Valvuloplasty Scoring Balloon Catheter First-in-Man Study
Aortic Valve StenosisThe Valvuloplasty Scoring Balloon First-in-Man study is a prospective, single arm, two phase, observational registry to demonstrate the safety and efficacy of the Valvuloplasty Scoring Balloon Catheter for the treatment of critical aortic valve stenosis.
Early Percutaneous Mitral Intervention in Asymptomatic Moderate Mitral Stenosis
Moderate Mitral StenosisAlthough percutaneous mitral commissurotomy (PMC) has been accepted as an effective treatment for symptomatic patients with moderate or severe mitral stenosis (MS), most asymptomatic patients are not candidates for PMC owing to the small but inherent procedure-related risks. Asymptomatic patients with MS show good survival rates up to 10 years, but there was a sudden deterioration precipitated by atrial fibrillation or embolism in half of the patients. Because the success rates of PMC were improved to more than 95% in ideal patients from highly selected centers and early PMC may decrease the occurrence of adverse events, such as atrial fibrillation or embolism, experienced centers tend to perform PMC at an early stage of disease. However, the potential benefits of early preemptive PMC in asymptomatic patients should be balanced against the real risks related to the procedure, and further studies of the efficacy of PMC in the prevention of embolism are necessary to extend its indications to asymptomatic patients. To the best of our knowledge, No randomized trials have been performed to ascertain the optimal timing of intervention in asymptomatic patients with significant MS. The early percutaneous MITral Intervention versus conventional manaGement in Asymptomatic moderate miTral stEnosis (MITIGATE) trial was designed to compare clinical outcomes of early intervention with those of a conventional management based on current guidelines in asymptomatic moderate mitral stenosis.
Lumbar Epidural Steroid Injections for Spinal Stenosis Multicenter Randomized, Controlled Trial...
Spinal StenosisLow Back PainThe broad, long-term objective of this research protocol is to improve the quality of life for patients suffering from lumbar spinal stenosis. This objective will be met by examining the safety and clinical efficacy of epidural steroid injections for treatment of pain associated with lumbar spinal stenosis. This prospective, randomized, double-blind controlled trial (RCT) will test the hypothesis that the effectiveness of epidural steroid injections (ESI) plus local anesthetic (LA) is greater than epidural injections of LA alone in older adults with lumbar spinal stenosis.
Progression of Carotid Artery Atheroma in Moderately Hypercholesterolemic Subjects
Carotid Artery StenosisHypercholesterolemiaThe purpose of this study is to examine the changes in the carotid artery when subjects receive high or low doses of rosuvastatin.
Study of the WallFlex™ Biliary Partially-covered Stent for the Palliative Treatment of Malignant...
Biliary Strictures Caused by Malignant NeoplasmsThis is a a prospective study of the WallFlex™ Biliary Partially-covered Stent designed to collect data to support regulatory clearance by the FDA in the United States and to determine the functionality of the WallFlex™ Biliary Partially Covered Stent as a Palliative treatment for malignant bile duct obstruction.
WallFlex Biliary Fully Covered (FC) Benign Stricture Study
Biliary StrictureThe purpose of this study is to evaluate the safety and performance of the WallFlex® Biliary RX Fully Covered Stent as a treatment of biliary obstruction resulting from benign bile duct strictures.
Comparing Carotid Stenting With Endarterectomy in Severe Asymptomatic Carotid Stenosis
Carotid StenosisPurpose of this study: Primary: • Comparison of cardiovascular mortality and morbidity which includes cardiac and neurological morbidity (TIA and CVA) in the two invasive treatments of asymptomatic carotid artery stenosis Secondary: Comparison of non cardiovascular morbidity caused by the two invasive techniques morbidity at the site of incision (infection or local hematoma) damage to cranial nerves (hypoglossus, vagus) brain hyperperfusion which is defined as severe headache which is not responsive to analgesics with or without nausea and vomiting. events of bradycardia within the first 24 hours, clinically evident and/or silent microembolic brain events immediately after the procedure and their relationship with morbidity and/or mortality due to TIA's or CVA's the change in the stenotic carotid artery at the time of follow up with duplex of neck arteries the comparison of the affect of the two procedures on patient life style
Randomized Study to Evaluate the Efficacy of Fluvastatin on Inflammatory Markers in Patients With...
Aortic Valve StenosisAtherosclerosis and aortic stenosis share inflammatory etiopathogenic characteristics in common. We hypothesized that statins therapy would decrease inflammatory markers concentrations in patients with degenerative aortic stenosis and halt the haemodynamic progression of the disease.
ViVEXX Carotid Revascularization Trial (VIVA)
Carotid Artery StenosisTo evaluate the safety and efficacy of the Bard ViVEXX Carotid Stent and Emboshield BareWire Rapid Exchange Embolic Protection System in the treatment of extracranial carotid artery stenosis in patients at high risk for carotid endarterectomy.
Paclitaxel Eluting Balloon Versus Drug Eluting Stent in Native Coronary Artery Stenoses of Diabetic...
Coronary StenosisDiabetes MellitusThe aim of the study is to compare the efficacy of Paclitaxel-eluting PTCA-balloon dilation (SeQuentTM Please) followed by cobalt-chromium stent (CoroflexTM Blue) deployment versus Paclitaxel-eluting stent (TaxusTM LibertéTM) deployment in the treatment of de-novo-stenoses in native coronary arteries (reference diameter:more then 2.5 mm and below 3.5 mm, length of stenosis ≥ 10 mm ≤ 20 mm) of patients with diabetes mellitus for ≥ 3 years for procedural success and preservation of vessel patency. This study is a prospective, randomized, multi-center, two-armed phase-II pilot study conducted in Malaysia and Thailand. 128 diabetes mellitus patients shall complete the study per protocol after random assignment to either of the treatment groups on the order of 20 to 50 patients per center. Diabetes mellitus patients with stable or selected forms of unstable angina or documented ischemia due to a de-novo stenosis in a native coronary artery will be enrolled. Vessels may not supply an entirely infarcted myocardial area. Late lumen loss at 9 months is the primary endpoint.