Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Symptomatic Severe...
Severe Aortic StenosisThe purpose of the study is to evaluate the safety and efficacy of the Medtronic CoreValve® System in the treatment of symptomatic severe aortic stenosis in subjects who have a predicted high risk for aortic valve surgery and/or very high risk for aortic valve surgery.
Moxy Drug Coated Balloon vs. Standard Balloon Angioplasty for the Treatment of Femoropopliteal Arteries...
Femoral Artery StenosisPopliteal Artery Stenosis2 moreThe purpose of the study is to demonstrate the superior efficacy and non-inferior safety of the Moxy Drug Coated Balloon by direct comparison to standard percutaneous transluminal angioplasty (PTA) catheter for treatment of stenosis of the femoropopliteal arteries.
PREVAIL-20J - Transfemoral Placement of 20mm Aortic Balloon Expandable Transcatheter Valve Trial...
Aortic Valve StenosisA single arm, prospective multicenter non-randomized pivotal clinical trial evaluating the 20mm Edwards SAPIEN XT™ transcatheter heart valve (model 9300TFX), NovaFlex™ transfemoral delivery system, and crimper accessories. The trial includes a premarket pivotal cohort to evaluate the system performance as well as a post market clinical follow-up phase involving long term follow-up of all patients to evaluate the safety of investigational devices up to 5 years.
Enterprise Stent Implantation in the Treatment of Carotid Artery Stenosis With Ischemic Stroke
Carotid Artery StenosisTo investigate the long-term effects of intracranial implantation of Enterprise stent system versus antiplatelet medication on neurologic deficits, daily living abilities, and carotid artery stenosis in patients with atherosclerotic ischemic stroke.
BIONICS Israel Trial
StenosisThis study aims to assess the device success and the safety of Medinol's Drug Eluting Stent - BioNIR - with a modified delivery system. The BioNIR Ridaforolimus Eluting Coronary Stent System is a single use device/drug combination product comprising: A mounted Cobalt Chromium (CoCr) alloy based stent A Rapid Exchange (RX) delivery system A polymer matrix coating - Poly n-butyl methacrylate (PBMA) and CarboSil® Ridaforolimus drug - CAS Registry Number: 572924-54-0 It is indicated for improving coronary luminal diameter in patients with symptomatic heart disease due to lesions in vessels with reference diameters of 2.5 mm to 4.25 mm, including complex lesions.
the Evaluation of Four Non-operative Treatments for Degenerative Lumbar Spinal Stenosis
Degenerative Lumbar Spinal StenosisArthritis of the spine causes narrowing of the spinal canals and compression of the spinal nerves traveling into the legs, limiting walking ability. The vast majority of individuals with arthritis of the spine are not suited for surgery and most receive non-surgical treatment. However, we do not know what non-surgical treatments are effective in improving walking in these people. The purpose of our research is to test four new treatments for arthritis of the spine to see if they can improve walking ability. Each treatment approach focuses on the changes that occur in the spine and the whole person as a result of the arthritis that directly or indirectly impacts the ability to walk and perform usual daily activities. Because arthritis of the spine is a chronic condition usually does not go away, it is important that people acquire the knowledge, skills, and tools to manage their condition on their own. The treatments that investigators plan to test as part of this research proposal are aimed at achieving this goal. However, before the investigators can promote the use of these treatments they need to formally test them using strict scientific methods to make sure they do more good than harm. The four treatments include 1) a six week training program referred to as "Boot Camp for Stenosis" which provides one-on-one training on exercise and self-management strategies 2) a patient educational workbook and video on how to self-manage, 3) an electrical device that is placed on the lower back to reduce nerve pain when walking and 4) a spinal stenosis belt that people can wear to reduce pressure on the nerves while walking. The plan is to assess the change in walking distance using the various treatments and assess what impact the treatments have on peoples' overall function and quality of life. Innovative treatment approaches with a long term perspective are urgently needed to deal with the growing number of people with arthritis of the spine who are disabled. It is likely that there is not one solution to this problem - many people will require more than one type of treatment, but an important first step is to determine which treatments are effective, then tailor the treatments to the needs of each person.
EUS - Guided Choledocho-duodenostomy Versus ERCP With Covered Metallic Stents in Patients With Unresectable...
Malignant Biliary ObstructionEUS - guided choledocho-duodenostomy (ECDS) is an established option for bile duct drainage in unresectable malignant distal CBD strictures when endoscopic retrograde cholangiopancreatography (ERCP) fails. However, how primary ECDS compares with ERCP with covered self-expanding metallic stents (CSEMS) in unresectable malignant distal CBD strictures is uncertain. The aim of the current study is to compare primary ECDS versus ERCP with CSEMS in unresectable malignant distal CBD strictures. We hypothesis that ECDS is associated with a higher 1-year stent patency rate.
Drug-eluting Balloon vs. Conventional Balloon in the Treatment of (re)Stenosis - a Randomized Prospective...
Peripheral Artery Occlusive DiseasePeripheral Artery Restenosis1 moreThe purpose of this study is to determine whether the use of drug-eluting balloons is effective in the treatment of (re)stenosis in bypass vein grafts.
Comparison of Unilateral or Bilateral Fixation in the Treatment of LFS
Lumbar Foraminal StenosisTLIF is a popular lumbar fusion technique to perform interbody fusion. Pedicle screws providing initial stability have been developed to correct deformity, improve the rate of fusion and speed patient's postoperative recovery. Conventionally, bilateral pedicle screw fixation is a standard approach. Recently, studies have revealed that unilateral pedicle screw fixation provides equivalent clinical outcomes and fusion rates as compared with bilateral pedicle screw fixation in lumbar fusion. Meanwhile, the unilateral approach can reduce intraoperative blood loss and operating time. To our knowledge, few randomized controlled studies comparing unilateral versus bilateral instrumented TLIF in lumbar degenerative diseases have been reported. The purpose of this study is to compare clinical and radiographic outcomes in a series of patients with lumbar foraminal stenosis using instrumented TLIF with unilateral or bilateral pedicle screw fixation.
Biportal Endoscopy Spine Surgery (BESS )Versus Unilateral Laminotomy Bilateral Decompression (ULBD...
Degenerative Lumbar Spinal StenosisThis study is to compare the clinical outcome between the biportal endoscopic decompression and the unilateral approach bilateral decompression in spinal stenosis