Active clinical trials for "Peripheral Arterial Disease"

The purpose of this study is to assess the deliverability, clinical utility and effectiveness of the 5 mm diameter size offering of the LifeStent® Vascular Stent

Lower extremity peripheral arterial disease (LEPAD) is a highly prevalent chronic disease. Cardiovascular mortality of LEPAD patients at five years ranges between 18 to 30%. LEPAD is primarily caused by atherosclerosis that induces an inadequate blood flow to meet the tissues demand due to the narrowing of the arteries. An aggravation of the arterial lesions in LEPAD patients induces a worsening of patients' symptoms and a severe limitation of their walking capacity, contributing to an impairment of their quality of life. Despite maintaining a sufficient walking activity is essential for these patients, LEPAD patients lower their physical activity, which worsen the disease and potentially contribute to increase the risk of cardiovascular events and deaths. In a recent study in LEPAD patients, we showed, from a one hour GPS recording, a high variability of the patients' walking capacity (i.e., walking distances between two stops induced by lower limbs pain). Results suggested that in most patients previous stop duration before each walk was a predictor parameter of this walking variability. Whether there is an optimal or minimal recovery time influencing the walking capacity in LEPAD patients has never been studied. This study is a prospective, cross-sectional study in exercise pathophysiology. The main goal is to determine, following a walk that induces ischemia, the influence of the recovery duration on the subsequent walking performance in LEPAD patients. Secondary goals are : To determine the nature of the relationship between the recovery duration and subsequent walking performance. To study the relationship between exercise ischemia, pain evolution and previous recovery duration. To determine whether the experimental procedure influence the determination of an optimal of minimal recovery duration. To study the influence of recovery duration on walking capacity from community-based measurement.

This is a single-arm, single-center, open-label, pilot study . 30 subjects with foot symptoms attributable to diabetes or peripheral vascular disease will be screened . Subjects meeting inclusion criteria will sign informed consent and enrolled. All 30 subjects will be treated with the Magic Foot™. If there is any significant improvement in ICG or foot symptoms as obtained from self evaluation questionnaire, a further 30 subjects will be enrolled.

The genetic contribution and influence on the progression of peripheral artery disease (PAD) and possible cardiovascular events remains relatively unknown. As a result, the investigators are proposing for the creation of a registry of patients in the University of Pennsylvania Health System who are known to have PAD. The patients in this registry will be systematically monitored by conducting lower extremity ultrasound exams, ankle-brachial index (ABI) measurements, and six minute walk tests which have strong value in the positive diagnoses of PAD. These exams, combined with follow-up quality of life questionnaires, would allow for thorough monitoring of new diagnoses, symptoms, or serious adverse events. Blood will also be drawn looking for genetic biomarkers associated with this disease, which will provide further knowledge on the advancement and potential cardiovascular events associated with this disease. This blood will also be analyzed for components that will provide the investigators with knowledge of the patients overall blood vessel health. Micro RNA will also be evaluated to try to test if proteins and RNA in the blood can be used as predictors for future strokes or heart attacks. These exams will be repeated once annually over a duration of 10 years, with patients having hemodynamic monitoring as well as quality-of-life and cardiovascular events recorded at each visit. The data obtained from this registry will be compared to a created genetic profile looking for any genetic contribution to these new developments. Furthermore, this knowledge should offer impetus for physicians to target patients with these risk factors for the identification of potential adjustments to care.

The purpose of the BIOLUX P-III Spain registry is to further investigate the safety and clinical performance of the Passeo-18 Lux Drug Coated Balloon in the treatment of long atherosclerotic femoropoliteal artery lesions in daily clinical practice

This study evaluates the effects of Aspirin and thienopyridine resistance in relation to clinical cardiovascular outcomes as the genetic predictors of, and outcomes associated with aspirin and thienopyridine resistance in patients with peripheral arterial disease (PAD) currently remain unknown.

The Pedra Technologies' PedraTM device is a non-invasive, diagnostic device intended to measure foot perfusion by assessing blood flow. The PedraTM device comprises a compact instrument console connected to a sensor that is pasted onto the patient's foot during perfusion assessment. Through skin contact, the device is able to monitor tissue perfusion at depths of up to 7.5mm. The monitor console contains opto-electronic instrumentation including coherent infrared light sources, photo detectors, and display/control electronics. The sensor comprises passive fiber-optic conduits, which transfer infrared light from the console to the patient, and relays scattered light from the patient back to the console. The intensity of light emitted from the sensor is less than 3 mW, well within the safety envelope of Class I laser systems and comparable (or lower than) other commercially available devices such as laser Doppler systems. The sole point of contact with the patient is a layer of medical grade adhesive tape, which is used to paste the flat sensor onto intact skin.

This clinical investigation is intended to evaluate the ability of a magnetic cardiac positioning system to decrease medical radiation exposure on a peripheral angioplasty procedure in patients with a peripheral artery stenosis.

This two-year pilot study will test whether a one-page "Jumpstart Form" will affect goals-of-care discussions in the hospital. This form will be provided to clinicians and will include patient-specific information about preferences for goals-of-care communication and for care, as well as tips to improve this communication. Jumpstart forms will also be provided to patients or, if they are unable to communicate, their surrogates/family members. The information on the form will be obtained from questionnaires. The form is tailored to help patients and surrogates talk with clinicians about goals of care. This study is based on a successful application of Jumpstart Form in the outpatient clinic setting.

The objective of this study is to evaluate acute clinical results of orbital atherectomy (OA) via radial artery access, including complication rates and cost effectiveness.