View clinical trials related to Peripheral Arterial Disease.
Filter by:Prospective, multi-center, non-randomized clinical trial with follow-up investigations at 1, 6 and 12 months. To confirm safety and efficacy of Passeo-18 Lux DCB in new and non-stented re-stenotic lesions in the superficial femoral artery (SFA) and proximal popliteal artery (PPA) in a Chinese patient population.
To observe early safety and performance of the Shockwave Medical Lithoplasty® System (specifically, Lithoplasty® Catheters: 2.5 x 60mm, 2.75 x 60mm, 3.0 x 60mm, 3.25 x 60mm, and 3.5 x 60mm) in subjects to demonstrate that the Shockwave device can safely and effectively deliver localized pulsatile mechanical energy for balloon dilation of calcified, stenotic, infrapopliteal arteries.
AIMS: Determining the clinical features and prevalence of peripheral artery disease (PAD) in asymptomatics patients with type 1 diabetes mellitus (T1DM) and checking the validity of the current recommendations regarding for PAD screening in T1DM. METHODOLOGY: An observational and cross-sectional prevalence study. The whole group of patients (sample size calculated: 299 patients) will make the Edinburgh Questionnaire for detecting classic symptoms of intermittent claudication, and after verifying the absence of symptoms and exclusion criteria, they will be included in the study. All patients will undergo assessment of clinical parameters related to T1DM and classic cardiovascular risk factors, as well as, an analytical assessment of the lipid profile, HbA1c level, proinflammatory profile and oxidative stress status. They will also undergo a comprehensive anthropometric assessment including office blood pressure (BP) monitoring and ambulatory 24-hours BP monitoring in patients with an indication as routine clinical practice, assessment of cardioautonomic function, and lastly an ankle-brachial index (ABI) by Doppler ultrasound, in the context of routine clinical practice in patients with clinical indication, or as an extraordinary procedure for participating in the study in patients who do not meet criteria for screening according to current recommendations.
This study will determine whether an ankle foot orthosis (AFO) improves walking performance in patients with PAD from its first use. Additionally, the study will test walking performance after a three month AFO intervention and will examine the feasibility of this AFO intervention. Data for evaluations will be collected from 50 patients with PAD. Fifty healthy age-matched controls will be participate in one baseline gait assessment for comparison purposes. Both groups between 40-85 years old. Interventions and Evaluations Biomechanics evaluations: Patients with PAD will complete a biomechanics evaluation at baseline, following three months of control (standard of care), and following three months of AFO intervention. The evaluation will include measurement of walking distances, gait function, physical activity, quality of life, energy cost, muscle morphometrics, muscle activity, muscle oxygenation, and muscle strength and endurance while walking with and without the AFO. Healthy controls will be assessed during one baseline collection only and their participation in the study will then be finished. Feasibility interview: All patients with PAD will participate in feasibility interviews that will assess acceptability, demand, implementation, and practicality. Interviews will occur 1.5 months and following completion of the AFO intervention (not the control arm). AFO and Control (standard of care) Intervention: Patients will wear an off-the-shelf, carbon composite AFO that is adjusted to fit for three months. The patients will be asked to wear the AFO at all times except when they are in bed or showering/bathing. The instructions given to the patients about walking will be to follow the instructions from their doctor regarding risk factor management and exercise. The intervention order will be randomized and all subjects will participate in both arms.
The aim of the project is to investigate the clinical and patient centred outcomes of people with Peripheral Arterial Disease (PAD) attending a podiatry led integrated care pathway, utilising advice on diet, activity and smoking cessation. The podiatry clinic will be delivered from the Move More centre (NCSEM) and participants will be encouraged to access these facilities as part of their activity programme which will be agreed with the physical activity team. Primary and secondary outcomes will be clinical - claudication pain, distance walked at 3 and 6 months, blood pressure and lipid monitoring, weight management, reduced BMI, and the success of any smoking cessation. Quality of life and patient satisfaction with the programme will also be assessed.
The MIMICS-3D study will evaluate safety, effectiveness and device performance within a real-world clinical population of patients undergoing femoropopliteal intervention.
This study will evaluate how well Humacyte's Human Acellular Vessel (HAV) works when surgically implanted into a leg to improve blood flow in patients with peripheral arterial disease (PAD). This study will also evaluate how safe it is to use the HAV in this manner.
Whereas the efficacy of exercise interventions has been abundantly proven in male with peripheral artery disease (PAD), it remains to be determined whether these interventions are effective in women. The aim of this randomized controlled trial which will be performed with 34 PAD women will be to investigating the effects of 12 weeks of supervised walking on functional capacity and cardiovascular function and regulation at rest and during exercise.
This research project aims to investigate the gender-based difference in patients with peripheral artery disease. To attend this, this study has two specific objectives: Objective 1: To identify gender-specific barriers towards exercise and physical activity in patients with peripheral artery disease (PAD). Objective 2: To evaluate gender-specific differences in functional capacity and cardiovascular function and regulation in patients with PAD at rest, during and following a single session of maximal exercise.
This study represents an important step to validate the use of contrast-enhanced ultrasound (CEU) as a clinical research tool that can be used as a biologic readout of new therapies for Peripheral Artery Disease (PAD), and as a clinically-reasonable method for assessing impact of revascularization. The primary aim is to establish that CEU limb perfusion imaging can be used to accurately assess therapeutic improvements in tissue perfusion that are linked to symptom improvement.