Electrical Stimulation as an Adjunctive Therapy to Increase Vascular Perfusion in People With PAD...
PAD - Peripheral Arterial DiseasePVD- Peripheral Vascular DiseaseThe purpose of this study is to apply Avazzia micro-current stimulation to patients with chronic, non-healing wounds to determine if this therapy is effective in perfusion and bacterial measurements.
The Study of the Fenestrated Anaconda Device in the Treatment of Abdominal Aortic Aneurysms
Vascular DiseasesAneurysmThe French Ministry registered the Fenestrated Anaconda ™ on the List of Reimbursable Products and Services (LPPR) by the French Health Insurance on February 2018 for a duration of 5 years, while taking up the conditions for carrying out the act recommended by the CNEDiMTS (Committee in charge of medical device review), namely the carrying out of a post-registration study for the renewal of the authorization. This renewal of registration is conditioned by the set-up of a long-term follow-up study of all patients treated with the Fenestrated Anaconda ™ in France. To do this, this study will be carried out in partnership with the Federation of Medical Specialties (FSM) and the National Professional Council (CNP) of Vascular Surgery in order to have the data necessary for the renewal of the registration of the Fenestrated Anaconda ™ from the registry called Datavasc developed by the CNP and available online on the FSM's electronic platform.
Intermittent Negative Pressure; Impact on Peripheral Artery Disease and Intermittent Claudication...
Peripheral Vascular DiseaseIntermittent Claudication4 moreThe objective is to ensure the pro-active collection of information on quality, safety and performance of FlowOx™ after it is placed on the market. The study will be carried out in a patient population with peripheral artery disease (claudicatio intermittens) to confirm its usefulness and in particular gather information for further improvements of the device related to this patient population. The data collected from the use of the CE-marked FlowOX™ device are change of walking distance, quality of life, and the patient's compliance.
iSONEP to Treat Persistent Pigment Epithelial Detachment (PED) in Subjects With Exudative Age-Related...
Pigment Epithelial DetachmentLT1009-Oph-002 is a Phase 1b study designed to evaluate the safety and potential efficacy of iSONEP following one, two or three injections of iSONEP, as needed, for the treatment of Pigment Epithelial Detachment (PED) secondary to PED Secondary to Exudative Age-Related Macular Degeneration (AMD) or Polypoidal Choroidal Vasculopathy (PCV).
Study of Post-meal Blood Sugar Peaks in Association With Vascular Disease in Childhood Obesity
Pediatric ObesityInsulin Resistance2 moreThe main purpose of this study is to determine whether treatment with acarbose attenuates post-prandial glycemic excursions in non-diabetic/pre-diabetic obese children as determined by continuous glucose monitoring systems (CGMS). To this effect the current pilot study involves a 6 week intervention with acarbose given to all subjects with either impaired glucose tolerance or an area under the curve of >130 mg/dl during the screening oral glucose tolerance test. Three consecutive days of CGMS are then compared to before and during the intervention. The secondary objective addressed in this protocol is the collection of baseline measures of endothelial function in obese and lean children. Even though the duration of acarbose treatment may be too short to demonstrate a vascular effect, the pre and post intervention data would serve as preliminary data for anticipated future studies that assess the vascular effect of reduced post-prandial blood glucose levels.
Balloon Angioplasty vs. Cutting Balloon Angioplasty of Femoropopliteal Arteries- a Randomized Controlled...
Peripheral Vascular DiseaseIntermittent Claudication2 moreThe purpose of this study to compare balloon angioplasty (PTA) vs. cutting balloon angioplasty (CB-PTA) in terms of patency and postintervention inflammation in peripheral artery disease.
Study to Evaluate Safety & Effectiveness of Vascular Sealant System
Peripheral Vascular DiseaseTo evaluate a new vascular sealant compared to control for the control of suture line bleeding after vascular reconstructive surgery.
Safety and Efficacy of the URECA CTO Device
Peripheral Vascular DiseaseClinical study to investigate the safety and the efficacy of the URECA CTO Device during recanalization and mechanical re-entry into the true lumen after passing the occlusions/calcifications (chronic total occlusions) in the peripheral vasculature.
Pilot Study of Topographic Imaging of the Calf Muscle in Patients With PAD Using 3D Reconstruction...
Peripheral Vascular DiseasesPeripheral Arterial DiseaseThe aim of this explorative pilot study is to present muscle perfusion of the lower extremity in patients with PAD using the Multispectral Optoacoustic Tomography (MSOT) method to build a 3D reconstruction of the calf muscle. This study aims to show the feasibility of 3D reconstruction of this non-invasive method. Advantages in diagnostics for patients with PAD and three-dimensional tomography representation of the perfusion situation based on muscle oxygenation will be evaluated.
Efficacy and Safety of LFG316 in Transplant Associated Microangiopathy (TAM) Patients
Transplant Associated Microangiopathy TAMThis was a randomized, SoC-controlled, open-label, multi-center study in patients with TAM after hematopoietic precursor cell transplantation (HPCT) . Study consisted of up to 28 days of screening period, 16 weeks treatment period that can be extended to 45 weeks.Approximately 40 patients was to be randomized to receive SoC or LFG316 plus SoC. Patients was included in the study if they have diagnosis of TAM and poor prognostic markers. This trial was terminated: LFG316, a monoclonal antibody inhibitor of complement factor 5 (C5), had been studied in seven patients with transplantation-associated microangiopathy (TAM). Due to low confidence of clinical benefit, this study was closed