Active clinical trials for "Peripheral Vascular Diseases"

Two hundred patients evaluated to undergo revascularization (elective/emergent, surgical/interventional) for lower limb PAD at the cantonal hospital of Aarau, Switzerland, will, after consenting to participate in the study, be asked to fill up both SF-36 and VascuQol-6 questionnaires while sitting in a waiting room before the procedure and during the 30 days and 1-year routine follow up. An electronic version of the questionnaires will be administered on a tablet. The primary goal is to validate the clinical use of the German electronic version of the VascuQol-6 questionnaire to assess patient-related outcomes of the performed treatment by patients with PAD.

BALT has designed an electronic platform to continue collecting clinical data as part of the post-marketing clinical follow-up of its devices. This platform is purely exploratory, without hierarchical order of the objectives and associated outcomes.

This multicenter, single-arm retrospective registry (chart review) is being conducted to confirm the clinical performance and safety of GORE-TEX® Vascular Grafts and GORE® PROPATEN® Vascular Graft throughout the device functional lifetime for each indication area.

The investigators will evaluate a potentially faster and more clinically feasible method to optimize exoskeletons in pilot tests in healthy in preparation for patients with peripheral artery disease.

Background Peripheral arterial disease (PAD) and its relevant complications are more common in hemodialysis (HD) patients. The potential association regarding chronic kidney disease dysbiosis, inflammation and metabolic endotoxinemia in HD patients is unknown. A cross-sectional study will be carried out the evaluate the possible association endotoxin core antibody with asymptomatic PAD in a cohort of HD patients. Methods This cohort study enrolled 500 HD patients treated at a single center in Taichung city. Fasting blood samples will be collected to determine biochemical data Endotoxin core antibody levels and other related biomarkers. By the automatic oscillometric method, the ankle-brachial index (ABI) was measured. Low ABI was defined as any value < 0.9.

The goal of this observational, practice-based feasibility study is to observe the efficacy and safety of intramuscular administration of Stempeucel® in Malaysian patients with critical limb ischemia (CLI) due to peripheral arterial disease. The main questions it aims to answer are: Can intramuscular administration of Stempeucel® reduce symptoms of CLI due to peripheral arterial disease while improving the healing rate and functional outcomes? Does intramuscular administration of Stempeucel® causes any serious adverse events in CLI due to peripheral arterial disease patients? Study patients will be assessed by the PI before administering the Stempeucel® for any other organ with inflammation. The study patients will also be followed up to the duration of 1 year after study treatment administration for safety and efficacy assessment.

CURRENT Registry is a physician-initiated prospective, multicenter, post-market, single-arm study with a plan to include approximately 100 patients eligible to be treated with RenzanTM Peripheral Stent System.

Klotho, a membrane-bound protein co-receptor for fibroblast growth factor 23 (FGF23), is involved in atherosclerotic process and cardiovascular diseases. It regulates blood glucose and cholesterol levels. In addition, the lack of klotho has been associated with endothelial dysfunction, calcification and accumulation of cholesterol in the arteries, leading to coronary heart disease. The goal of this observational study is to evaluate the potential use of circulating klotho and FGF23 serum levels as biomarkers of major adverse limb events (MALE) and major adverse cardiovascular events (MACE) in patients with peripheral artery disease (PAD) and chronic limb threatening ischemia (CLTI) requiring a procedure of endovascular revascularization. The main questions it aims to answer are: association between klotho and FGF23 serum levels and major adverse limb events (MALE) after lower extremity revascularization. association between klotho and FGF23 serum levels and major adverse cardiovascular events (MACE) after lower extremity revascularization. Patients with PAD and CLTI requiring lower extremity endovascular revascularization will undergo blood sampling for the dosage of circulating klotho and FGF23 before the endovascular procedure. Incidence of MACE and MALE will be collected in a 12-months follow-up and will be associated with klotho and FGF23 serum levels at baseline.

Peripheral arterial disease (PAD) due to atherosclerotic narrowing of arteries of the lower limb is common and associated with increased cardiovascular mortality and morbidity. The prevalence of PAD increases with age affecting approximately 10% of population age >60 years and nearly 50% age >85 years. However, the awareness of PAD is poor with less than 5% of patients with PAD aware of their condition; and the condition is often underdiagnosed and undertreated. Clinical diagnosis of PAD can be difficult because up to 50% of patients do not complain of overt symptoms such as intermittent claudication (IC) and critical limb ischemia (CLI). The prognosis of patients with PAD is not benign irrespective of symptoms. Atherosclerosis is a systemic disease where 30% to 50% of patients with PAD have concomitant coronary artery disease (CAD) and cerebrovascular disease (CVD) and they share common risk factors including diabetes mellitus, hyperlipidemia and hypertension. In the multi-national REACH registry, 1 in 5 patients with PAD experienced CV death, MI, stroke, or hospitalization within 1 year which is even higher than patients with CAD or CVD. Screening may increase early detection of PAD and provide opportunity to identify concomitant CV diseases and/or risk factors, earlier treatment and hence reduction. in adverse CV events. However, there is lack of an accurate and cost-effective assessment tool for PAD screening. Resting Ankle-Brachial Index (ABI) which measures the difference in blood pressure between the arm and the ankle as a ratio is the most widely used method to diagnose PAD. An ABI <0.9 is diagnostic of obstructive lower limb PAD with sensitivity of 97% and a specificity of 80-100%. ABI performed with exercise (i.e. exercise ABI) has been shown to increase the diagnostic yield of resting ABI when the clinical suspicion for PAD is high and the resting ABI is normal. Exercise is usually performed with a treadmill or active pedal plantar-flexion (APP) when patient is unable to walk on the treadmill. Resting and exercise ABI measurement can be performed in an outpatient setting but is time consuming, and requires technical training and special equipment such as Doppler ultrasonic velocity signal probe which is not readily available in the primary care setting. This has led to under-utilization of ABI for the diagnosis of PAD despite strong guideline recommendations and unsuitable as a screening tool in the primary care setting. Other diagnostic tests for PAD such as duplex ultrasound, magnetic resonance or computed tomography angiography are even less readily accessible, costly and can potentially causes harm to patients in the form of radiation and contrast reaction. Questionnaires such as the Rose Questionnaire or Edinburgh Questionnaire have been validated to identify PAD patients with claudication symptoms. Although these questionnaires have high specificity of >90%, their sensitivity is much lower at 20-30%.They are also time consuming to administer at scale in the outpatient setting. Therefore, questionnaires alone are not widely adopted for PAD screening in the primary care setting. Recently, a single claudication question has been proposed as a simpler and easier to administer screening tool for PAD which has high specificity but is also limited by low sensitivity.Therefore, there is an unmet clinical need for an alternative assessment tool for PAD screening that is more sensitive than currently available claudication questionnaires and can be easily administered in the primary care setting. In this study, we aim to evaluate the diagnostic accuracy of a novel assessment tool consisting of a single claudication question combined with symptom-limited APP test in detection of PAD using resting and/or exercise ABI as the reference. This screening tool is simple to use and has the potential to be self administered without supervision whereby reducing time and costs of screening.

The objective of this early feasibility study is to assess the safety and performance of the BD™ Sirolimus Drug Coated Balloon Catheter.