Active clinical trials for "Peripheral Vascular Diseases"

The aim of this study is to prospectively collect information to evaluate the safety and performance of the Akesys Prava Sirolimus Eluting Bioresorbable Peripheral scaffold system for the treatment of symptomatic primary atherosclerotic stenoses and occlusions of the superficial femoral artery (SFA).

This is a prospective, multi-center, single-arm, non-blinded study designed to investigate the safety and efficacy of the Tack Endovascular System in the Mid/Distal Popliteal, Tibial, and Peroneal Arteries ranging in diameter from 1.5mm to 4.5mm for the treatment of post percutaneous transluminal balloon angioplasty (PTA) dissection(s) requiring repair.

Peripheral arterial disease (PAD) is characterized by lower limb arterial obstruction due to atherosclerosis. Magnetic resonance imaging (MRI) methods can accurately quantify atherosclerotic plaque in the superficial femoral artery (SFA) in patients with PAD. Such techniques have demonstrated plaque regression with statin therapy over 1 year. Alirocumab is a PCSK9 inhibitor that effectively reduces LDL cholesterol up to 70% in patients on statins or intolerant to statins. The investigators hypothesize that effective low density lipoprotein (LDL) lowering with Alirocumab 150m subcutaneously (SQ) every 2 weeks will regress atherosclerotic plaque in the SFA in patients with PAD over one year compared to placebo. 54 patients with mild-moderate PAD (ankle brachial index or ABI 0.4-0.9) will be randomized to alirocumab 150 mg SQ every 2 weeks or matching placebo at the University of Virginia (UVA) (n=34) and Northwestern (n=20). The primary endpoint is change in atherosclerotic plaque volume in the superficial femoral artery over the 1 year treatment period. Secondary endpoints include changes in peak calf muscle perfusion after thigh cuff occlusion/hyperemia, 6-minute walk distance, and blood biomarkers (LDL cholesterol, fibrinogen, high sensitivity c-reactive protein (hs-CRP), and lipoprotein(a).

The prevalence of peripheral arterial disease (PAD) is greater than 15%. PAD is associated with an increased risk of cardiovascular death, coronary heart disease and stroke, with a mortality rate of 5% per year. Most clinical evidence supports the idea that having normal vitamin D reduces cardiovascular risk. The data suggests that normalizing vitamin D levels would have a significant impact on public health, reduce costs and help control the incidence and prevalence of cardiovascular disease. There is also a plausible physiological theory, supported by numerous observational studies, that vitamin D supplementation should be effective in improving cardiovascular outcomes, such as blood pressure, arterial stiffness, atherosclerosis, endothelial function, and clinical events. The investigators hypothesize that routine screening for vitamin D deficiency and supplementation in case of hypovitaminosis D is effective for improving the maximum walking distance after 12 weeks of treatment in stage 2 PAD patients .

The VMI-CFA study investigates the efficacy of the Supera Stent in the treatment of common femoral artery stenosis or occlusion. 100 patients will be included with a RF of 2 to 4. The lesion is located within the native CFA and treated with predillation prior to stenting with the Supera Peripheral Stent System. Patients will be invited for a follow-up visit at 1, 6, 12 and 24 month post procedure. The primary endpoint of the study is the primary patency at 12 months and periprocedural events up to 30 days post procedure. Secondary endpoints include technical success, primary patency rate at 1, 6 and 24 month, freedom from TLR at 1-, 6-, 12 and 24 month follow-up and clinical success at 1-, 6-, 12- and 24-month follow-up.

Prospective, multi-center, single-arm study of the M5+ Peripheral IVL system to treat calcified peripheral arteries.

This study aims to evaluate whether remote ischemic preconditioning (RIPC) daily for 28 days reduces the symptoms of intermittent claudication in patients with peripheral artery disease (PAD). The study evaluates the effect of RIPC on patients' total walking distance (TWC), initial claudication distance (ICD), and time to relief of claudication (TRC). In addition, the trial investigates the effect of RIPC on different arterial functional characteristics and low molecular weight metabolites in serum and affected skeletal muscle.

The hypothesis is that oral supplementation of L-carnosine will inhibit PHDs, increase HIF1-translocation and angiogenesis and thus improve the functioning of lower extremities in PAD patients. Primary Aim: 1. Compare the effect of carnosine and placebo supplementation on the 6MWT in PAD patients with and without claudication. Secondary Aim: Determine whether carnosine supplementation improves the pain-free treadmill walking ability of the subjects supplemented with carnosine compared to placebo. Compare the levels of carnosine, VEGF, HIF-1α, and PHDs activity in the skeletal muscle before and after placebo and carnosine supplementation. Compare the levels of EPCs (CD34+/CD133+), inflammatory markers (serum amyloid A, hsCRP) and thrombotic markers (fibrinogen, homocysteine) as cardiovascular risk markers in these subjects. Explore the effects of race and gender on VEG, carnosine, and HIF-1α levels in both groups.

LEGDEB2 is a Global Registry for the Treatment of Superficial Femoral and/or Popliteal or Below-The-Knee or Iliac Artery Lesions Using the Legflow Drug-Eluting Balloon

The objective of this clinical evaluation is to evaluate the immediate and long term (up to 12 months) outcome of the XIENCE PRIME Everolimus Eluting Coronary Stent System (Abbott Vascular) in a controlled prospective investigation for the treatment of patients with critical limb ischemia due to the presence of lesions between 3cm and 10cm in length at the level of the below the knee arteries. Specifically the trial aims to illicit angiographic and ultrasound patency, clinical improvement, and adverse events associated with the use of this stent. The trial design is single armed, prospective, controlled trial run over 12 months of follow-up.