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Peripheral Arterial Disease clinical trials

View clinical trials related to Peripheral Arterial Disease.

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NCT ID: NCT04800276 Recruiting - Clinical trials for Peripheral Arterial Disease

Adapted Physical Activity in Patients With Lower Limb Peripheral Arterial Disease

ACTIV'AO
Start date: February 1, 2021
Phase: N/A
Study type: Interventional

The prevalence of peripheral arterial disease is 12.2% in France. Intermittent claudication is the most common symtom of this disease. During physical exercise, such as walking, blood oxygen (O2) requirements increase. The development of atherosclerosis in the lower limbs, causes narrowing of the arteries and limits the increase in blood flow required for muscular effort. Patients then experience muscle pain, the intensity of which gradually increases until it forces them to stop. After stopping, the pain subsides and disappears in less than 10 minutes. The location of the pain (calves and/or thighs and/or buttocks) is related to the location of the ischemia (distal in the calf, proximal in the thigh or buttock, or proximo-distal if several locations). This can have different consequences on the biomechanical parameters of walking and muscle activity. To date, the impact of this localization on physical capacity has never been studied. These limitations are very disabling and impact the quality of life of patients. In addition, poor lower limb performance is associated with higher mortality. Reducing symptomatology and improving functional abilities is therefore a major issue in patients with peripheral arterial disease. This can be achieved through the practice of an Adapted Physical Activity, an essential recommendation in the care of patients with peripheral arterial disease. Our main hypothesis is that the physical activity rehabilitation protocol "Activ'AO" will improve the functional capacities of patients with peripheral arterial disease who have followed the program with the localization of ischemia with a greater consideration than in patients in the group following a "standard" APA protocol. Improvements in functional abilities (such as walking) will lead to improvements in quality of life.

NCT ID: NCT04794530 Recruiting - Clinical trials for Peripheral Artery Disease

The COCOA-PAD II Trial

COCOA-PAD II
Start date: November 19, 2021
Phase: Phase 3
Study type: Interventional

Among people with peripheral artery disease (PAD) age 55 and older, the investigators will test the hypothesis that PAD participants randomized to cocoa flavanols will have greater improvement or less decline in six-minute walk distance at six-month follow-up, compared to those randomized to placebo. The study will randomize 190 participants with PAD age 55 and older to one of two groups for six months: cocoa flavanols vs placebo. Our primary outcome is change in six-minute walk distance at six-month follow-up. Secondary outcomes are Actigraph-measured physical activity, brachial artery flow-mediated dilation (FMD), gastrocnemius muscle biopsy measures of endothelial nitric oxide synthase (eNOS) and phosphorylated eNOS, gastrocnemius muscle perfusion (measured by magnetic resonance imaging (MRI)) and gastrocnemius muscle characteristics (measured by muscle biopsy). To achieve the specific aims, the study will randomize 190 participants age 55 and older with PAD to one of two groups: cocoa flavanols vs placebo. Participants will be followed for six months.

NCT ID: NCT04793581 Recruiting - Clinical trials for Peripheral Arterial Disease

Assessment of the Utility of the Pantheris Small Vessel (SV) System

Start date: January 29, 2021
Phase: N/A
Study type: Interventional

A single-arm study to assess the utility of the Pantheris SV catheter in addressing peripheral artery disease in arteries located below the knee. Data will be collected on the percent stenosis pre- and post-atherectomy and then symptoms and adverse events noted at 30 days, 6 months, and 1 year after the procedure.

NCT ID: NCT04792320 Recruiting - CKD Clinical Trials

Oral Absorbent and Probiotics in CKD Patients With PAD on Gut Microbiota, IncRNA, Metabolome, and Vascular Function

Start date: June 19, 2020
Phase: N/A
Study type: Interventional

Taiwan has more chronic kidney disease (CKD) per capita than anywhere in the world, leading to the highest expense of National Health Insurance. By reviewing previous studies, uremic toxins contribute critically to the detrimental effects of CKD on atherosclerotic peripheral artery disease (PAD). When recognized early and managed appropriately, mortality and complications of the participants with CKD and established PAD can be minimized. It is critical to identify novel biomarkers and mediators, which can help identify those with potential poor outcomes and facilitate the discovery/development of novel therapeutics for the patients with CKD and PAD. The OMICs studies support the theory that gut microbiome is a major contributor to adverse cardiovascular outcomes and progression of CKD. However, successful integration of multi-omics approach remains sparse. There is no report on the impact of gut microbiota on the host circulating long non-coding RNAs (lncRNAs) expression signature, other CAD/PAD potential marker, and the potential link between gut microbiota, circulating lncRNA levels changes and CKD/PAD. Additionally, although numerous studies indicated that probiotics or activated charcoal have benefits for CKD patients, few studies evaluated the effect of coadministration of activated charcoal/probiotics on the patients with CKD/PAD. The mechanisms of therapeutic effect on CKD/PAD patients with coadministration of activated charcoal/probiotics involving the cross talk among host, microbiota and metabolites still remain unclear. Thus, in the present study, investigators aim to develop novel diagnostic/prognostic markers and a new treatment with activated bamboo charcoal (ABC)/probiotics for therapeutic opportunities to prevent cardiovascular complications, amputation and death in CKD patients with established PAD. To identify the diagnostic/prognostic markers, the multi-omics (microbolome and metabolome) and lncRNA will be analyzed. The therapeutic impact of activated bamboo charcoal (ABC)/probiotics with optimal formulation, on the renal/endothelial/vascular function, cardiovascular (CV) outcome and mortality in CKD patients with PAD will be also determined to evaluate its therapeutic opportunities.

NCT ID: NCT04787770 Completed - Clinical trials for Peripheral Arterial Disease

The Role of HSP90 in Peripheral Vascular Lesions of Diabetic Atherosclerosis

rhsppvlda
Start date: September 1, 2020
Phase:
Study type: Observational

Diabetic foot disease with a global incidence of about 6% is one of the most serious complications of diabetes, which brings great pain and economic burden to patients.In China, the incidence rate is 8.1%, and the amputation rate is 7.3%. Every year, more than 1 million diabetic patients have amputations, ranking first among non-traumatic amputations.According to the American Diabetes Association (ADA), the incidence of Peripheral Arterial Disease (PAD) in diabetic patients is twice that of non-diabetic patients, and the resulting lower limb ischemia is the main cause of the high mortality and disability rate of diabetic foot.According to the International Working Group on Diabetic Foot (IWGDF), about 50% patients with diabetic foot disease are complicated with PAD, and the degree of vascular stenosis is closely related to the prognosis.Severe limb ischemia is a higher cause of diabetic foot ulcer in China than in western countries.Atherosclerosis is the main pathological change of diabetic peripheral artery disease, and endothelial injury is the initial link of atherosclerosis.Heat shock protein 90 (HSP90) is a kind of important heat stress protein, which accounts for about 2-3% of the total protein in cells.It is involved in the correct folding and activation of intracellular proteins.Although Hsp90 is primarily involved in intracellular protective mechanisms, they can also be exposed to the plasma membrane and released in the extracellular space, resulting in detectable levels of Hsp90 in the blood.Extracellular heat shock proteins are involved in cell-cell communication as well as immune and inflammatory processes.Hsp90 promotes cell survival, migration, inflammation and angiogenesis, and is therefore considered a promising target for cancer therapy.This led to the development of specific HSP90 inhibitors.More recently, these inhibitors have also been tested in diabetic animals.The use of the HSP90 inhibitor 17-DMAG significantly reduced atherosclerotic lesions and induced a more stable plaque phenotype in a mouse model with hyperglycemia and hyperlipidemia.Hsp90 is upregulated in human carotid atherosclerotic plaques (especially in unstable areas of plaques) and in patients' serums, triggering autoimmune antibodies against Hsp90 in patients.Is HSP90 also present in serum of patients with diabetic peripheral arterial disease?Is there a relationship between secretory heat shock protein 90 and arterial disease?The study that HSP90 may be involved in the molecular mechanism of vascular endothelial barrier function impairment in diabetes will provide a new target for the early serological diagnosis and treatment of diabetic vascular disease.The aim of this study was to investigate the relationship between the degree of vascular disease and serum heat shock protein 90 in patients with type 2 diabetes.The study was divided into three groups: diabetic without PAD group, diabetic with PAD group and diabetic foot group.According to the degree of peripheral artery disease, the patients were divided into three groups, and the content of heat shock protein 90 in serum of the patients was detected.To analyze the correlation between the degree of peripheral arterial disease and the content of heat shock protein 90 in serum.

NCT ID: NCT04776434 Active, not recruiting - Clinical trials for Peripheral Artery Disease

SUCCESS (SelUtion, Safety, effiCaCy, hEalth economicS and promS) PTA Study

SUCCESS PTA
Start date: February 8, 2021
Phase: N/A
Study type: Interventional

Open label, real-world, prospective, multi-center, single arm, post-market surveillance study of the SELUTION SLR™ (Sustained Limus Release) drug eluting balloon (DEB).

NCT ID: NCT04774159 Recruiting - Inflammation Clinical Trials

Low Dose ColchicinE in pAtients With Peripheral Artery DiseasE to Address Residual Vascular Risk

LEADER-PAD
Start date: May 6, 2021
Phase: Phase 3
Study type: Interventional

The Low dose ColchicinE in pAtients with peripheral Artery DiseasE to address residual vascular Risk (LEADER-PAD) trial will evaluate if anti-inflammatory therapy with colchicine will reduce vascular events in patients with symptomatic peripheral artery disease.

NCT ID: NCT04772300 Recruiting - Clinical trials for Peripheral Artery Disease

Trial to Assess the Safety and Efficacy of Sirolimus-Coated Balloon vs. Uncoated Standard Angioplasty for the Treatment of Below-the-knee Peripheral Arterial Disease

LIMES
Start date: February 10, 2022
Phase: N/A
Study type: Interventional

This study is a prospective, interventional, multicenter 1:1 randomized trial. The trial evaluates the safety and efficacy of the Magic Touch PTA sirolimus drug-coated balloon in comparison to the treatment with POBA (control device) in patients with advanced infrapopliteal artery disease.

NCT ID: NCT04765566 Completed - Clinical trials for Vascular Diseases, Peripheral

FLUENCY® PLUS in the Treatment of Peripheral Artery Disease

Start date: February 5, 2021
Phase:
Study type: Observational

This is a retrospective, multi-center study to assess the safety and performance by proactively reviewing pre-existing medical records and imaging of patients who had previous placement of FLUENCY® PLUS Vascular Stent Graft in iliac artery vessel(s) between January 2010 and March 2020.

NCT ID: NCT04755335 Enrolling by invitation - Clinical trials for Peripheral Arterial Disease

Ultrasonic Perfusion Estimation in Calf Muscle

Start date: February 28, 2020
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the potential of ultrasound perfusion imaging technique for assessing the progression of peripheral arterial disease (PAD) and monitoring its response to therapy by measuring changes in microvessel alterations and perfusion variations.