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Peripheral Artery Disease clinical trials

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NCT ID: NCT04059679 Recruiting - Clinical trials for Coronary Artery Disease

Synergistic Influence of Rivaroxaban on Inflammation and Coagulation Biomarkers in Patients With CAD and PAD on Aspirin Therapy

Start date: January 30, 2020
Phase: Phase 4
Study type: Interventional

This is a phase IV, prospective biomarker study that will be conducted at Sinai Hospital of Baltimore. After screening for patients who were treated with aspirin, thirty patients will be treated with 81 mg enteric coated (EC) aspirin for 7 days in the "lead-in" period and then will be randomly treated with EC aspirin (81mg qd) or EC aspirin (81mg qd) plus rivaroxaban (2.5 mg bid) for 12 weeks. Platelet aggregation, soluble markers of platelet activation and inflammation, thrombin generation kinetics and tissue factor (TF)-induced platelet-fibrin clot strength will be assessed at baseline (after 7 days of treatment with 81 mg EC aspirin), and 4 and 12 weeks after randomization of the study drug administration.

NCT ID: NCT04007055 Recruiting - Clinical trials for Peripheral Artery Disease

The Value of Screening for HPR in Patients Undergoing Lower Extremity Arterial Endovascular Interventions

Start date: August 9, 2019
Phase: Phase 3
Study type: Interventional

This is a randomized controlled trial designed to evaluate the role of screening for and intervening on patients with high on treatment platelet reactivity undergoing lower extremity arterial endovascular interventions.

NCT ID: NCT03995238 Recruiting - Diabetes Mellitus Clinical Trials

Optimizing Gait Rehabilitation for Veterans With Non-traumatic Lower Limb Amputation

GEM
Start date: October 9, 2019
Phase: N/A
Study type: Interventional

The population of older Veterans with non-traumatic lower limb amputation is growing. Following lower limb amputation, asymmetrical movements persist during walking and likely contribute to disabling sequelae including secondary pain conditions, poor gait efficiency, impaired physical function, and compromised skin integrity of the residual limb. This study seeks to address chronic gait asymmetry by evaluating the efficacy of two error-manipulation gait training programs to improve gait symmetry for Veterans with non-traumatic lower limb amputation. Additional this study will evaluate the potential of error-manipulation training programs to improve secondary measures of disability and residual limb skin health. Ultimately, this study aims to improve conventional prosthetic rehabilitation for Veterans with non-traumatic amputation through gait training programs based in motor learning principles, resulting in improved gait symmetry and lower incidence of long-term disability after non-traumatic lower limb amputation.

NCT ID: NCT03871075 Recruiting - Clinical trials for Peripheral Artery Disease

Intermittent Pneumatic Compression With and Without Exercise to Improve Functioning in Peripheral Artery Disease

INTERCEDE
Start date: January 2, 2019
Phase: N/A
Study type: Interventional

The INTERCEDE randomized trial will establish whether six-months of intermittent pneumatic compression combined with walking exercise improves walking endurance at six-month follow-up, compared to walking exercise + sham compression therapy, in people with lower extremity peripheral artery disease (PAD). The INTERCEDE trial will also determine whether intermittent pneumatic compression therapy improves walking endurance at 6-month follow-up, compared to a sham compression therapy. The trial will also determine whether benefits of intermittent pneumatic compression persist after intermittent pneumatic compression treatment is completed.

NCT ID: NCT03791970 Recruiting - Clinical trials for Peripheral Artery Disease

Stents Post-dilation With DCB or POBA in Femoropopliteal Arteries

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

To compare the efficacy and safety of stent angioplasty with Orchid 035 Drug Coated Dilatation (DCB) and Plain Old Balloon Angioplasty (POBA) for post-dilatation for long (>10cm) femoropopliteal chronic total occlusion.

NCT ID: NCT03734549 Recruiting - Clinical trials for Peripheral Artery Disease

Predicting Procedural and Long-term Outcomes of Endovascular Revascularization for Lower Extremity Peripheral Artery Chronic Total Occlusions With Computed Tomographic Angiography

Start date: December 1, 2017
Phase:
Study type: Observational

Nearly one-half of all lower extremity percutaneous interventions performed in patients with symptomatic peripheral artery disease (PAD) involve chronic total occlusions (CTOs) which are technically more challenging and are associated with more periprocedural complications and lower rates of procedural success comparing with non CTOs. Despite innovate dedicated CTO devices developed and provides higher technical success, a wire-catheter approach to cross peripheral artery CTO is most often the first choice of operators as its lower cost advantage.Subhash Banerjee MD reported of all 1,362 CTOs, wire-catheter approaches were used in 82% and the technical success rate was 65%. If the operators chose wire-catheter as primary crossing device at the beginning of the procedure, but the technically failed with the provisional use of re-entry or crossing devices to try to procedural success. Such procedures add incrementally to procedure duration and cost and the revascularization and amputation rate at 12 month were highly increased comparing with using dedicated CTO devices initially. So it is very important to predict the outcome of guidewire crossing through CTOs to direct the choice of crossing strategy. Current data suggested that computed tomography angiography (CTA) imaging of PAD and a detailed comprehensive assessment for CTO arteries before endovascular therapy can assist preprocedural planning to maximize procedural success. Previous studies about coronary CTOs prediction scores as the KCCT score and CT-based CT-RECTOR provide the factors including occlusion length, the shape of proximal entry site, severe calcification, and etc. characters base on CTA correlating with the outcome of cross. As the same physiopathologic mechanism, we hypothesized that the radiographic characteristics are connected with outcomes of guidewire crossing occlusions. To our knowledge, few studies focused on how to predict the successful GC through peripheral artery CTO, therefore, the purpose of this study was to establish a simple and clinically applicable prediction model based on CTA characters within the occlusive lesions and clinical parameters to predict the GC outcomes of patients with lower extremity CTO. In addition, the long-term effect of endovascular revascularization are very important. An analysis concluded that limb adverse event (repeat revascularization rate 17.2%, amputation rates 8.5%) at 12-month in the CTOs with direct wire-catheter crossing strategy. Base on the proven influence factors (the lesion length, small diameter of the vessel and severe calcification, mechanical exposure, etc.)of adverse event at after endovascular revascularization ,we also can establish model with preoperative computer tomography angiography that provided the lesion detail characteristic combing the patients' biochemical and clinical feature to predict the adverse event rate at 12-month after endovascular revascularization.

NCT ID: NCT03686306 Recruiting - Clinical trials for Peripheral Artery Disease

VIRTUOSE : Efficiency of Sildenafil on the Absolute Claudication Distance of Peripheral Arterial Disease Patients With Intermittent Claudication.

VIRTUOSE
Start date: November 24, 2021
Phase: Phase 3
Study type: Interventional

Peripheral Arterial Disease (PAD) is a highly debilitating disease that affects 202 million people around the world and about 7 million people in France. Morbi-mortality from cardiovascular events is increased in this population. Intermittent claudication is defined as a discomfort and/or pain in the legs during walking. It is the most common clinical feature of PAD. In claudication, primary therapeutic approach is medical treatment and advice to walk. Revascularization is only proposed when medical treatment and advice to walk for at least 3 to 6 months have failed to improve symptoms and walking ability. Optimal medical treatment includes Antiplatelet, Lipid Lowering Drugs, AT2 antagonists / ACE Inhibitors and advice to walk. To date, no other drug has provided consistent evidence for functional improvement in claudication, except for Cilostazol, a type-3 phospho-diesterase inhibitor (PDEi). This compound has been scarcely used in France due to cost and frequent side effect (Headache, Flush, Diarrhea, etc.) and was withdrawn as a therapy in 2010. Sildenafil, a type 5 PDEi, is well tolerated, largely used in impotence and has interesting clinical delay and duration of action in the concept of a potential use in claudication. Preliminary data from the literature and unpublished case reports, suggest that this drug could efficiently improve symptoms and walking capacity in patients with stage 2 claudication.

NCT ID: NCT03668821 Recruiting - Clinical trials for Peripheral Artery Disease

Frailty in Vascular Patients Undergoing Surgery

Start date: January 1, 2021
Phase:
Study type: Observational

An observational cohort study of the frailty of vascular surgery patients undergoing intervention and their outcomes.

NCT ID: NCT03638115 Recruiting - Clinical trials for Peripheral Artery Disease

The VaSecure BTK Study

Start date: October 30, 2018
Phase: N/A
Study type: Interventional

To assess the safety and performance of the VaSecure drug-coated PTA balloon catheter in the treatment of patients with Chronic Limb Threatening Ischemia (CLTI) of the lower limb below the knee (BTK)

NCT ID: NCT03622359 Recruiting - Diabetes Mellitus Clinical Trials

Radiotracer-Based Perfusion Imaging of Patients With Peripheral Arterial Disease

Start date: February 17, 2017
Phase: N/A
Study type: Interventional

The aim of this clinical study is to 1) establish a healthy database for nuclear perfusion imaging of the lower extremities and 2) assess the prognostic value of radiotracer-based perfusion imaging for predicting clinical outcomes in patients with peripheral artery disease (PAD) who are undergoing lower extremity revascularization procedures. We hypothesize that radiotracer imaging of the lower extremities will provide a sensitive non-invasive imaging tool for quantifying regional abnormalities in skeletal muscle perfusion and evaluating responses to medical treatment.