L-Citrulline in Peripheral Artery Disease
Peripheral Arterial DiseaseSome studies have reported improved vascular function with the supplementation of L-arginine in participants with cardiovascular disease (CVD). Several clinical studies have also begun the investigation of L-arginine supplementation in participants with peripheral artery disease (PAD). This is particularly important as currently there are limited options available to medically manage intermittent leg pain resulted from PAD. Although some of these short-term clinical trials suggested that oral L-arginine improved walking distance or improved walking speed in participants with PAD, these results were not consistent. Further, only 1% of the oral supplemented L-arginine is available for the NO production as the rest is metabolised by the body. A better way to provide the body with substrate to produce NO is therefore needed. The natural amino acid and food component, L-citrulline has been suggested to be a good candidate for this purpose. L-citrulline, named after watermelon citrullus vulgaris from which it was first isolated, is a natural precursor of L-arginine. Studies have shown that L-citrulline is metabolised by the body to a lesser degree compared to L-arginine and hence is an effective precursor of arginine in peripheral tissues, including endothelial cells. Oral L-citrulline supplementation also eliminates some of the unwanted effects associated with oral arginine supplementation and it is well tolerated without known side effects. In addition, L-citrulline is a supplement that is available over-the-counter. Thus, oral supplementation of L-citrulline may be a new intervention strategy in participants with PAD. The investigators hypothesize that the oral food supplement L-citrulline, unlike L-arginine, reverses endothelial dysfunction. In a multinational, multicenter, double blinded, randomised, placebo-controlled cross-over trial the effects of L-citrulline in peripheral artery disease will be investigated.
Safety and Feasibility of SurModics SurVeil (TM) Drug Coated Balloon
Peripheral Arterial DiseasePeripheral Vascular DiseasesPREVEIL is a prospective, multi-center, single-arm clinical trial to assess the safety and functionality of the SurModics drug coated balloon (DCB) in the treatment of subjects with symptomatic peripheral artery disease (PAD) due to de novo stenoses of the femoral and popliteal arteries. The trial will enroll up to 15 subjects.
Physical Activity Behavior Change for Older Adults After Dysvascular Amputation
AmputationDiabetes Mellitus2 moreThis pilot study will use mobile-health technology to deliver an intervention designed for lasting physical activity behavior change. The study will assess the feasibility of using the Physical Activity Behavior Change(PABC) intervention for Veterans with lower limb amputation. This intervention will be delivered using wrist-worn wearable activity sensors and a home-based tablet computer to allow real-time physical activity feedback and video interface between the participants and the therapist.
Study of LLG783 in Patients With Peripheral Artery Disease (PAD) and Intermittent Claudication
Peripheral Artery Disease (PAD); Intermittent ClaudicationThis study is designed to determine whether LLG783 displays the clinical safety and efficacy profile, after multiple i.v. doses, to support further development in patients with PAD and intermittent claudication.
Drug-Eluting Balloon Catheters and the Treatment of Peripheral Arterial Occlusive Disease
Peripheral Arterial DiseaseStenotic Femoro-popliteal Arteries2 moreThe purpose of this study is to determine plasma levels of paclitaxel and catheter tolerability subsequent to treating patients with peripheral arterial occlusive disease (PAOD) with paclitaxel-coated balloon catheters.
Effect of VascuActive Device on Foot Perfusion, Hemodynamics and Exercise Capacity in Patients With...
Peripheral Vascular DiseasesThe purpose of this study is to assess the safety and the immediate effect of the VascuActive device on patients with peripheral vascular disease and limb ischemia.
The Complete® Self-Expanding Stent and Stent Delivery System Registry
Peripheral Vascular DiseaseThe purpose of this study is to show if a new delivery system with a modified stent is safe in treating occluded iliac arteries in patients with peripheral vascular disease. The modified Complete SE delivery system is hypothesized to assist physicians with more accurate stent placement reducing the likelihood of stent 'jumping' seen with the use of many self-expanding stent systems.
Study of SilverHawk®/TurboHawk® in Lower Extremity Vessels (DEFINITIVE™ LE)
Peripheral Arterial DiseaseClaudication1 moreThe purpose of the study is to evaluate the intermediate and long-term effectiveness of stand-alone atherectomy treatment of peripheral arterial disease in the legs.
A Multiple Ascending Dose Study of RO4905417 in Healthy Volunteers and Patients With Peripheral...
Peripheral Arterial Disease (PAD)This single center, multiple ascending dose study will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of RO4905417 at different doses in healthy volunteers and patients with peripheral arterial disease. Three groups of 10 healthy volunteers will receive RO4905417 (either 3mg/kg, 7mg/kg or 20mg/kg) or placebo iv every 28 days for a total of 3 infusions. In addition, two groups of 6 PAD patients will receive RO4905417 (either 3mg/kg, 7mg/kg) or placebo and 1 group of 20 PAD patients will receive 20mg/kg RO4905417 or placebo iv every 28 days for a total of three infusions. The study will have an adaptive design with ongoing assessment of safety and tolerability prior to initiation of the next dose. All subjects will receive 3 doses of RO4905417 or matching placebo at 28 day intervals. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.
Efficacy and Safety Study of NV1FGF in Patients With Severe Peripheral Artery Occlusive Disease....
Severe Peripheral Artery Occlusive DiseasePeripheral Arterial Occlusive Disease (PAOD) is a condition caused by ischemia in the legs due to atherosclerotic disease affecting the larger arteries of the legs. Chronic PAOD can be regarded as a marker of generalized atherosclerosis. PAOD threatens the survival of an extremity and often causes lifelong disablement from a painful leg. The clinical consequences of PAOD include pain on walking (claudication), pain at rest and loss of tissue integrity in the distal limbs.A variety of medical therapies have been investigated for patients with PAOD. There is currently no evidence to suggest that any medical therapy is effective for patients with rest pain and/or ischemic ulcers. Also, the use of intramuscular angiogenic VEGF-A gene transfer has recently demonstrated a improvement in clinical and hemodynamic status in patients with severe PAOD