Post-operative Treatment of Diabetic Peripheral Arterial Disease Guided by Platelet Reactivity Unit...
Peripheral Artery DiseaseTo compare the effect of PRU(platelet (P2Y12) reaction units)-guided treatment on the change in time of initial leg pain and time of termination of exercise test by pain, evaluated on the graded stationary bicycle test, the lower limb perfusion by using MRI blood oxygenation-level dependent (BOLD) and dynamic contrast enhancement sequences and measures the extracellular volume fraction (ECV) as an indicator of fibrosis severity in calf muscles, from one to 52 weeks post-revascularization in patients with peripheral artery disease who have undergone endovascular revascularization -/+ bypass surgery for moderate to severe claudication or ischemic rest pain.
Study of Drug Eluting Peripheral Vascular Stent System in Superficial Femoral Artery Stenosis and...
Peripheral Arterial DiseaseSuperficial Femoral Artery Stenosis1 moreEvaluation of drug eluting peripheral vascular stent system for the treatment of superficial femoral artery stenosis and / or occlusion, there is better in effectiveness and clinical performance compared with similar products already on the market.
Multi-spectral Imaging to Assess Wounds in Peripheral Vascular Disease Patients
Peripheral Vascular Disease PatientPeripheral vascular disease (PVD) is a common disease of impaired blood flow resulting in the compromised tissue perfusion of lower limbs. PAD patients can experience pain, diminished exercise capacity, and tissue loss, with some ultimately requiring amputation. The economic burden of PVD is significant. In the United States alone, PVD accounts for over $20 billion in annual healthcare related costs. The demand for the development of an effective method to characterize the viability of PVD wounds has resulted in the emergence of several innovative techniques. Commonly used diagnostic methods are ankle-brachial index (ABI), pulse volume recordings, duplex ultrasonography, venous plethysmography, Transcutaneous oxygen tension (TcPO2), toe pressures, angiography by X-ray, computed tomography, and magnetic resonance imaging. Currently, angiography remains the diagnostic gold standard. However, many of these techniques lack the ability to triage and adequately determine the viability of the wound. In addition, there remains a need for effective triage technologies to help clinicians decide whether surgical management is needed. Early determination of surgical versus conservative management may help to improve patient functional outcomes, reduce mortality rates, and prevent limb amputation. Near-infrared point spectroscopy (NIRS) is a non-invasively technology with recent applications in PVD wound assessment. To date, studies have demonstrated the validity of NIRS technology in patients with peripheral arterial disease. NIRS measures flow, concentration, and oxygenation of hemoglobin in arterioles, capillaries, and venules several centimeters deep in tissue. The MSID is an evolution of existing NIRS imaging devices and has become a portable and functional commercial device produced by KENT imaging (Calgary, Canada). Using this new and clinically applicable NIRS technology designed for assessing wound perfusion and oxygenation, this study seeks to adequately identify viable from non-viable wounds and to rapidly determine indication for vascular interventions. This technology is well-suited for use in a wound patient population as the measurements times are short and can quickly be used at the patient bed side. As such, this project intends to apply NIR technology to quickly assess PVD in the investigators' patient population.
REFLOW Study, Investigating the Efficacy of the LEGFLOW DCB in TASC C&D Fempop Lesions
Peripheral Arterial DiseaseA physician initiated trial investigating the LEGFLOW Paclitaxel-Eluting Peripheral Balloon dilatation catheter for the treatment of femoropopliteal lesions longer than 15cm. Objective: to evaluate the short-term outcome of the treatment by means of the LEGFLOW Paclitaxel-Eluting Peripheral BAlloon Dilattaion for the treatment of long femoropopliteal lesions (TASC C&D).
Angioplasty + SBCV vs. Angioplasty Alone for Femoropopliteal Artery Stenosis
Peripheral Arterial DiseaseThe purpose of this study is to compare balloon angioplasty plus SBCV against balloon angioplasty alone for treatment of stenosis within the femoropopliteal artery.
A Study of The Femoral Popliteal Artery Treated With LEGFLOW OTW
Peripheral Arterial DiseaseTo evaluate the safety and efficacy of the Paclitaxel Releasing Peripheral Balloon Dilatation Catheter (LEGFLOW) compared with the standard balloon (Admiral Xtreme) for the treatment of stenosis or occlusions in femoral popliteal artery.
Use of Allogenic Platelet Lysate in Peripheral Arterial Disease (PAD)
Peripheral Arterial DiseaseAllogenic platelet lysate will be injected in the gastrocnemius of patients with peripheral arterial disease (PAD)
Effectiveness and Safety of Adipose-Derived Regenerative Cells for the Treatment of Critical Lower...
Critical Limb IschemiaArteriosclerosis Obliterans3 moreAdipose-derived regenerative cells (ADRC) will be extracted from lipoaspirate by enzymatic digestion. 10 mL of autologous ADRC suspension injected intramuscularly, close to the site of muscle injury. All patients will receive cell therapy. This is a single arm study with no control.
Umbilical Cord Mesenchymal Stem Cells Infusion for Diabetes Related Vascular Complications
Peripheral Vascular DiseaseIschemia1 moreStem cell therapy has been a new and effective therapy in recent years for diabetic foot.This study intends to establish an optimal clinical research program, and attempts to break the technical bottleneck in the stem cell therapy for treating diabetes related vascular complications.
Embolization Procedures in the Peripheral Vasculature Using the Magellan™ Robotic System
Peripheral Vascular DiseaseThe purpose of this prospective study is to gather procedural use and safety data on the initial use of the Magellan Robotic System with the Magellan Robotic Catheter 6 Fr, Vascular Accessories 6 Fr and Microcatheter Driver This study will focus on, but not be limited to, endovascular embolization procedures in the peripheral vascular, for example, embolization of the splenic and hepatic arteries, uterine arterial embolization (UAE), prostatic arterial embolization (PAE), and trans-arterial chemoembolization (TACE). The data will be analyzed for medical education, societal presentation and/or publication by the investigator.