View clinical trials related to Peripheral Vascular Diseases.
Filter by:Lower limb peripheral arterial disease (PAD) is a common, important manifestation of systemic atherosclerosis. Stenosis or occlusions in the superficial femoral artery (SFA) may result in intermittent claudication or even critical ischemia, which may be treated by balloon angioplasty with or without stenting . Atherosclerotic disease in the femoropopliteal (FP) artery consists of perfusion to the legs and feet. Percutaneous transluminal angioplasty (PTA) has been routinely used to manage FP artery disease and is recommended as an alternative to surgical bypass. Recently, newer endovascular approaches such as covered stent, drug-eluting balloon (DEB), drug-eluting stent (DES), or catheter based atherectomy have been introduced as treatment options for FP artery disease. Nevertheless, FP artery-in stent restenosis (ISR) is still a major challenge with endovascular therapy . Although the use of peripheral arterial stents brought about a dramatic improvement in patients' clinical and procedural outcomes, the long-term outcome of stent implantation remains significantly constrained by the risk of developing in-stent restenosis (ISR) over time. Advancements in endovascular stent technology have addressed limitations associated with conventional percutaneous transluminal balloon angioplasty in patients with chronic peripheral arterial disease (PAD) of the lower limbs, such as elastic recoil,residual stenosis and flow-limiting dissection . However, a considerable proportion of patients with PAD treated with stenting will require secondary interventions due to in-stent restenosis (ISR), which is particularly common in long and complex lesions ISR refers to loss of luminal volume from an ingrowth of cells, extracellular matrix, and thrombus within the cylinder of the stented artery and 5-mm margins proximal and distal to the stent. ISR has been reported to occur in 18-40% of patients undergoing stenting in the femoropopliteal segment within the first year of treatment . The treatment of ISR is one of the major challenges in endovascular therapy for PAD. The treatment options for ISR include standard balloon angioplasty with or without repeat stenting (using bare-metal stents, stent grafts or drug-eluting stents), drug-coated or cutting balloon angioplasty, cryoplasty and directional or laser atherectomy .
Intermittent claudication (IC), the most common manifestation of peripheral artery disease (PAD), represents not only a significant detriment in quality of life, but also an increased risk for atherosclerotic cardiovascular disease (ASCVD), including progression of PAD, coronary artery disease (CAD) and cerebrovascular disease. Guideline directed therapy for IC includes supervised exercise, smoking cessation and optimal medical management to decrease overall risk of ASCVD. In the VA Health Care System, implementation of supervised exercise therapy through cardiac rehabilitation or physical therapy programs is limited by distances that patients must travel to VA facilities that provide these services. Furthermore, one of the most common failure points in exercise therapy programs is poor patient compliance. Improved patient participation and compliance in exercise programs for IC represents an unmet need, without which the majority of patients with life-style limiting PAD may not be receiving optimal medical management. Small studies have demonstrated the effectiveness of home-based exercise programs as an alternative to supervised exercise therapy; however, the success of the home-based exercise programs require remote coaching and/or regular provider feedback. The wide-spread availability of smart phones and smart devices has accelerated the implementation of telehealth programs that may supplement or may eventually replace in-person encounters for health care delivery. The role of provider feedback in addition to real-time feedback from smart devices remains completely unexplored. Our central hypothesis is that in individuals with IC, regular provider feedback on smart-device-based remote health monitoring data, which is available to the patient in real time, will augment the benefits of home-based exercise programs. We propose a randomized trial in patients with IC to test the central hypothesis through two Specific Aims: 1. To determine the effect of provider feedback on smart-device-based remote health monitoring data during home-based exercise programs on walking distance in patients with IC. 2. To determine the effect of provider feedback on smart-device-based remote health monitoring data during home-based exercise programs on quality of life (QOL) in patients with IC. Based on a sample size calculation to detect a 50% increase in walking distance between the 2 groups, we expect to enroll 30 patients (15 in each group). Patient participation in the study will be concluded after 12 weeks. As an exploratory aim in the study, we will also (as an optional part of the study) collect plasma before and after the 12-weeks of exercise to investigate changes in lipid levels and plasma biomarkers associated with exercise therapy. This exploratory aim will generate preliminary data for future studies.
Non-randomized, multicenter, combined prospective and retrospective cohort analysis consisting of a single arm treated with the MicroStent™ System.
The VQI-DELTA Paclitaxel Device Safety Analysis seeks to assess the comparative safety of paclitaxel coated balloons and stents in the treatment of peripheral artery disease (PAD) through analysis of the VQI Peripheral Vascular Intervention (PVI) registry module using the DELTA system.
The muscles of the leg require a regular supply of oxygen and nutrients. This is supplied by blood carried by a network of large blood vessels known as arteries. Gradually, these arteries can become narrowed or blocked by a build-up of fatty deposits. This process is known as atherosclerosis and leads to a condition called peripheral arterial disease. The restriction of blood flow caused by the blockage prevents exercising muscles getting enough oxygen and nutrients. In some people, this may lead to a painful ache in their legs when they walk, known as intermittent claudication. If the leg pain is severe, surgeons may decide to bypass this blockage using a vein taken from another part of the body, thereby improving blood flow to the foot. Patients with a narrowing or blockage anywhere in the main artery that runs from the groin to the back of the knee may be treated with a particular type of bypass graft known as a femoral-popliteal bypass graft. However, this graft may collapse if not enough blood is flowing through it. This study is looking to see whether a circulation booster machine, known as the REVITIVE® device, can improve the amount of blood flowing through femoral-popliteal bypass grafts. Patients with these grafts attending their usual clinic appointment in the Vascular Outpatients department at Charing Cross Hospital, London will be asked to have their leg scanned using an ultrasound machine to measure the amount of blood flowing through the graft. They will then use the REVITIVE® device for 30 minutes, before being re-scanned to see whether the device has improved blood flow. Improvements in blood flow may suggest a promising role for the device in keeping these grafts open, therefore helping them last longer and potentially reducing the leg pain associated with peripheral arterial disease.
To evaluate the safety and performance of the Sundance™ DCB in subjects with occlusive disease of the infrapopliteal arteries.
The objective is to ensure the pro-active collection of information on quality, safety and performance of FlowOx™ after it is placed on the market. The study will be carried out in a patient population with peripheral artery disease (claudicatio intermittens) to confirm its usefulness and in particular gather information for further improvements of the device related to this patient population. The data collected from the use of the CE-marked FlowOX™ device are change of walking distance, quality of life, and the patient's compliance.
Interventional strategies aim to restore tissue perfusion. However, despite the simple reopening of a narrowed artery they affect endothelial function, perpetuating dysfunctional vascular homeostasis. PTA and atherectomy might alter the endothelial function but the mechanisms are incompletely understood. The primary goal of atherectomy is vessel preparation and improving compliance, which could aid in preserving vessel functions. Aim of this study is to determine safety, efficacy, patency and vessel functions in the femoropopliteal artery following atherectomy and DCB.
MicroRNA-210 (miR-210) can be a potential therapeutic target of patients with peripheral artery disease (PAD). Recent evidence suggests the role of miR-210 and oxidative stress in the pathophysiology of PAD and its association with mitochondrial function, oxidative metabolism, walking distances and quality of life. The protocol evaluates the mechanisms which miR-210 regulates oxidative stress and provides evidence of potential therapeutic strategies.
This study will focus on determining; - How accurate the test is in detecting poor circulation - How it's accuracy compares to other commonly used tests, and - Whether test results are linked to the chance of ulcer healing or amputation. Across 2 hospitals, 305 diabetic patients will be scanned using the focused ultrasound test as well as other commonly used tests to detect poor circulation. Their results will be compared to a full version of the ultrasound test to identify the most accurate.