Rapamycin Coated Balloon Dilation Catheter for Arteriovenous Fistula
Peripheral Arterial DiseaseVerify the effectiveness and safety of rapamycin coated balloon dilation catheter for the treatment of dialysis pathway stenosis or blockage lesions.
The Role of microRNA-210 in Regulating Oxidative Stress in Patients With PAD
Peripheral Arterial DiseaseVascular Diseases3 moreMicroRNA-210 (miR-210) can be a potential therapeutic target of patients with peripheral artery disease (PAD). Recent evidence suggests the role of miR-210 and oxidative stress in the pathophysiology of PAD and its association with mitochondrial function, oxidative metabolism, walking distances and quality of life. The protocol evaluates the mechanisms which miR-210 regulates oxidative stress and provides evidence of potential therapeutic strategies.
European All-comers' Multicentric Prospective REGISTRY on LUMINOR© Drug Eluting Balloon in the Superficial...
AngioplastyPeripheral Arterial Disease3 moreThe objective of this all-comers registry is to explore the safety, efficacy, and cost-efficiency of the LUMINOR© DEB in de-novo and restenotic-FP lesions. For de-novo and restenotic lesions, especially for calcified and/or long lesions/occlusions, the use of debulking devices to improve recalibration and drug penetration will be evaluated in a specific sub-group.
ULTRASCORE™ Focused Force PTA Balloon Angioplasty for CLI Patients With Below the Knee Vessel Disease...
Peripheral Arterial Disease (PAD)The purpose of this single-arm, exploratory study is to evaluate safety and performance of treatment of critical limb ischemia (CLI) with the ULTRASCORE™ Focused Force balloon. Patients with CLI in below the knee vessels will receive a percutaneous transluminal angioplasty with the device and will be followed up for 12 months.
The Effects of Allicor on Patients After Revascularization Treatment During a Year
AtherosclerosisPeripheral Arterial DiseaseA significant challenge in medical care is atherosclerotic occlusion of peripheral arteries, such as lower extremities and brachiocephalic arteries, which can eventually lead to loss of limbs or fatal ischemic strokes. Revascularizing surgical interventions can restore the lumen of the arteries and provide an effective way to treat such patients. However, up to a third of patients need re-intervention or experience cardiovascular complications within a year after surgery. The purpose of this study is to evaluate the effect of adding the natural dietary supplement Allicor to conventional treatment on the incidence of cardiovascular complications and treatment effectiveness 12 months after revascularization. Another valuable area of investigation is the search for predictors of long-term cardiovascular complications after revascularization, which could be markers of inflammation and heteroplasmy levels in the patient's mitochondrial genome.
Endovascular Treatment of Primary Common FEmoral Artery atheroSclerotic Disease wiTh IntraVAscular...
Peripheral Arterial DiseaseCommon Femoral Artery Stenosis2 moreProspective, nonrandomized, multicenter, national, multidisciplinary, real-world data collection with the aim to evaluate the short-term safety and efficacy of intravascular lithotripsy in the treatment of steno-obstructive disease of the common femoral artery
Measuring the ACT During Non-cardiac Arterial Procedures.
Arterial DiseaseSurgery2 moreAim of the MANCO study is to establish for once and for all that monitoring the effect of heparin during NCVI (Non-Cardiac Vascular Interventions) is essential to ensure the individual patient of safe and tailor-made anticoagulation. Not measuring the effect of the administered heparin exposes the patient to unnecessary risks of thrombo-embolic and bleeding complications. First aim of the MANCO study is to prove that the standardized bolus of 5000 IU of heparin, used by 90% of vascular specialists in Europe, results in inadequate anticoagulation in more than 80% of patients. These measurements will be performed using the Hemostasis Management System by Medtronic.
A Clinical and Histological Analysis of Mesenchymal Stem Cells in Amputation
IschemiaPeripheral Arterial Disease9 morePatients undergoing semi-elective lower extremity major amputation from complications associated with atherosclerotic limb ischemia will received intra-muscular injections of allogeneic Mesenchymal Stromal Cells in the leg above and below the point of amputation to prevent ischemic wound complications after surgery and decrease the incidence of revision and further amputation. Cohort Groups 1-4 will serve as controls.
Investigating the Safety and Clinical Performance of Seven iVascular Devices for Endovascular Intervention...
Peripheral Arterial Disease Below The KneeThe rationale of this study is to confirm and support the clinical safety and performance of the Oceanus 14pro, Oceanus 18 and Oceanus 35 Balloon Catheters, the Luminor 14m and Luminor 18 Drug Coated Balloons, the Angiolite BTK Sirolimus Eluting Peripheral Stent System and the Sergeant Peripheral Support Catheter in a real-word population of 143 patients who underwent an endovascular intervention the popliteal and/or infrapopliteal arteries within standard-of-care (SOC) where at least 1 of the investigational products from iVascular were used.
Clinical Evaluation of the BlueDop Vascular Expert for Assessing Peripheral Arterial Disease
Peripheral Arterial DiseaseThis is a BlueDop Vascular Expert System (BVE) Post-Market Clinical Follow-Up (PMCF) study. The primary objective of the study is to assess the clinical applicability and diagnostic accuracy of the BVE device in subjects who require an arterial duplex test due to suspected peripheral arterial disease (PAD).