An Investigation of the TReatment of FecAL IncontiNence using the TOPAS Sling System FOR WoMen (TRANSFORM)
Study Timeline: Currently enrolling
The TRANSFORM study is being conducted to determine the effectiveness of an investigational device in reducing episodes of fecal incontinence. This study uses the TOPAS
TM Sling System which is an investigational device from American Medical Systems (AMS). The TOPAS
TM Sling System is a small piece of mesh placed behind the anus through small incisions during a minimally invasive surgical procedure. The mesh creates a sling to give extra support to muscle that has been damaged or weakened
ASD2 (Atrial Spetal Defect) PMS
Study Timeline: Currently Enrolling
The purpose of this study is to gather more information about how effective the Amplatzer Septal Occluder is at closing an atrial septal defect. Atrial septal defect (ASD) is a congenital (occurring at birth) heart defect in which the wall that separates the upper heart chambers (atria) does not close completely. The study is also being done to collect information about the safety of the device. The study is being conducted at up to 30 medical centers across the United States.
ATLAS WORKHORSE: A multi-center, single-arm study of the TAXUS Liberte'-SR stent for the treatment of patients with de novo coronary artery lesions
Study Timeline: Closed to enrollment
This study examines the safety and effectiveness of the TAXUS Liberte'-SR stent in patients with symptomatic heart disease. After determination of eligibility including coronary angiography, all participants will receive the Liberte'-SR drug-eluting stent coated with paclitaxel. Only one heart artery may be treated with the study stent. Participants will be followed for 5 years.
ATTRACT : Acute Venous Thrombosis: Thrombosis Removal With Adjunctive Catheter-Directed Thrombolysis
Study Timeline: Currently Enrolling
This study is designed to test standard treatment for blood clots with standard treatments and a new treatment. All participants will receive blood-thinning drugs, the standard treatment for blood clots. In addition half of the study participants will be randomly chosen to have their clot dissolved using a clot-busting drug (TPA) that a doctor will inject directly into the clotted vein through a specially designed drug delivery catheter.
Participants are followed for 2 years to assess possible symptoms related to the clot and how well both treatments prevent complications.
BENEFIT and BENEFIT EXT
Study Timeline: Closed to enrollment
Belatacept Evaluation of Nephroprotection and Efficacy as First-Line Imunosuppression Trial (BENEFIT)
These studies are designed for adults who receive a kidney transplant. They are planned to compare standard anti-rejection medicine to an experimental anti-rejection medicine, Belatacept. Both will look carefully at how well the anti-rejection medicine works and how it may be potentially less harmful to the transplanted kidney. Participants will be randomly assigned to receive standard medicine (cyclosporine) or the experimental medicine (Belatacept).
BENEFIT EXT is similar to the BENEFIT study except that the donor kidney must meet special criteria. The intent is to show improved graft function for participants receiving a kidney transplant with organs that meet these expanded criteria.
BioSeal-Lung Biopsy Tract Plug Study
Study Timeline: Currently enrolling through Oct 2007
This is a randomized study. Participants will receive either a standard of care lung biopsy procedure or an experimental lung biopsy with the placement of an absorbable plug in the biopsy needle tract.
CLEVER: Claudication: Exercise vs Endoluminal Revascularization
Study Timeline: Currently enrolling
This study is a randomized, multi-center clinical trial designed to determine optimal treatment for individuals with intermittent claudication from peripheral arterial disease (PAD). This study is the only study of its kind to compare medical therapy, supervised exercise training and invasive catheterization/stent revascularization procedures
CLOSURE I :
Study Timeline: Currently open to enrollment
CLOSURE I - Is a Prospective, Multicenter, Randomized Controlled Trial to Evaluate the Safety and Efficacy of the Starflex Septal Closure System versus Best Medical therapy in Patients with a Stroke and/or Transient Ischemic Attach due to Presumed Paradoxical Embolism Through a Patent Foramen Ovale.
There are two objectives for this study. First, to learn if the study device, when placed in the heart, will safely and effectively prevent a recurrent embolic stroke or TIA (transient ischemic attack) in patients with a patent foramen ovale (PFO). Second, to compare the study device to the best medical therapy. Best medical therapy is the use of aspirin, Coumadin, or a combination of both.
If all eligibility criteria are met, patients are randomized to study device placement or best medical therapy. Clinical follow-up for all patients is at 1, 6, 12 and 24 months post-enrollment.
CORAL : Cardiovascular Outcomes in Renal Atherosclerosis (CORAL)
Study Timeline: Closed to Enrollment
This study is designed for individuals with hypertension and renal stenosis (narrowing of the arteries in the kidney). Participants are assigned to one of two treatment groups. Both groups receive optimal medical therapy for their renal disease, either with or without renal stenting. (Renal stenting is a medical procedure inserting a wire mesh tube into the artery to keep it open.)
COSTAR CObalt chromium STent with Antiproliferative for Restenosis II Trial (The COSTAR II Trial)
Study Timeline: Closed to enrollment
This study examines the safety and effectiveness of two different drug-eluting stents (CoStar(R) and TAXUSTM) in patients with symptomatic heart disease. Participants will have blockage(s) in one, two or three of their heart or coronary arteries as determined by angiography. They will be randomized to receive either the TAXUS stent (coated with paclitaxel) or the CoStar stent (paclitaxel loaded into reservoirs located within the stent struts). Participants in the trial will be followed for a period of 5 years.
CREST
Study Timeline: Closed to enrollment
This study is designed to compare two treatments for carotid artery stenosis in low-risk patients. Participants are assigned randomly to receive either carotid surgery (standard treatment) or carotid stenting.
ENDEAVOR III: A Randomized Controlled Trial of the Medtronic Endeavor Drug (ABT-578) Eluting Coronary Stent System versus the Cypher Sirolimus-Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions
Study Timeline: Closed to enrollment
This study examines the safety and effectiveness of two different drug-eluting stents (ENDEAVOR and CYPHER stents) in patients with symptomatic heart disease. Participants will have single, untreated blockage(s) in one of their heart arteries as determined by coronary angiography. They will be randomized to receive either the ENDEAVOR stent (coated with ABT-578) or the CYPHER stent (coated with sirolimus). Participants will be followed for 5 years.
Gore REVISE (GORE VIABAHN® Endoprosthesis versus Percutaneous Transluminal Angioplasty (PTA) to Revise Arteriovenous Grafts at the Venous Anastomosis in Hemodialysis Patients)
Study Timeline: Currently Enrolling
The Gore REVISE study is a randomized study. It has been designed to establish the effectiveness and safety of the GORE VIABAHN® Endoprosthesis (stent) with PROPATEN Bioactive Surface in prosthetic hemodialysis grafts. This specialized graft will be used to treat narrowing at the venous end of the graft in order to maintain or re-establish the vascular access for hemodialysis. The goal of the study is to track the natural course of the vascular access as the Subject undergoes regular hemodialysis at their respective dialysis center. Participants will be followed at 1, 3, 6, 12, 18, and 24 - months post-procedure to assess the safety and effectiveness of the treatment.
HeartMate II Left Ventricular Assist Device as Destination Therapy (Permanent Implant)
Study Timeline: Currently enrolling
Patients who are not candidates for heart transplant owing to age or other diseases and have been treated with all medical management available and are still in danger of dying are implanted with this axial flow pump. The patient is randomized to the study device or the only approved device for DT, the HeartMate XVE LVAD. The device is designed to support their heart for years. The patient will be followed for the rest of his life.
IRIS
Study Timeline: Currently open to enrollment
This study is designed to compare the study medication (pioglitazone) vs. a placebo for prevention of stroke and myocardial infarction (heart attack) in individuals who have recently had either an ischemic stroke or a transient ischemic attack.
PIVOTAL: Positive Impact of Endovascular Options for Treating Aneurysms Early
Study Timeline: Closed to enrollment
This study compares Endovascular stent repair versus standard surveillance of patients with small abdominal aortic aneurysms
SAMIS Trial
Study Timeline: Currently enrolling
This study is designed to compare two medications used to treat a heart rhythm disorder called "Superventricular Tachycardia", or SVT, in infants. Both of theses medications, Digoxin and propranolol, are currently used to treat SVT. This study is being done to evaluate if either of the medications is better at treating SVT.
SAMMPRIS
Study Timeline: Currently enrolling
The SAMMPRIS trial is being done to determine whether intracranial stenting (a device inserted in a blood vessel in the brain) combined with intensive medical therapy is better than intensive medical therapy alone for preventing stroke or death in individuals who have had a stroke or TIA (mini stroke) caused by a narrowing in one of the arteries in the brain.
SCAN (Short Cervix and Nulliparas)
Study Timeline: Currently enrolling
This study is being done to determine if giving progesterone who have a short cervix will lower the risk of early delivery in women who are having their first baby. Participation requires a screening ultrasound provided at no-cost.
SHARP: Study of Heart and Renal Protection
Study Timeline: Closed to enrollment
The purpose of this study is to test whether reducing cholesterol can prevent heart disease and strokes in patients with Chronic Kidney Disease.
