Peripheral Arterial Disease Clinical Trials

In recent years, mobile health (mHealth) apps have promised improved monitoring of health conditions to improve clinical outcomes. The objective of this study is to conduct a pilot randomized clinical trial (RCT) to evaluate the impact of using remotely collected patient generated health data (PGHD) from older patients undergoing bypass surgery due to chronic limb threatening ischemia. The hypothesis is that integrating PGHD with an EHR system will help providers manage post-surgical symptoms and thus improve post-operative mobility and quality of life health outcomes. Read Less

The objective of this study is to establish reasonable assurance of safety and effectiveness of the Golazo® Peripheral Atherectomy System when used as indicated in 159 subjects with symptomatic infrainguinal peripheral arterial disease (PAD) in up to 15 investigational sites in the U.S. Read Less

This real-world, observational registry captures structured data on chronic wounds and ulcers from 1,482 practitioners across all 50 U.S. states and Puerto Rico. Data are collected at the point of care through electronic health records (EHRs) or electronic data capture (EDC) systems and transmitted daily to the U.S. Wound Registry (USWR), a CMS-recognized Qualified Clinical Data Registry (QCDR). The registry supports quality improvement and comparative effectiveness research by providing insight into patient demographics, treatment patterns, and outcomes across a wide range of wound types and interventions. Read Less

This study aims to demonstrate superior efficacy and equivalent safety of the SELUTION SLR™ DEB 014 compared to plain (uncoated) balloon angioplasty in the treatment of peripheral arterial disease (PAD) in the BTK arteries in CLTI patients. Read Less

Peripheral artery disease (PAD) is a manifestation of atherosclerosis that produces progressive narrowing and occlusion of the arteries supplying the lower extremities. The most common clinical manifestation of PAD is claudication, i.e., a severe functional limitation identified as gait dysfunction and walking-induced leg muscle pain relieved by rest. The standard therapies for claudication include the medications cilostazol and pentoxifylline, supervised exercise therapy and operative revascularization. Recent data demonstrated that 24 weeks of treatment with the angiotensin-converting enzyme (ACE) inhibitor Ramipril produces improvements in the walking performance of patients with claudication that are higher than those of cilostazol and pentoxifylline and similar to those produced by supervised exercise therapy and operative revascularization. The mechanisms by which Ramipril therapy produces this impressive improvement in the functional capacity of claudicating patients remain unknown. The Investigators hypothesize that treatment of claudicating PAD patients with Ramipril will improve walking performance and quality of life by improving the myopathy of the gastrocnemius. Improved myopathy is a consequence of reduced oxidative damage, reduced TGF-β1 production by vascular smooth muscle cells and reduced collagen deposition in the affected gastrocnemius. Read Less

The purpose of this study is to determine whether carnosine (a food ingredient found in chicken and red meat) supplementation (2 g) for 6 months in participants with non-claudication and claudication peripheral arterial disease (PAD) improves walking ability. Previous studies with heart failure patients have shown that carnosine supplementation increases walking capacity in these patients. Read Less

This is a preliminary prospective observational study measuring change in lower extremity temperature in response to revascularization procedure. The main question this study aims to answer is: - Are temperature measurements from a forward looking infrared (FLIR) camera of the lower extremity useful in predicting outcome of revascularization procedures? Read Less

The purpose of this post-market surveillance study will be to evaluate the real-world use of the DETOUR System in treated patients with symptomatic femoropopliteal lesions from 200 mm to 460 mm in length with chronic total occlusions (100 mm to 425 mm) or diffuse stenosis \> 70% who may be considered suboptimal candidates for surgical or alternative endovascular treatments. Read Less

The PROWL registry is an open-label retrospective, multi-center, US study of the Surmodics™ Pounce™ Thrombectomy System for the non-surgical removal of emboli and thrombi in the peripheral arterial vasculature. Read Less

The purpose of this study is to develop a new noninvasive tool for early diagnosis of Peripheral Arterial Disease (PAD) and use the proposed method for monitoring the disease progression and the response to interventional treatment in PAD patients. Read Less

The objective of this prospective, multicenter, randomized, controlled clinical trial is to demonstrate the superiority of the VBX Device for primary patency when compared to bare metal stenting in complex iliac occlusive disease. Read Less

The purpose of this study is to understand how the drug rivaroxaban improves symptoms associated with peripheral artery disease. Read Less