinal Sealant is made of two liquids. When mixed, the liquids form a gel that is mostly made up of water. The gel looks and feels somewhat like a soft contact lens. After the doctor closes the opening in the dura with stitches, the gel is applied over the stitches. It acts as a thin, stretchy film meant to stop CSF from leaking through the stitches until the area heals on its own. The gel is blue so the doctor can see where it has been applied. The body naturally breaks down the gel one to two months after it is applied. It is removed through urine. The gel is currently used in brain surgery. The Spinal Sealant System study will test its use in spinal surgery. If you meet certain requirements, you may be eligible to participate: Pre-Operative Inclusion Criteria: • Patient is between 18 and 75 years of age • Patients scheduled for a spinal procedure that requires a dural incision • Patient requires a procedure involving surgical wound classification Class I/Clean (per CDC criteria) • Patient or authorized representative has been informed of the nature of the study and has provided written informed consent approved by the appropriate Institutional Review Board (IRB) of the respective clinical site Intra-Operative Inclusion Criteria: • Presence of non-watertight closure, either spontaneously or upon Valsalva maneuver, to 20-25 cm H 2 0 for 5-10 seconds Enrollment is ongoing. For additional information, contact Michelle Catalano, Clinical Research Coordinator, @ 773/250.0422 or mcatalano@cinn.org. sPINE Principal Investigator: Noam Y. Stadlan, MD Co-Investigators: Dean Karahalios, MD | Kenneth Heiferman, MD | Kevin Koutsky, MD The Total Facet Arthroplasty System, or TFAST is being investigated to determine its safety and effectiveness for treating patients with lower back problems. TFAST and the surgical instruments used to insert the device are the experimental part of the study. Lumbar spinal stenosis is a narrowing of the space surrounding the spinal cord in the lower back and/or the nerve roots, that is, the nerves going from the spinal cord into the buttocks and legs. The narrowing may be caused by arthritis, the swelling of a joint, or by an overgrowth of bone on the vertebra, which are the bones of the spine. Narrowing puts pressure on nerves and causes uncomfortable lower back, buttock, and/or leg symptoms. Patients may benefit from a surgical procedure to remove bony pieces called facets and laminae from the back of one of the lumbar vertebra. The device being used in the study is meant to replace the bone that is removed from the vertebra so that patients are able to maintain movement and stability at the same particular level of the spine. If you meet certain requirements, you may be eligible to participate: • Degenerative spinal stenosis, central or lateral, at spinal levels L3-L4 or L4-L5, with radiographic confirmation of any one of the following by CT, MRI, plain film or myelography: • Evidence of thecal sac and/or cauda equina compression; • Evidence of nerve root impingement by either osseous or non-osseous elements; • Evidence of hypertrophic facets with encroachment into the central canal or lateral recess. • No greater than Grade I degenerative spondylolisthesis at the index level; • Intermittent neurogenic claudication, indicated by the presence of persistent leg symptoms, marked by posterior or anterior thigh or calf discomfort, pain, numbness, parasthesia, weakness, tiredness or heaviness, buttock or lower back symptoms including pain, numbness, burning or tingling, that is aggravated by walking and/or standing and is relieved only after resting in a flexed lumbar spine position; • Skeletally mature male or female between the ages of 50 and 85 years of age inclusive; • Operative candidates with no more than three levels of degenerative lumbar spinal stenosis requiring decompression; (Note: Up to three contiguous levels of decompression is allowed, however, only one level is eligible for instrumentation with the TFAST system or Control) • Pre-operative "Patient Symptom" score equal to or greater than 15 out of a total possible 35 on Form 4 Patient Symptoms and Function Questionnaire; • Pre-operative "Patient Function" score equal to or greater than 10 out of a total possible 20 on Form 4 Patient Symptoms and Function Questionnaire; • Willing and able to sign the Informed Consent document; • Experienced symptoms of intermittent neurogenic claudication and/or functional deficit for a minimum duration of six months; • Failed to respond to non-operative treatment modalities for a minimum duration of six months. Enrollment is ongoing. For additional information, contact Michelle Catalano, Clinical Research Coordinator, @ 773/250.0422 or mcatalano@cinn.org. |
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