Active clinical trials for "Peripheral Arterial Disease"

The MIMICS-3D study will evaluate safety, effectiveness and device performance within a real-world clinical population of patients undergoing femoropopliteal intervention.

Observational registry including patients with peripheral artery disease due to femoro-popliteal stenosis or occlusion treated with cutting ballon- and subsequent drug-coated-ballon-percutaneous-transluminal-angioplasty (PTA).

Peripheral Artery Disease (PAD) is a major risk factor for lower limb amputation. Microvascular reactivity assessed with near-infrared spectrometry has been studied in people with PAD but not in people with limb loss (PLL) who have PAD. The purpose of this research is to explore whether near-infrared spectrometry measures can contribute to identifying people at risk for amputation. Specific aims include: 1) Determine the test-retest reliability of near-infrared spectrometry measures in people with peripheral artery disease with or without major unilateral amputation. 2) Determine construct validity of near-infrared spectrometry measures compared to 6-Minute Walk Test, and time to claudication onset; and self-reported prosthetic mobility in people with transtibial amputation. This methodologic prospective study with repeated assessments and long term phone follow-up every year to identify any subjects that undergo revascularization or amputation will include 2 groups of subjects: a PAD group enrolled from an out-patient walking program, and a PLL+PAD group who receive no care but have their walking step counts monitored.

Post market clinical follow up of Bycross® device.

Heparin-Binding protein is a protein from primary and secretory granluae of white blood cells. It is released when white blood cells become activated and has been advocated as a biomarker for sepsis. The aim of this study is to find out if Heparins in clinical doses can change the level of Heparin-binding protein in plasma.

Peripheral artery Disease (PAD) is a major cardiovascular disease that can impair quality of life (QoL). It affects more often male patients and its pathophysiology is not completely known. Probably androgen receptors and metabolism alteration may play an important role in the onset and in the progression of PAD towards its dreadful complications. The aim of this study is to evaluate the role of Androgen Recetpr , IGF-I receptor, and Insulin Receptor on the arterial wall of male patients with PAD undergoing open revascularization surgery.

Prospective observational study of MicroNet covered stent implantation in the elevated risk peripheral lesions (high lesion load, thrombus containing, highly calcified). Open-label, non randomized, single arm observational study. Jagiellonian University Medical College research project.

This is a phase IV, prospective biomarker study that will be conducted at Sinai Hospital of Baltimore. After screening for patients who were treated with aspirin, thirty patients will be treated with 81 mg enteric coated (EC) aspirin for 7 days in the "lead-in" period and then will be randomly treated with EC aspirin (81mg qd) or EC aspirin (81mg qd) plus rivaroxaban (2.5 mg bid) for 12 weeks. Platelet aggregation, soluble markers of platelet activation and inflammation, thrombin generation kinetics and tissue factor (TF)-induced platelet-fibrin clot strength will be assessed at baseline (after 7 days of treatment with 81 mg EC aspirin), and 4 and 12 weeks after randomization of the study drug administration.

Nearly one-half of all lower extremity percutaneous interventions performed in patients with symptomatic peripheral artery disease (PAD) involve chronic total occlusions (CTOs) which are technically more challenging and are associated with more periprocedural complications and lower rates of procedural success comparing with non CTOs. Despite innovate dedicated CTO devices developed and provides higher technical success, a wire-catheter approach to cross peripheral artery CTO is most often the first choice of operators as its lower cost advantage.Subhash Banerjee MD reported of all 1,362 CTOs, wire-catheter approaches were used in 82% and the technical success rate was 65%. If the operators chose wire-catheter as primary crossing device at the beginning of the procedure, but the technically failed with the provisional use of re-entry or crossing devices to try to procedural success. Such procedures add incrementally to procedure duration and cost and the revascularization and amputation rate at 12 month were highly increased comparing with using dedicated CTO devices initially. So it is very important to predict the outcome of guidewire crossing through CTOs to direct the choice of crossing strategy. Current data suggested that computed tomography angiography (CTA) imaging of PAD and a detailed comprehensive assessment for CTO arteries before endovascular therapy can assist preprocedural planning to maximize procedural success. Previous studies about coronary CTOs prediction scores as the KCCT score and CT-based CT-RECTOR provide the factors including occlusion length, the shape of proximal entry site, severe calcification, and etc. characters base on CTA correlating with the outcome of cross. As the same physiopathologic mechanism, we hypothesized that the radiographic characteristics are connected with outcomes of guidewire crossing occlusions. To our knowledge, few studies focused on how to predict the successful GC through peripheral artery CTO, therefore, the purpose of this study was to establish a simple and clinically applicable prediction model based on CTA characters within the occlusive lesions and clinical parameters to predict the GC outcomes of patients with lower extremity CTO. In addition, the long-term effect of endovascular revascularization are very important. An analysis concluded that limb adverse event (repeat revascularization rate 17.2%, amputation rates 8.5%) at 12-month in the CTOs with direct wire-catheter crossing strategy. Base on the proven influence factors (the lesion length, small diameter of the vessel and severe calcification, mechanical exposure, etc.)of adverse event at after endovascular revascularization ,we also can establish model with preoperative computer tomography angiography that provided the lesion detail characteristic combing the patients' biochemical and clinical feature to predict the adverse event rate at 12-month after endovascular revascularization.

Cardiovascular disease (CVD), a condition predominantly caused by atherosclerosis, is the leading cause of morbidity and mortality in the investigator's society. Peripheral arterial disease (PAD), a subset of CVD, occurs when the atherosclerosis progresses to compromise the lower extremity circulation resulting in ischemic symptoms. Although atherosclerosis has been generally regarded as a disease of developed or affluent countries, recent evidence showed a progressive rise in the prevalence of CVD in developing countries where an epidemiological shift of disease prevalence patterns from infectious illnesses to atherosclerotic disease has occurred. Management of CVD, particularly with an emphasis of disease prevention, will undoubtedly play an increasing vital role in the health care system around the world. Endothelial dysfunction, as reflected by the impaired arterial vasodilatory capacity, represents one of the pathogenic mechanisms linking atherosclerosis and cardiovascular mortality. The ability of arteries to dilate in response to stimuli is a significant indicator of underlying vascular endothelial function and associated CVD. Factors modulating vasodilatory response include the release of vasoactive compounds such as nitric oxide (NO) from the endothelium and vascular compliance. In healthy individuals, a major mechanism responsible for vasodilation is the hyperemic-stimulated release of NO from the endothelium, resulting in vascular smooth muscle relaxation with subsequent vasodilation. Vascular endothelial function can be assessed using a non-invasive technique to determine brachial artery reactivity whereby a high-resolution ultrasound is used to measure changes in brachial artery diameter to endogenous production of endothelium-derived NO via flow-mediated dilation (FMD). Therefore, reduced FMD has been described as a reliable indicator of vascular endothelial dysfunction as well as presence of underlying CVD risk factors and related diseases. Recent studies have similarly shown that arterial pulse-wave velocity (PWV), which is a non-invasive evaluation of arterial stiffness, is a reliable indicator of vascular function. While numerous studies have documented the benefit of dietary intervention in the reduction of CVD related sequelae, limited data is available regarding whether the beneficial effect of dietary intervention are reflected in vascular endothelial function. The present study was therefore conducted to assess the effects of plant-based diet (PBD) on vascular endothelial function as assessed by FMD and PWV in patients with peripheral arterial disease (PAD).