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Peripheral Arterial Disease clinical trials

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NCT ID: NCT04197609 Not yet recruiting - Clinical trials for Peripheral Artery Disease

Static Muscular Stretching for Treatment of Peripheral Arterial Disease

Start date: February 1, 2020
Phase: N/A
Study type: Interventional

Researchers are evaluating the effects of static muscle stretching on endothelial function, skeletal muscle oxygenation and walking function in patients with peripheral artery disease.

NCT ID: NCT04175197 Not yet recruiting - Clinical trials for Peripheral Arterial Disease

LegDeb2 Global Registry for Use of Legflow in Peripheral Arteries

LEGDEB2
Start date: November 2019
Phase:
Study type: Observational

LEGDEB2 is a Global Registry for the Treatment of Superficial Femoral and/or Popliteal or Below-The-Knee or Iliac Artery Lesions Using the Legflow Drug-Eluting Balloon

NCT ID: NCT04155476 Not yet recruiting - Clinical trials for Peripheral Arterial Disease

Ultrasound Evaluation of Lower Extremity Arteries After Topical Nitroglycerin Administration

Start date: December 30, 2019
Phase: Early Phase 1
Study type: Interventional

There have not been any published studies showing the use of topical nitroglycerin on the dilatory effect on the posterior tibial or dorsalis pedis arteries. The objective of this study is to determine the response of the posterior tibial artery and dorsalis pedis artery to topical administration of nitroglycerin. This study may provide further information for the utility of this artery in the treatment of peripheral arterial disease.

NCT ID: NCT04123639 Not yet recruiting - Clinical trials for Peripheral Arterial Disease

Outcomes of Endovascular Treatment of Superficial Femoral Artery In-stent Restenosis

Start date: October 1, 2019
Phase: N/A
Study type: Interventional

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 .

NCT ID: NCT04054232 Not yet recruiting - Clinical trials for Peripheral Artery Disease

Evaluation of an Electronic Health Record-based Screening Tool for Peripheral Artery Disease

Start date: December 2023
Phase: N/A
Study type: Interventional

This protocol represents a pilot randomized-controlled trial evaluating the effect of an electronic health record (EHR)-based peripheral artery disease (PAD) screening tool on rates of new non-invasive testing, diagnosis and treatment of PAD over a 6-month period. An EHR-based PAD screening tool will be applied to the Stanford EHR, which will generate a group of patients of varying risks of having undiagnosed PAD. Patients with the highest risk of having undiagnosed PAD will then be evaluated for inclusion in this study. 1:1 randomization will be performed on a consecutive basis until study enrollment is completed (25 patients per arm). Physicians of patients randomized to the intervention arm will be sent notification via an EHR message detailing the patient's risk of undiagnosed PAD and suggestions for referral to vascular medicine for risk assessment and/or non-invasive ankle brachial index (ABI) testing. The primary outcome is number of patients receiving ABI testing for PAD at 6 months, with secondary outcomes including number of new PAD diagnoses, number of new referrals to cardiovascular specialists (vascular medicine, vascular surgery, and/or cardiology) and number of patients receiving initiation of new cardiovascular medications (anti-platelet agents, statins, and/or antihypertensive agents).

NCT ID: NCT04025008 Not yet recruiting - Clinical trials for Peripheral Arterial Disease

A Clinical Evaluation of the MicroSTent® PeripherAl Vascular SteNt in Subjects With Arterial Disease Below the Knee

STAND
Start date: October 2019
Phase: N/A
Study type: Interventional

This prospective pivotal study is a double arm, randomized multi-center study evaluating the safety and performance of the MicroStent peripheral vascular stent system for use in arterial lesions below the knee. A total of 177 subjects will be enrolled at up to 25 centers and followed for up to 3 years, with the primary safety and efficacy endpoints evaluated 30 days and 6 months, respectively, post-implant.

NCT ID: NCT03974880 Not yet recruiting - Clinical trials for Peripheral Artery Disease

Predicting Outcomes of PAD Patients Undergoing Endovascular Intervention With CTA

Start date: July 1, 2019
Phase:
Study type: Observational

Lower extremity peripheral artery disease (PAD), the third leading cause of atherosclerotic cardiovascular morbidity following coronary artery disease and stroke, affect 200 million people worldwide and is associated with high rates of cardiovascular events and death. Consensus is reached on an "endovascular-first-strategy" for symptomatic PAD who have developed critical limb ischemia. However, the challenge of endovascular therapy is the long-term patency, and the associated worse clinical outcomes, including higher rates of major adverse cardiovascular events, and major adverse limb events. Meta-analysis concluded that restenosis occurred rate 5-70 % at 1 year; the incidence of adverse limb outcomes, (including worsening of symptoms, the need for peripheral revascularization, and amputation) was 26% over a period of 4 years; Cardiovascular morbidity and mortality up to 28 % after endovascular therapy. There are no consensus guidelines on the optimal timing and the factor on adverse clinical outcome remains uncertain. Therefore, the purpose of this study is to conduct a structured surveillance plan for follow-up care and evaluate risk factors that will eventually support development of a predictive model for clinical outcomes of endovascular procedures to treat lower extremity PAD.

NCT ID: NCT03948087 Not yet recruiting - Edema Leg Clinical Trials

Comparison Between Postoperative Tubular Dressing and a Vacuum Removable Rigid Dressing After Transtibial Amputation

EMPAR
Start date: May 2019
Phase: N/A
Study type: Interventional

Comparison of wound healing, edema level, knee range of motion, rate of revision post falls, device application time, time to prosthetic fit, and cost between postoperative soft dressing and a vacuum removable rigid dressing after unilateral transtibial amputation.

NCT ID: NCT03845036 Not yet recruiting - Clinical trials for Peripheral Artery Disease

The Effects of Diet and Exercise Interventions in Peripheral Artery Disease

Start date: June 3, 2024
Phase: N/A
Study type: Interventional

This study is a 3-month, prospective, randomized controlled clinical trial designed to address the efficacy of the DASH dietary program combined with a home-based exercise program, quantified by a step activity monitor, to improve exercise and vascular outcome measures in patients with PAD.

NCT ID: NCT03826836 Not yet recruiting - Heart Failure Clinical Trials

Mind Our Heart Study

Start date: January 2019
Phase: N/A
Study type: Interventional

Patients with atherosclerotic cardiovascular disease (i.e. peripheral artery disease, ischemic heart failure, myocardial infarction) are randomised to (1) treatment as usual (i.e. best medical care) or (2) treatment as usual (i.e. best medical care) in combination with an eight-week mindfulness-based stress reduction programme.