Active clinical trials for "Peripheral Arterial Disease"

This study is designed to evaluate the routine use of vascular ultrasound as an aid for proper placement of a femoral arterial sheath during cardiac catheterization and peripheral arterial angiography.

To investigate whether endovascular revascualrization of infrainguinal arterial obstructive disease has an effect on brachial artery reactivity

Patients with peripheral arterial disease (PAD) experience significant functional limitations due to ischemic symptoms (claudication) and are at high risk for CVD morbidity and mortality resulting from untreated cardiovascular disease (CVD) risk factors and aggressive atherosclerosis. The overall Goal of this randomized controlled clinical trial is to examine the synergistic effect of a multifactor risk reduction on walking distance, blood flow and quality of life in 300 patients with PAD. Specifically, we will compare the effects of 24 months of a novel, yet well-tested multiple risk factor reduction program, the Health Education and Risk Reduction Training (HEAR2T) Program for PAD versus enhanced standard care on: 1) symptom limited walking distance as assessed by treadmill exercise testing and walking impairment questionnaire; 2) endothelial function as measured by flow mediated vasodilation (FMVD) via brachial artery ultrasound. We will also explore the association between FMVD and decreased oxidative stress (as measured by oxygen radical absorbance capacity and urinary isoprostanes) and reduced degradation of nitric oxide (NO) and/or increased NO biosynthesis (as measured by urine nitrogen oxide, plasma nitrogen oxide, plasma asymmetric dimethylarginine, plasma, urine and platelet cyclic GMP). Secondary hypotheses examine the association between reducing CVD risk factors, improved endothelial function, increased walking distance, improved quality of life and number of metabolic syndrome abnormalities in PAD patients. Significance. This study will contribute to evidence on the efficacy of multiple risk factor reduction on improving physical function and quality of life in the understudied, elderly PAD patient. This study will also provide preliminary evidence for the biological basis for the efficacy of multifactor risk reduction in restoring vascular homeostasis, critical because of its role in antiatherogenesis and maintaining vasoreactivity, both necessary for slowing the progression of atherosclerosis.

The objective of the study is collect data on the GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface in the treatment of chronic Superficial Femoral Artery disease. Device patency at 12 months is the primary endpoint.

The Pathway PV Atherectomy System is a rotating, aspirating, expandable catheter for active removal of atherosclerotic debris and thrombus in peripheral vasculature. This is a prospective, single arm, multi-center study to obtain safety and performance data for the Pathway PV Atherectomy System when used as a primary or adjunctive therapy for percutaneous intervention to remove atherosclerotic disease, debris, and thrombus from the lower limb peripheral vasculature.

The purpose of this research study is to compare in patients with double-sided claudication if the transplant of a combination of stem cells obtained from the bone marrow of the same patient will contribute to the formation of new blood vessels in one of the severly diseased ischemic limbs(legs)versus the control limb that receives a placebo product. Limb Ischemia (LI) is a severe obstruction of the arteries which seriously decrease blood flow to the extremities (mainly feet and legs) and has progressed to the point of severe pain and even skin ulcers or sores. LI needs comprehensive treatment since the condition will not improve on its own. The overall goal of treatment is to reduce pain and increase blood flow to improve symptoms or save the leg and feet. In many cases, current options for treatment including medications, surgery or endovascular procedures have not been successful. In the last few years, investigators have explored therapies aimed to increase blood flow to the ischemic vessel by transplanting cells that will promote the development of new vessels in the diseased leg. The study hypothesis is based on the concept that the process of formation of new blood vessels is complex and requires the participation of several types of stem cells and growth factors. The lack of any of these components will produce vessels which are immature and unable to provide appropriated blood supply to the leg. Patients eligible to participate in the this study are those suffering from double-sided claudication with poor circulation or severe leg blockages, which are not candidates for surgical procedures. Once the mixture of stem cells is prepared and the patient's bone marrow is ready, cells will be transplanted into the calf muscle of one the the diseased legs while the other diseased leg will receive the placebo. Clinical study to evaluate and compare the efficacy of the stem cell transplant will be performed for six months post cell transplant.

Leg pain caused by peripheral arterial disease (PAD) can severely impede walking ability. Our preliminary findings indicate that the drug ramipril is much more effective in improving walking ability than current therapies. To be accepted as a new treatment for PAD these findings require validation in a much larger clinical trial.We propose to examine the effects of ramipril therapy for 6 months in a randomized, controlled trial of patients with PAD. If positive, this study will identify ramipril as a potential new therapy for PAD.

Diabetes is a major cause of peripheral vascular disease(PVD) and is associated with male hypogonadism. Diabetes and PVD are both associated with arterial stiffness and intima -media thickness which are also related to severity of the clinical syndrome of PVD. Artificially induced hypogonadism results in increasing arterial stiffness whilst testosterone is known to improve risk factors for vascular disease and act as a vasodilator. The purpose of this pilot study is to assess the effect of testosterone treatment on PVD arterial stiffness and intima-media thickness in men with type 2 diabetes and hypogonadism,

The objective of this study is to evaluate the safety and efficacy of the CLiRpath® Photoablation Atherectomy System consisting of the Bias Sheath guiding catheter, in combination with the available CLiRpath® Excimer Laser Catheters ≤ 2.0 mm, to create larger lumens for treatment within the superficial femoral and popliteal arteries above the knee.

The purpose of this study is to evaluate the safety and tolerability of VLTS-589 compared with placebo, administered bilaterally to the lower extremities, in subjects with intermittent claudication and to determine the effect of VLTS-589 in peak walking time (PWT) for subjects receiving VLTS-589 compared with subjects receiving placebo.