View clinical trials related to Peripheral Arterial Disease.
Filter by:The objective of this study is to evaluate the safety and effectiveness of the TurboHawk for the treatment of peripheral arterial disease (PAD) in the superficial femoral and/or the popliteal arteries with the Japanese population.
Primary purpose of the Mimics Study is to evaluate the safety and performance of the BioMimics 3D Stent System in the treatment of symptomatic SFA/proximal popliteal disease.
This study is intended to collect safety and effectiveness data on the Cook Injectable Small Intestinal Submucosa (SIS)
The purpose of this pivotal, first in man study will be to evaluate safety and efficacy of the novel, microcrystalline paclitaxel coated balloon (mcPCB, PAK, Balton) in the treatment of femoropopliteal artery disease.
The investigators use MRI and/or CT to evaluate the extent, as well as, the structure, composition, and functional aspects of atherosclerotic plaques in human carotid and femoral arteries in patients scheduled to undergo an endarterectomy of the aforementioned vascular beds as part of their routine clinical care.
The purpose of this study is to determine whether DEB is more effective than common PTA balloon using under in long-term vessel patency and inhibiting restenosis in the infrapopliteal artery.
This is a multi-center, randomized, blinded, placebo controlled study to evaluate the safety of GSK1278863 and its acute and short-term (e.g. 14d) effects on calf muscle endurance and walking ability in subjects with PAD and symptomatic claudication.
Background - In patients with critical limb ischaemia (CLI), the infragenicular arteries are often involved. Without revascularisation, amputation often is imperative. There is a high technical success rate of endovascular revascularisation of infragenicular arteries with percutaneous transluminal angioplasty (PTA), but mid- and long-term results are disappointing as restenosis frequently occurs. Drug-eluting balloon (DEB) PTA has been shown to improve patency rates after PTA of coronary arteries. Aim - To study the results of DEB-PTA compared to conventional balloon CB-PTA for the treatment of infragenicular lesions in patients with CLI. - To evaluate cost-effectiveness of DEB-PTA versus CB-PTA in patients with critical limb ischemia (CLI) by quantifying the incremental cost-effectiveness ratio (ICER). Hypothesis - DEB PTA results in improved patency rates compared to CB-PTA for treatment of infragenicular arterial lesions in patients with CLI. - DEB-PTA is a cost-effective strategy in patients with CLI compared with CB-PTA. Methodology Multi-center, prospective, randomised parallel-group trial. Patients are eligible for enrolment if they have CLI and at least one infragenicular lesion with a maximal total lesion length of 20cm. Randomisation will be performed on a 1:1 ratio to either DEB-PTA or CB-PTA. Patients will be assessed prior and directly after the intervention, at 3, 6 and 12 months by Rutherford classification, ankle-brachial index, toe pressure and adverse events. Duplex will be performed at 3 months. Angiography will be performed before and directly after PTA and at 6 months. Primary end-point will be primary patency of the treated lesions at 6 months on angiography (defined as <50% stenosis, without re-intervention in the interim). Secondary end-points are limb salvage at 3, 6 and 12 months, primary patency of the treated lesion on Duplex at 3 months (defined as patency of the treated artery with peak systolic velocity (PSV) ≤2.0 m/sec), Rutherford classification, minor and major amputation, infrapopliteal endovascular re-intervention, patency of treated femoropopliteal sites (if applicable), infrapopliteal surgical bypass, peri-procedural complications and death at 3, 6 and 12 months. A cost-effectiveness analysis (CEA) from a societal perspective will be performed in parallel with the randomized clinical trial with a 12-month time horizon.
This first-in-man study is to evaluate the Drug-Coated Chocolate (DCC) Balloon for percutaneous arterial angioplasty in patients with symptomatic peripheral arterial disease. The study focuses on acute device performance and peri-procedural safety and also seeks to further characterize the performance of the device.
Clopidogrel besylate (CB) is not differentiated relative to the orignal clopidogrel hydrogen sulfate (CHS) in the pharmacokinetics and in antiplatelet potency in healthy volunteers. In addition,CB exhibits similar pharmacodynamic properties compared to CHS in patients with a history of acute coronary syndrome (ACS) and in patients with ACS undergoing percutaneous coronary intervention (PCI). However, there is a lack of data on the clinical efficacy and safety of this salt to the original salt in patients with cardiovascular disease. The aim of this study is to investigate the clinical efficacy and safety of CB in relation to that of CHS in patients eligible to receive clopidogrel.