Arterial Inflow and Muscle Ischemia During Calf Stimulation With the Veinoplus Device
Peripheral Artery DiseaseStimulation of arterial inflow to the lower limb is important to obtain functional improvement in peripheral artery diseased (PAD) patients with claudication. The clinical effect of muscle stimulation to increase arterial inflow and the direct evaluation of the regional blood flow impairment (RBFI) in the area of stimulation, have not been evaluated in PAD patients. Fifteen adult patients with stable arterial claudication will participate. Recruitment will be performed among patients referred for exercise oxymetry (treadmill: 3.2km.h-1, 10% slope) After two minutes of rest, the gastrocnemius will be stimulated for 20 minutes at an increasing frequency rate with 5 min steps (1 Hz, 1.25 Hz, 1.5 Hz and 1.75 Hz) on the most symptomatic side. The investigators record the tcpo2 value, arterial blood inflow with ultrasound of the femoral artery, and near infra-red spectrometry (NIRS) on both sides. Patients will be instructed to report eventual contraction-induced pain in the stimulated calf.
IN.PACT Global Clinical Study
Peripheral Arterial DiseaseThe purpose of this study is to collect safety and efficacy data on the IN.PACT Admiral™ Drug Eluting Balloon (DEB) in treatment of atherosclerotic disease in the superficial femoral and/or popliteal arteries in a "real world" patient population.
Pilot Study of PRT-201 Following Angioplasty in Patients With Peripheral Artery Disease (PAD)
Peripheral Artery DiseaseThe purpose of this study is to determine if it is safe and feasible to apply PRT-201 to the adventitia of arteries following successful angioplasty (PTA).
NanoCross BTK, a Prospective, Non-randomized, Multicenter, Controlled Trial Evaluating the Performance...
Peripheral Arterial DiseaseThe objective of this clinical evaluation is to evaluate the immediate and long-term (up to 12 months) outcome of NanoCrossTM balloon catheter (Covidien) in a prospective, non-randomised, controlled investigation for the treatment of patients with critical limb ischemia (Rutherford 4-5) due to the presence of lesions of minimally 10cm in length at the level of the below-the-knee arteries.
Study of Human Placenta-derived Cells (PDA002) to Evaluate the Safety and Effectiveness in Subjects...
Peripheral Arterial DiseaseDiabetic FootThis clinical study is being conducted to assess the safety and determine the maximum tolerated dose (MTD) of PDA-002 [human placenta-derived cells] administered into the lower leg muscles of subjects with peripheral arterial disease and diabetic foot ulcers. It will look to see if PDA-002 helps reduce some of the symptoms of PAD and/or improves ulcer healing. This study will also help to find the best dose of PDA-002 to use in future studies.
Evaluation of Compression Therapy in Patients With Mild to Moderate PAD or Diabetes Mellitus
Peripheral Arterial DiseaseDiabetes Mellitus1 moreAim of this prospective clinical study is the Evaluation of the Effect of Compression Therapy on the Microcirculation in Patients With Leg Edema and Mild to Moderate PAD or Diabetes Mellitus.
ILLUMENATE Pivotal Post-Approval Study (PAS)
Peripheral Artery DiseaseThe ILLUMENATE Pivotal PAS is a continued follow-up study which will include 300 subjects from forty-three (43) sites across the United States and Austria previously enrolled in the ILLUMENATE Pivotal pre-market study to evaluate the Stellarex DCB compared to the PTA control device for the treatment of de-novo or post-PTA occluded/stenotic or reoccluded/restenotic (except for in-stent) SFA and/or popliteal arteries.
PRospective Study for the TrEatment of Atherosclerotic Lesions in the Superficial Femoral and/or...
Peripheral Arterial DiseaseTo assess preliminary safety and efficacy of the Serranator™ Alto PTA Serration Balloon Catheter in subjects with atherosclerotic peripheral artery disease of the superficial femoral and popliteal arteries.
Natural Vascular Scaffold (NVS) Therapy
Peripheral Arterial DiseasePeripheral Vascular Diseases2 moreThe NVS Therapy is being studied to evaluate the safety and efficacy of retention of acute luminal gain, leading to acute hemodynamic improvement in superficial femoral and popliteal arteries with reference vessel diameters between 3.5 and 7.0 mm and lesion lengths between 36 and 96mm. The system is intended for use in patients with de novo lesions in the superficial femoral and proximal popliteal arteries.
Study to Evaluate the Lower Extremity Intervention With Integrated Embolic Protection Using the...
Peripheral Arterial DiseaseIntermittent Claudication1 moreThe ENTRAP Study is a prospective, multi-center, non-randomized, single-arm, study with follow-up to 30 days to determine the acute safety, acute device performance and clinical performance of the Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection. The Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection is indicated for peripheral vascular percutaneous transluminal angioplasty (PTA) and capture and removal of embolic material during angioplasty for the femoral, iliac, popliteal and profunda arteries.