View clinical trials related to Peripheral Arterial Disease.
Filter by:This study aims to conduct a randomized, double blind, randomised controlled multicentre trial of sirolimus drug coated balloon versus standard percutaneous transluminal angioplasty for the treatment of superficial and popliteal arterial disease.
The SAFE-PAD Study aims to evaluate the long-term safety of paclitaxel-coated devices compared with non-paclitaxel-coated devices for femoropopliteal artery revascularization among a broad, real-world population of patients with peripheral artery disease. This multi-year analysis aims to create an ongoing mechanism to evaluate the safety of paclitaxel-coated devices in real world practice. The null hypothesis is that the paclitaxel-coated devices are associated with an increase in mortality relative to the non-drug-coated devices beyond an acceptable magnitude (i.e. the non-inferiority margin), and the alternative hypothesis is that paclitaxel-coated devices are not associated with an increase in mortality relative to the non-drug-coated devices beyond the non-inferiority margin.
A cross-sectional, non-interventional study to assess walking performance, vascular function, and lower limb calcification in subjects with peripheral artery disease and end-stage kidney disease (PAD-ESKD) receiving hemodialysis.
This study is a prospective, interventional, multi-center 1:1 randomized non-inferiority trial. The trial evaluates the safety and efficacy of the Magic Touch PTA sirolimus drug-coated balloon in comparison to the treatment with PTX drug-coated balloon (control device) in patients with femoropopliteal artery disease.
one-centered, open, non-randomized, controlled clinical trial will focus on a comprehensive study of the clinical, functional and molecular biochemical characteristics of the natural course of COPD in combination with peripheral atherosclerosis
To utilize near-infrared spectroscopy to investigate if the research device, which induces muscle stretching, and creatine loading impact submaximal exercise performance in aged and PAD patients. Near-infrared spectroscopy (NIRS)-derived tissue oxygenation responses will be obtained during device placement (muscle stretch) and during a walking test (i.e., six-minute walk test). Muscle oxygenation at rest and during device placement will be assessed with Magnetic Resonance Imaging. It is hypothesized that the stretching protocol will improve both NIRS-derived tissue oxygenation and magnetic resonance-derived muscle oxygenation and that creatine supplementation will further improve phosphorus metabolite muscle performance. All patients will undergo either 4 weeks of stretch training with- or- without creatine supplementation according to previously defined creatine guidelines.
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.
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.
Continuous Doppler ankle brachial index (ABI) is the gold standard for screening and monitoring of peripheral arterial disease (PAD) but is no longer carried out in clinical practice. The recommended measurement was gradually replaced by colour or pulsed Doppler without validation of these techniques. The objective of our study is to compare these two techniques (color Doppler and pulsed Doppler in echodoppler) with respect to the gold standard (continuous Doppler) for ABI measurement.