Safety and Efficacy of Propionyl-L-Carnitine in the Treatment of Peripheral Arterial Disease (Intermittent...
Peripheral Vascular DiseasesIntermittent ClaudicationPatients with peripheral artery disease have decreased blood flow to exercising muscle causing pain. This decreased blood flow to the muscle affects the level of acylcarnitines which in turn decreases the level of carnitine. Carnitine allows muscles to function properly. This study will test the safety and efficacy of Propionyl-L-Carnitine taken in combination with a monitored exercise training program.
A Safety and Efficacy Study of the Dynalink®-E Everolimus Eluting Peripheral Stent System
AtherosclerosisPeripheral Vascular DiseaseThe purpose of this first-in-man study is to evaluate the safety and performance of the Dynalink®-E everolimus eluting peripheral stent system for the treatment of patients with atherosclerotic de novo or restenotic native superficial femoral and proximal popliteal lesions. Abbott Vascular is ceasing data analysis of the STRIDES Clinical Trial after 2 years. The decision to discontinue the study is not related to any safety concern. The rationale for this proposal is based on the following considerations: The performance of DYNALINK-E from STRIDES shows no device- or procedure-related deaths and no stent fractures, and the rate of additional revascularizations has been stable since approximately 14 months after the procedure. Evaluations of the bare metal nitinol DYNALINK and ABSOLUTE stents in the clinical literature show low rates of death, reintervention and stent fracture, which are consistent with STRIDES and demonstrate the safety of the nitinol stent platform of the DYNALINK-E. Long-term animal studies show no concerns with the drug or polymer coating of DYNALINK-E - everolimus tissue concentration drops below the quantifiable limit by approximately 17 months after implant, and vascular response to the coating is normal with widely patent lumens and struts incorporated into vessel tissue. The safety and performance of the DYNALINK-E has been substantiated by its clinical and pre-clinical data, and by the clinical data of similar products. Given the demonstrated mechanical integrity of the stent along with the evidence of a healthy long-term vascular response, there is a reasonable expectation of continued low event rates.
XIENCE V: SPIRIT WOMEN
Coronary Artery StenosisCoronary Arteriosclerosis6 moreThe purpose of this Clinical Evaluation is the continued assessment of the XIENCE Everolimus Eluting Coronary Stent System (XIENCE V® and XIENCE PRIME™ EECSS) with the primary focus on clinical outcomes in the treatment of female patients with de novo coronary artery lesions, and the characterization of the female population undergoing stent implantation with a XIENCE stent.
Counseling Older Adults to Control Hypertension
HypertensionVascular Diseases1 moreThis study will evaluate the effect of a senior center-based comprehensive therapeutic lifestyle intervention delivered through group-based counseling and motivational interviewing (MINT-TLC) among 250 hypertensive African American or Latino seniors age 60 and older in a randomized control trial.
Evaluating Two Exercise Training Programs to Reduce Leg Pain in People With Peripheral Arterial...
Intermittent ClaudicationPeripheral Vascular DiseasesPeripheral arterial disease (PAD) is a disorder that affects more than 8 million people in the United States. As a result of decreased blood flow to the legs, people with PAD may experience leg pain and difficulty with walking. This study will examine the effectiveness of two exercise programs-a treadmill walking program and an aerobic arm exercise program-at increasing walking distance and decreasing leg pain in people with PAD.
Intra-arterial Stem Cell Therapy for Patients With Chronic Limb Ischemia (CLI)
Peripheral Vascular DiseasesArterial Occlusive Diseases3 moreThe purposes of this study are to determine whether intra-arterial injection of autologous stem cells is effective in the treatment of chronic limb ischemia (CLI), to characterize stem cell dysfunction in patients with CLI, and to relate the stem cell function with clinical outcome.
Study of Hepatocyte Growth Factor (HGF) Via Plasmid Vector to Improve Perfusion in Critical Limb...
Arterial Occlusive DiseasePeripheral Vascular Disease2 moreThe objective of this study is to test the hypothesis that AMG0001 treatment is safe and induces angiogenesis as detected by improved wound healing, reduction in amputation, improved pain at rest and hemodynamic measurement and to assess the effectiveness of the administrative method.
Mirror Trial - Follow-Up Management of Peripheral Arterial Intervention With Clopidogrel
Peripheral Vascular DiseasesThe Mirror Study is a randomized, double-blinded mono-centre trial the access the periinterventinal and postinterventional administration of clopidogrel in patients with peripheral vascular disease.
Extract of Ginkgo Biloba (EGB 761) and Vascular Function
Intermittent ClaudicationPeripheral Vascular DiseaseThis study will determine if a highly standardized herbal extract of the leaves of the Ginkgo Biloba tree will benefit patients who have pain on walking due to narrowing of the arteries of the legs.
Study of HGF Via Plasmid Vector to Improve Perfusion in Critical Limb Ischemia
Arterial Occlusive DiseasePeripheral Vascular Disease1 moreThe primary purpose of this study was to assess the overall safety of different dose regimens of AMG0001 (HGF transferred via plasmid vector) as well as evaluate the improvement of blood perfusion in subjects with critical limb ischemia (CLI). This study also evaluated the improvement in wound healing without adverse effects on the quality of life, as well as the potential reduction of amputation, mortality and rest pain in the CLI population.