View clinical trials related to Peripheral Arterial Disease.
Filter by:Background: Lower limb arterial revascularization procedures, either percutaneously or surgically performed, are an established treatment modality of ischemic foot ulcers, especially in the setting of a critical limb ischemia. Many other lower limb ulcers are secondary to a combined disease, which may include a concomitant venous disease (chronic venous insufficiency or varicous disease) or a micro-angiopathic disease (i.e. small vessel disease). In this setting, and especially in the absence of a concomitant severe macro-angiopathic disease, the safety and efficacy of a percutaneous lower limb revascularization have so far never been evaluated in a prospective study. Aim: This study is aimed to evaluate the safety and the efficacy of an endovascular revascularization approach of the lower limb, in all consecutive patients presenting with a non-healing ulcer associated with a mild to moderate peripheral artery disease (i.e. mixed-origin ulcers). Material and methods: This prospective study will consecutively include all patients presenting with a non-healing ulcer. Included patients must have all the concomitant ulcer co-factors being adequately treated for at least 6 months. Accordingly, an underlying venous disease, infectious disease or inflammatory disorder must be previously evaluated and adequately treated (i.e. compression stocking, varices stripping, antibiotics, local ± systemic anti-inflammatory, etc.). Furthermore, a non-invasive arterial evaluation must be obtained in all patients. The arterial screening must included an ankle-brachial index (ABI) and toe pressure (TP) measurements, a trans-cutaneous oxygen measurement (tcPO2) at the foot and calf levels and a non-invasive arterial mapping (i.e. angio-CT or angio-MRI). This arterial work-up must be compatible with the presence of a mild to moderate peripheral artery disease without any sign or criteria suggesting the presence of a critical limb ischemia. End-points: The success rate of perform an endovascular revascularization intervention in all consecutive patients which qualify according to the inclusion criteria (technical feasibility). Establish the proportion of procedural related complications (safety). Analyze the clinical and the para-clinical improvements in term of heal of the ulcers, as well as the improvement of the ABI, TP, tcPO2 at 1 week, 1-3-6 months after the procedure (efficacy). Sample size: The investigators plan to include ≈ 30 patients in two years. After 1 year of enrollment the investigators will perform an interim analysis and will decide at that moment, according to the observed end-points, if prolonging the study would be of any scientific value or if the study has to be interrupt earlier because of a significant improvement of all already treated ulcers.
The peripheral arterial disease (PAD) is a common atherosclerotic disease manifestation and its prevalence increase with age and with the simultaneous presence of cardiovascular risk factors. PAD patients are usually treated, as a first line treatment, with the exercise therapy, combined with the pharmacological antiplatelet therapy. In the case of first line therapy failure, PAD patients usually undergoing to invasive revascularization procedures. After a peripheral stent has been located, the major follow-up problem is the restenosis rate. Published studies describe how, in a large amount of patients, can be recognised an high residual platelet activity. These data about PAD patients at the moment are lacking . The authors would evaluate the incidence of PAD patients with an high residual platelet activity.
The purpose of this study is to assess the safety and efficacy of administering intra-arterial paclitaxel in the femoropopliteal arteries via the TAPAS catheter following percutaneous revascularization to prevent restenosis.
The medical device "Vascular Join" represents a new anastomotic technology that should reduce the inter-surgeons variability in anastomosis construction and increase the performances in terms of results. It allows a perfect mechanical anastomosis without suture, avoiding the disadvantages of operation length and difficulty of the act, thrombosis, clamping and embolism. The "Vascular Join" creates automatically the connection between the vein or prosthesis at both ends and bridging the artery while preventing the passage of the needle and suture through the vessel wall and clamping pressure. This makes it very easy to construct a vascular anastomosis using the endoscopic technique less traumatic for the patient, lessen the pain of the patient, thereby reducing health care costs by reducing the length of hospital stay. No part of the device is in contact with the patient's blood because the whole system remains in the thickness of the arterial wall and outside the vessel. Thus, the formation of intimal hyperplasia is greatly diminished and the risk of occlusion of the anastomosis is less than the currently available risk when a suture is used. This risk is shown by studies on animals in labs, with a mean follow up of 12 months. The Vascular Join creates a perfect congruence of anastomosed vessels because it allows a perfect match between each vascular tunic. The medical device Vascular Join has been designed in order to: - Reduce the suture time; - Reduce the risk of occlusion of vein after the surgical process; - Avoid the contact risk between the external material steel (surgical needle) and blood; - Standardize the quality of anastomoses independently of the skill of the surgeon.
The purpose of this study is to evaluate safety and performance of the balloon-expandable Zeus CC (Rontis AG) stent for the treatment of Trans-Atlantic Inter-Society Consensus (TASC) A, B, C and D iliac lesions.
The purpose of this study is to test and validate a new questionnaire in order to get a "walking estimated limitation calculated by history (WELCH) in patients referred for vascular investigations.
Prospective monocenter single-blind randomized (1:1) investigator sponsored clinical trial, in which consecutive patients candidates for percutaneous intervention of angioplasty to treat symptomatic in-stent restenosis of the SFA and P1 segment of the popliteal artery will be assigned to one of two study arms: 1. Treatment Arm: Paclitaxel eluting percutaneous transluminal angioplasty (PePTA) 2. Control Arm: standard percutaneous transluminal angioplasty (sPTA). Purpose: To evaluate the morphologic and clinical efficacy of Paclitaxel eluting percutaneous transluminal angioplasty (PePTA) for the reduction of restenosis in SFA and PA stents compared to standard percutaneous transluminal angioplasty (sPTA).
Specific Aim 1: To test the hypothesis that subjects with PAD and intermittent claudication have altered expression of genes that regulate skeletal muscle metabolism. Specific Aim 2: To test the hypothesis that exercise training improves calf skeletal muscle insulin resistance and genes that regulate skeletal muscle metabolic function in PAD patients with intermittent claudication.
This study is designed to test two hypotheses: 1. The PADnet+ testing system produces clinically equivalent results as the Parks Flo-Lab testing system in a group of patients referred for evaluation of PAD of the limbs when performed by a Registered Vascular Technologist (RVT). 2. The PADnet+ testing system produces clinically equivalent results when the testing is repeated on the above patients and performed by staff specifically trained on the use of the PADnet+ system but are not vascular technologists nor hold the RVT certification.
The prevalence of peripheral artery disease (PAD) defined as ankle-brachial index (ABI) less than 0.9 was about 15~30% in patients with end stage renal disease (ESRD), which was higher than those with normal renal function. A lower ABI and a higher brachial-ankle pulse wave velocity (baPWV) are good markers to predict the risk of PAD and atherosclerosis respectively. In addition, baPWV>2,100 cm/s was shown to be related to potential PAD. ABI <0.9 was positively associated with vascular access failure in hemodialysis (HD) patients and our previous study has demonstrated that far infrared (FIR) therapy can improve access flow and unassisted patency of atrioventricular (AV) fistula. The aims of this study are to evaluate (1) the frequency of and (2) risk factors associated with abnormal ABI and PWV as well as (3) the effect of FIR on ABI and PWV and markers related to endothelial dysfunction in HD patients.