Real-World Registry Assessing the Clinical Use of the Lutonix 035 Drug Coated Balloon Catheter
Peripheral Arterial DiseasePeripheral Vascular Diseases1 moreThe objective of this patient registry is to assess the clinical use of the Lutonix 035 DCB PTA Catheter in a heterogeneous patient population in a real world and on-label clinical application.
Ultrasound to Enhance Paclitaxel Uptake in Critical Limb Ischemia: the PACUS Trial
Peripheral Arterial DiseaseAngioplastyThe PACUS Trial was a single center, single blinded, randomized trial designed to evaluate the safety and efficacy of intravascular percutaneous catheter-delivered ultrasound energy to improve local Paclitaxel delivery effects in critical limb ischemia patients due to femoral-popliteal artery disease.
York Study of Unloading Shoes for Vascular Intermittent Claudication
Intermittent ClaudicationPeripheral Arterial DiseaseSome people experience a cramp-like leg pain during walking that is relieved only by rest. This is called intermittent claudication (IC) and it is a common symptom of peripheral arterial disease. Patients with IC struggle to walk, which in turn lowers their quality of life. The intensity of IC pain experienced during walking depends on several factors, including the type of footwear worn. For example, non-supportive shoes may make the calf muscles work harder during walking, leading to earlier and more-severe symptoms of IC. A member of the research team has developed a shoe that reduces the work done by the lower-leg muscles during walking. Preliminary data indicate that, when wearing these "unloading shoes", people with IC were able to walk further without pain as compared with when wearing a normal pair of shoes. The current project aims to provide further information on the usefulness and acceptability of these shoes. Forty people with IC will complete a set of three walking tests on two separate occasions; once whilst wearing the unloading shoes, and once whilst wearing some normal shoes. The participants will then be given a pair of unloading or normal shoes to wear for two weeks, after which we will collect information on how acceptable the shoes were to wear via a survey of all participants and one-to-one interviews with a subset of participants.
A Single-dose Escalation Safety and PK Study for PLC in Healthy Chinese
Peripheral Arterial DiseaseThe main objective is to evaluate the effect of single dose Propionyl-L-Carnitine Hydrochloride on clinical pharmacokinetic characteristics and its effect of clinical pharmacokinetic characteristics and safety on healthy Chinese subjects to provide a basis for market authorization registration.
Robotic-Assisted Peripheral Intervention for Peripheral Arterial Disease II
Peripheral Arterial DiseaseThe purpose of this study is to evaluate the safety and performance of the CorPath 200 System in the remote delivery and manipulation of guidewires and rapid exchange catheters for use in percutaneous vascular interventions.
ILLUMENATE EU Randomized Clinical Trial
Peripheral Arterial DiseaseClaudicationThis is a prospective, randomized, multi-center, single-blind study to demonstrate the safety and effectiveness of the CVI Paclitaxel-coated percutaneous transluminal angioplasty (PTA) balloon versus bare PTA balloon for the treatment of patients with de novo occluded/stenotic or reoccluded/restenotic lesions of the superficial femoral (SFA) and popliteal arteries.
BioMimics 3D Stent Clinical Investigation: The Mimics Study
Peripheral Arterial DiseasePrimary 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.
EverFlex™ Self-expanding Peripheral Stent With Entrust™ Delivery System Clinical Study
Peripheral Arterial DiseasesThe purpose of this study is to collect acute confirmatory data to evaluate technical success and acute safety of the EverFlex™ self-expanding peripheral stent with Entrust™ delivery system.
A Phase IIB Pilot Study of a Modified Dosage Regimen of AMG0001 in Subjects With Critical Limb Ischemia...
Critical Limb IschemiaVascular Diseases1 moreThe purpose of the study is to confirm the feasibility of study procedures and the tolerability of a new dose regimen of AMG0001 in subjects with Critical Limb Ischemia (CLI)
Cook Micronized Small Intestinal Submucosa (SIS) for Critical Limb Ischemia
IschemiaPeripheral Arterial Disease1 moreThis study is intended to collect safety and effectiveness data on the Cook Micronized Small Intestinal Submucosa (SIS)