Standard Versus PICO Dressings in Lower-Extremity Bypass Patients
Of Bypass Graft of the ExtremitiesPeripheral Arterial Disease2 moreThe objective of this study is to compare the effectiveness of standard moist dressings and PICO single-use negative pressure dressings in post-operative lower extremity bypass patients. This study will compare the dressings' ability to decrease swelling, decrease post-operative infection, and improve mobility and quality of life measures. Subjects will be asked to participate in this study because they will undergo a lower extremity bypass using the ipsilateral great saphenous vein. Subjects will then be randomized to two post-operative treatment groups. One group will receive standard sterile gauze and the other will receive PICO single-use negative pressure dressings. Both groups will be assessed for study measures in follow-up visits as clinically indicated up to 1 year with the 30 day timepoint as the primary outcome for study measures.
Comparison of the SUpera® PERipheral System in the Superficial Femoral Artery
Peripheral Vascular DiseaseThis is a prospective, multicenter, non-randomized, single arm, pivotal trial. The main objective of this study is to demonstrate the safety and effectiveness of the IDev SUPERA® Nitinol Stent System in treating subjects with obstructive superficial femoral artery (SFA) disease. The primary endpoint will be the primary patency of the SFA evaluated at 12 months. The outcome will be compared to a performance goal based on clinical trials of percutaneous transvenous angioplasty (PTA) alone.
Bosentan for Mild Pulmonary Vascular Disease in Asd Patients.
Heart Septal DefectsAtrialVolume overload due to left-to-right shunting in patients with atrial septal defect type secundum causes pulmonary vascular disease over a long period of time. Pulmonary vascular resistance can be assessed non-invasively using bicycle stress echocardiography. By measuring cardiac output and pulmonary artery pressures at different stages of exercise, a pressure-output plot can be obtained. The slope of the pressure-output plot reflects pulmonary vascular resistance. In patients undergoing ASD repair after the age of 40 years, pulmonary vascular resistance was higher when compared to age-matched controls, indicating the presence of mild pulmonary vascular disease. Bosentan has been shown to decrease pulmonary vascular resistance. The investigators hypothesize that in patients with an ASD type secundum, who underwent ASD repair after the age of 40 years, administration of bosentan decreases pulmonary vascular resistance as assessed by bicycle stress echocardiography.
Bard® LifeStent® Vascular Stent Delivery System Study
Peripheral Vascular DiseaseThe purpose of this study is to evaluate the effectiveness and safety of a new delivery system for the Bard® LifeStent® Vascular Stent System.
Study to Compare 2 Doses of Polycap Versus Single Dose of Polycap With or Without Pottasium
Ischemic Heart DiseaseIschemic Stroke2 moreThis is a randomized double blind 2x2 factorial controlled trial to evaluate efficacy tolerability of low strength Polycap versus two doses of low strength Polycap in patients with stable cardiovascular disease in reducing blood pressure and LDL. To evaluate the tolerability and safety of low dose potassium supplementation compared to placebo in patients with stable cardiovascular disease. Approximately 500 patients are planned to be randomized.
A Clinical Evaluation of the XIENCE PRIME Small Vessel Everolimus Eluting Coronary Stent System...
Vascular DiseaseMyocardial Ischemia4 moreThe purpose of this study is to evaluate the safety and effectiveness of the AVJ-09-385 Small Vessel Everolimus Eluting Coronary Stent System (EECSS) (2.25 mm diameter stent) in treatment of subjects with ischemic heart disease caused by de novo lesions.
GORE VIABAHN® Versus Plain Old Balloon Angioplasty (POBA) for Superficial Femoral Artery (SFA) In-Stent...
Peripheral Vascular DiseaseThis is a prospective, randomized, multi-center study recruiting patients with an in-stent restenosis in the superficial femoral artery. The safety and efficacity of the Viabahn endoprosthesis (W.L. Gore & Associates), a heparin-bonded endoprosthesis, is compared with plain old balloon angioplasty (POBA). In 4 Belgian and 2 German centers a total of 80 Patients will be recruited. Primary endpoint is primary patency at 12 months, defined as no evidence of restenosis or occlusion within the originally treated lesion based on color-flow duplex ultrasound (CFDU) measuring a peak systolic velocity ratio ≤2.5, and without target lesion revascularization (TLR) within 12 months. In comparison to POBA, it is expected that the use of the Viabahn endoprosthesis (W.L. Gore & Associates) will result in greater 12 month primary patency of treated superficial femoral artery in-stent restenotic lesions.
Safety Study of 2.0mg Lucentis to Treat Polypoidal Choroidal Vasculopathy
Polypoidal Choroidal VasculopathyThis Phase I/II study will investigate the safety and tolerability of intravitreally administered 0.5mg and 1.0 or 2.0mg Ranibizumab in three monthly doses followed by a 9 month period of criteria-based, as-needed retreatment and 12 month of drug safety follow up in subjects with exudative polypoidal choroidal vasculopathy (PCV) for a total of 24 months.
Efficacy and Safety of Verteporfin Added to Ranibizumab in the Treatment of Symptomatic Macular...
Polypoidal Choroidal VasculopathyThis study aims to compare the efficacy of ranibizumab and verteporfin PDT combination treatment and verteporfin PDT monotherapy vs.ranibizumab monotherapy alone in achieving complete regression of polyps in patients with symptomatic macular polypoidal choroidal vasculopathy.
The Complete® SE SFA Study for the Treatment of SFA/PPA Lesions
Peripheral Vascular DiseaseTo evaluate the safety and efficacy of the Complete SE SFA Stent System in the treatment of de novo and/or restenotic lesions or occlusions in the Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA) in subjects with symptomatic Peripheral Artery Disease (PAD).