Active clinical trials for "Peripheral Vascular Diseases"

Unifusol (R) is a solution of arginine sodium succinate for intravenous infusions. Its effects include vasodilation, protection of inner layer of blood vessels and improvement of blood viscosity. The present phase I study is aimed to evaluate the safety and tolerability of Unifusol infusions in healthy volunteers.

To evaluate the benefits of Ayurvedic SUVED & REIMMUGEN Colostrum for reduction/reversal of symptoms and study clinical progress in Vascular disease; CAD, CAV, Stroke, DVT patients.

In this controlled trial, patients with peripheral arterial disease will be randomized to either maximal walking, submaximal walking, or usual care groups.

This study will assess the adjuvant benefit of a neuromuscular electrical stimulation device to standard treatment of supervised exercise in patients suffering from symptoms and effects of lower limb Intermittent Claudication.

Shockwave Medical, Inc. intends to conduct a prospective, single-arm, multi-center, clinical study designed to evaluate the safety and performance of the Shockwave Lithoplasty™ System in subjects with moderate to heavily calcified peripheral arteries with 3.50mm to 7.0mm reference vessel diameter at the target site. The Shockwave Lithoplasty™ System is indicated to generate sonic shockwave energy within the target treatment site and disrupt calcium within the lesion to allow for subsequent dilation of a peripheral artery stenosis using low balloon pressure. Up to sixty (60) subjects will be enrolled and treated with Lithoplasty to yield thirty (51) evaluable subjects complete the study assuming a 15% lost to follow-up rate.

Peripheral arterial disease (PAD) due to lower limb arterial blockages affects significant proportion of the population with an age-adjusted prevalence of approximately 12%. Claudication induced walking impairment can be debilitating and adversely affects social, leisure, and occupational activities in many patients and is associated with higher mortality among PAD patients. Unfortunately, very few effective therapies are available to improve leg symptoms and exercise performance in PAD patients. Surgery is the last resort but results vary. Therefore, there is a large unmet need for medical therapies that can improve long-term walking performance and functional capacity in PAD patients. Danshen and Gegen (D&G) are commonly used Chinese herbal medicine in the treatment of cardiovascular diseases. D&G study has been extensively researched and continued at The Chinese University of Hong Kong (CUHK) for their antioxidative and vasodilator properties, modulate anti-atherosclerosis and improve arthrogenic athophysiology. Three randomized trials were completed at the CUHK showing D&G improved lipid profile, vascular function and thinned down the internal layer of the carotid artery. One may expect the same with lower limb arteries. Extensive clinical experiences of use in China and Hong Kong indicated that D&G are well tolerated and safe. This project is a randomized control trial to determine the efficacy and Safety of D&G in improving the functional capacity & QoL in patients with symptomatic PAD. The results of this study have the potential to change local and international practice in providing a much needed therapeutic option in the treatment of PAD.

The primary objective of the VBX13-05 clinical study is to evaluate the safety and efficacy of VIABAHN BX for the treatment of arterial occlusive disease in patients with de novo or restenotic lesions in the common and/or external iliac arteries.

The number and function of circulating endothelial progenitor cells (EPCs) are inversely associated with coronary risk factors and atherosclerotic diseases such as PAOD. This double-blind, randomized, placebo-controlled trial to evaluate the effects of cilostazol on human early EPCs and angiogenesis as well as the potential mechanisms of action in patients with mild-to-moderate PAOD.

This study is intended to collect safety and effectiveness data on the Cook Injectable Small Intestinal Submucosa (SIS)

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.