View clinical trials related to Peripheral Arterial Disease.
Filter by:Background. Arterial dissections represent the typical complication of the percutaneous transluminal angioplasty for femoropopliteal disease and have negative impact upon the outcomes of the treatment. Objective. The study is aimed to test the hypothesis that a prolonged (6 minutes) time of inflation of angioplasty balloon would reduce the rate of severe arterial dissections and necessity in bailout stenting during the treatment of occlusive-stenotic femoropopliteal lesions in patients with chronic limb threatening ischemia. Methods. The LOVES trial is a single centre, two parallel groups, controlled trial with 1:1 randomization. Participants will be recruited among the patients hospitalized in Vascular Surgery Department of Institute of Emergency Medicine, Chisinau, Republic of Moldova. Procedure. Diagnostic angiography of the treated limb will be performed first to confirm the presence of stenosis ≥50% or occlusion in the superficial femoral and/or popliteal artery. After crossing of the lesion patient will be supposed to randomization. In the intervention group the angioplasty balloon will be inflated for 6 minutes. In the control group - for 3 minutes. Presence and severity (grades A-B or C-F according to NHLBI classification) of dissection will be assessed independently by 3 study investigators basing on completion angiography. Decision to classify the dissection as severe (grade C-F) and to perform the bailout stenting will be done by the agreement between at least 2 investigators. Sample size. Basing on the results of previous retrospective study investigators expect the 23% rate of severe dissection in study group (6 minutes inflation) and 51% - in control group (3 minutes inflation). Using the probability of type I error of 0.05 and power set at 80% investigators have calculated that 45 patients are required for each group. Anticipating 10% rate of loss to follow-up, 50 patients will be randomized per treatment arm. Randomization. One hundred patients will be allocated to study or control group by two blocks 1:1 randomization using the free online application Research Randomizer, version 4 (Urbaniak GC, Plous S., 2013, http://www.randomizer.org/). Follow-up. Three follow up visits at 1, 6 and 12 months are scheduled.
The objective of this study is to determine if patients with lower extremity wounds in rural communities who undergo specialty referral through telemedicine have expedited care compared to patients who are treated through standard in person referral.
All diagnostic procedures of peripheral arterial disease (PAD) in the diabetic foot (DF) are limited due to diabetes mellitus and its late complications. The aim of our study is to refine the diagnosis of peripheral arterial disease (PAD) by a new transcutaneous oximetry (TcPO2) stimulation test (a modified Ratschow test) in patients with diabetic foot.
The study will focus on effectiveness and safety of rivaroxaban (Xarelto) when given together with acetylsalicylic acid (combination therapy) to patients suffering from coronary artery disease (a condition that affects the blood vessels supplying the heart) and / or peripheral artery disease (a condition that affects the blood vessels of the lower limbs) in the routine clinical practice. The study will help to collect data for prevention cardiovascular death, myocardial infarction (MI), stroke and major adverse limb events in adult patients. The study will focus on information on when and why physicians are starting to treat patients with combination therapy, treatment duration, reasons to discontinue treatment and previous therapies. The study will also investigate treatment outcomes for patients being treated with a combination therapy by their physicians.
This study intends to evaluate the efficacy of a multidisciplinary vascular care team utilizing an intensive guideline-based lipid reduction program in improving risk factor modification as measured by LDL-C reduction at 12 months in patients with peripheral artery disease (PAD). An additional objective is to understand the potential reach and impact if this program were extended across the University of Colorado Healthcare (UC Health) System.
The study is aimed at evaluating the role of the activity of the key hemostatic parameters of endothelial dysfunction (nitric oxide II (NO) metabolites, plasmin activator inhibitor-1 (PAI-1), von Willebrand factor (vWF), coagulation factor VIII (FVIII), soluble endothelial protein C receptors (sEPCR)) in the development of disease progression, thrombotic complications and restenosis in subjects with atherosclerotic peripheral artery disease.
This study is designed to collect data on the complication rates and procedural success of using a transradial access approach to treat peripheral lesions in the lower extremities of a real world population.
This study postulates that the application of Sirolimus, an anti-proliferative agent that inhibits neointimal hyperplasia, via Sirolimus coated balloon (SCB) will be safe and will result in better arterial patency in infrainguinal peripheral arterial disease (PAD). The aim is to evaluate the efficacy (12 month freedom from clinically driven target lesion revascularisation) and safety (freedom from major adverse events) of sirolimus coated balloons in the treatment of infrainguinal PAD.
One in every two deaths in the United States is caused by cardiovascular disease. Despite strong mechanistic links established between a diet rich in lipids and the pathogenesis of cardiovascular disease, therapeutic advances have focused on reduction in either ingestion or synthesis of cholesterol, and reduction in dietary trans and saturated fatty acids and triglycerides. Even in the setting of aggressive high potency statin therapy and global cardiovascular risk reduction efforts, most clinical trials reveal a significant residual cardiovascular risk with, at best, only 30% reduction in major adverse cardiovascular events. There exists a significant unmet clinical need for identifying novel therapies for the prevention and treatment of cardiovascular disease. This requires identification of additional contributory processes to cardiovascular disease pathogenesis, so that mechanism-based interventions may be developed. Endothelial dysfunction is a pathological state in which there is systemic inflammation of vascular endothelium with consequent expression of pro-vasoconstrictive mediators, thrombotic and atherogenic tendencies. Endothelial dysfunction precedes the development of atherosclerosis and portends an increased risk of future adverse cardiovascular events. Endothelial dysfunction, therefore, can serve as a "barometer" of future cardiovascular risk. Measurement of Flow-mediated dilation ( FMD) is widely accepted as a method to assess vascular endothelial function.
Digital Variance Angiography (DVA) is a new tool in medical imaging with proven image quality reserve. The previously observed quality reserve of Digital Variance Angiography (DVA) in lower extremity angiographies, allowed to lower radiation exposure by 70 % during DSA in lower extremity diagnostic angiographies with non-inferior image quality. The aim of this study is to apply this non-inferior image quality and use it for radiation exposure reduction in diagnostic lower limb angiography. The project would prospectively block-randomise (50:50) patients, who undergo elective diagnostic angiography into two groups: a comparator group examined by means of conventional DSA using a standard care protocol (Siemens Artis Zee, Extremities Care setting, 1.2 µGy/frame) (Group B) and a study group examined by means of DVA using a low-dose protocol (0.36 µGy/frame corresponding to 70% decrease of radiation dose) (Group A). During each procedure the investigators record radiation exposure (cumulative dosage, dose area product) and contrast media usage and procedural time then compare the results of the groups. Qualitative image review is done to compare conventional DSA and reduced radiation exposure DVA images after image acquisition. Our hypothesis is that with the previously proven non-inferior image quality, the investigators will be able to reduce radiation exposure of the participants and also staff members in everyday clinical practice.