Active clinical trials for "Peripheral Arterial Disease"

Objective of this study is to evaluate the safety and efficacy of Lutonix 035 Drug Coated Dilatation PTA Catheter with Bard LifeStent Vascular Stent (hereinafter referred to as LifeStent) for treatment of long (10-24 cm) lesions in the SFA and/or proximal popliteal artery.

This pilot study is to investigate if a lesion preparation strategy with Phoenix atherectomy before DCB (drug coated balloon) usage in patients with PAD (peripheral artery disease) Rutherford Stage 4-5 and mild/moderate/severe calcium can improve outcomes including patency and limb salvage and evaluate safety and performance of the combination therapy

Background: Many patients with peripheral artery disease are unable to achieve healthy lifestyle after revascularization. There is evidence that rehabilitation program could result in decreased re-admission, reduced cardiometabolic risk factors and improved quality of life. Aim: This first randomized controlled trial to examine the effectiveness of mobile phone text message-based rehabilitation on low density lipoprotein (LDL), Ankle Brachial Index (ABI), healthy lifestyle behaviors and quality of life for patients after revascularization. Methods: This is a 6 months randomized controlled trial. It is hypothesized that message-based rehabilitation program will be effective in improving the low density lipoprotein (LDL), Ankle Brachial Index (ABI), healthy lifestyle behaviors and quality of life for patients with peripheral artery disease after surgical revascularization. A total of 160 participants will be recruited for the study. The participants will be randomly divided into intervention and control groups. Both intervention and control groups will receive face-to-face lifestyle adherence counseling and booklet at baseline. The intervention group will receive 4 mobile phone messages per week for 24 weeks. All participants will be asked to fill in the questionnaires at the baseline, 6-week and 6-month follow-up in Surgical Out Patient Department (SOPD). Participants' blood results of low density lipoprotein (LDL) at the baseline and at 6-month follow-up will be retrieved from Computer Management System in SOPD The primary outcomes are the fasting LDL levels at 6 months. Secondary outcome are Ankle-Brachial Index (ABI), BMI, Fasting glucose level, HDL level, Total cholesterol level, self-reported adherence to healthy lifestyle behaviours, quality of life and smoking status. Participants: The target participants of this study are peripheral artery disease patients who have received revascularization in the Surgical Department of a regional hospital in Hong Kong. The eligible participants are Chinese, aged 50 years or above, and with medical record of peripheral artery disease with revascularization done in the past 6 months. The participants should be able to receive and read Chinese texts from their own mobile phones and are available to come back for a 6-month follow-up for lifestyle counselling. The potential participants will be excluded if they refuse to provide an informed-consent form or if they have medical records stating their lack of capacity to provide informed consent. The recruitment procedure will take place in Department of Surgery in a regional hospital. Study setting: The study will be conducted in the Surgical Department of a regional hospital in Hong Kong.

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.

The association between obesity and cardiovascular disease (CVD) has mostly been studied using broad endpoints or have focused on cause-specific mortality. The investigators aim to compare the effect of body mass index (BMI) on different types of initial presentation of CVD.

This study is designed to develop a clinical registry of Peripheral Arterial Disease (PAD) patients undergoing lower extremity revascularization to describe the population and assess comparative effectiveness of endovascular therapy versus surgery. In addition, this study will conduct a prospective cohort study of patients treated medically or undergoing lower extremity revascularization at the VA and Kaiser Colorado to compare changes in health status.

The purpose of this study is to test a correction factor which would allow ankle brachial indexes taken in the seated position to accurately predict an ankle brachial index taken in the supine position.

In an observational multi-centre study (HEROS), the effects of starting treatment with rosuvastatin were assessed, on low-density lipoprotein cholesterol (LDL-C) goal achievement, in patients with a dissimilar high-risk profile who had not been treated with cholesterol lowering drugs at least in the past three months. Also set-up costs of rosuvastatin treatment and proportional changes in LDL-C and high-density lipoprotein cholesterol (HDL-C) were studied.

Magnetic Resonance Angiography (MRA) of the peripheral arteries has become essential in the diagnosis and follow-up of peripheral arterial disease. In clinical routine, the acquisition uses intravenous injection of a Gadolinium based contrast agent (gadolinium chelates). Initially, contrast enhanced MR angiography (CE-MRA) was recommended for diabetic patients, elderly patients and\or patients with chronic renal insufficiency presenting a contraindication to CT angiography using iodized contrast agent injection. However, the increase in nephrogenic systematic fibrosis clinical cases, which would be secondary to gadolinium chelates injection, in patients with chronic renal insufficiency has restricted the use of CE-MRA. More than 500 cases were described to date in the world. Its occurrence is currently estimated around 4 % for patients in terminal chronic renal insufficiency and its mortality around 30 %. According to the recommendations of AFSSAPS from August, 2007, two gadolinium contrast agents (Gadodiamide-OMNISCAN *, General Electric HealthCare and Gadopentetate Dimeglumine-MAGNEVIST *, Bayer HealthCare) are contraindicated if the glomerular filtration rate is lower than 30 ml/mn. Non-contrast enhanced MR angiography (NCE MRA) techniques have been proposed to provide complete and non-invasive investigation of the peripheral vasculature, from the abdominal aorta to the calf, thus offering patients with chronic renal insufficiency a surrogate with no side effects. Moreover, the use of high field (3T) MR imaging and phased array coils offers high quality images and good signal to noise ratio for peripheral vasculature analysis. Besides, the acquisition can be repeated if required as it does not require any contrast injection. The main objective is to evaluate the quality of the NCE images obtained for every investigated station from the abdominal aorta to the calf. The secondary objective is to compare the diagnostic performances of NCE images with those of CE MRA. The third objective is to estimate the contribution of automated and dedicated post-processing tools in optimizing the diagnostic quality of the images.

The purpose of this study is to assess the ability of a vascular stent to maintain an open iliac (leg) artery. The Zilver Vascular Stent is made of nitinol, a flexible metal with a long history of use in medical devices. The stent self-expands once inside the artery where it is intended to hold the vessel wall open. Within a few weeks, a layer of cells will grow over the stent helping to hold it in place.