Clinical Research Directory

A Study Evaluating the Endovascular Treatment of Subjects With Stenotic or Restenotic Lesions of the Common Femoral Artery With the Supera Vascular Mimetic Implant Compared to Surgical Common Femoral Artery Endarterectomy

The SUPERSURG RCT trial investigates the efficacy and safety of the endovascular treatment of stenosis or restenosis in the common femoral artery (CFA) of patients presenting with Rutherford classification 2,3 or 4 with a Supera Vascular Mimetic Implant of Abbott, compared to classic surgical common femoral artery endarterectomy. The Supera Vascular Mimetic Implant has an interwoven design and has a high crush resistance and is, when correctly implanted, an ideal stent to treat eccentric calcified plaques in the CFA. An expected total of 143 patients will be treated with the Vascular Mimetic Implant of Abbott and compared to a control group of another 143 patients that will be treated with classic surgical endarterectomy of the common femoral artery. Assignment to the treatment groups will be at random. Patients will be invited for a follow-up visit at 1, 6, 12, 24 and 36 months post-procedure. The primary efficacy endpoint is defined as follows: freedom from clinically-driven target lesion revascularization and binary restenosis at 12 months. The primary safety endpoint is defined as follows: a composite of overall death, cardiac, pulmonary, renal complications, sepsis, target lesion revascularisation and wound related complications through 30 days post-index procedure. The secondary endpoints are defined as technical success, primary patency in the deep femoral artery, primary patency in the target lesion, target lesion revascularisation, target vessel revascularisation, binary restenosis, duration of initial hospital stay, sustained clinical improvement, change of walking impairment questionnaire score from baseline, change in target limb Rutherford classification, change in target limb ABI/TBI from baseline, all cause death, thrombosis at the target lesion through 6, 12, 24 and 36 months post-procedure.

EVERO Drug-coated Balloon (DCB) Randomized Trial

The primary objective of the study is to evaluate the long-term safety and effectiveness of the Advance Evero™ 18 Everolimus-coated Percutaneous Transluminal Angioplasty Balloon Catheter (hereafter referred to as the Evero drug-coated balloon \[DCB\]) in the treatment of the femoropopliteal artery lesions in patients with peripheral arterial disease (PAD). Specifically, the Randomized-Controlled Trial (RCT) is designed to demonstrate non-inferior safety and non-inferior effectiveness of the Evero DCB when compared to commercially available paclitaxel DCBs (pDCBs).

Efficacy and Safety of Orforglipron in Participants With Peripheral Artery Disease

The purpose of this study is to evaluate the effect and safety of orforglipron once daily in participants with Fontaine II peripheral arterial disease (PAD). Participation in the study will last about 58 weeks.

A Clinical Evaluation of the MicroSTent® PeripherAl Vascular SteNt in Subjects With Arterial Disease Below the Knee (STAND)

Randomized multicenter clinical trial consisting of two arms; one arm treated with PTA plus the MicroStent® System and one arm treated with PTA alone. Purpose to evaluate the safety and effectiveness of using the MicroStent® Peripheral Vascular Stent System, hereafter referred to as the MicroStent® System, for the treatment of infrapopliteal lesions in subjects with peripheral arterial disease.

DCB Outcomes After Non-Compliant Balloon Vessel Preparation With or Without Scoring in Patients With Femoropopliteal Arterial Disease

The aim of this clinical trial is to determine whether vessel preparation with a non-compliant scoring balloon before drug-coated balloon (DCB) angioplasty provides superior procedural and clinical outcomes compared with vessel preparation using a non-compliant plain balloon in patients with chronic limb-threatening ischaemia (CLTI) undergoing femoropopliteal endovascular intervention. The main questions the study aims to answer are: * Does non-compliant scoring balloon vessel preparation reduce the need for bailout stenting during the index procedure? * Does it improve primary patency after DCB angioplasty? * Does it improve clinically relevant outcomes such as wound healing, freedom from clinically driven target lesion revascularisation, limb salvage and health-related quality of life? * Does it provide procedural and economic advantages compared with non-compliant plain balloon vessel preparation? Participants will be randomly assigned to undergo vessel preparation using either a non-compliant plain balloon or the DKutting™ non-compliant scoring balloon, followed by angioplasty with the Legflow XP™ drug-coated balloon. Patients will undergo clinical, duplex ultrasound and quality-of-life follow-up for 24 months.

Hemodynamic Characteristics of Peripheral Arterial Disease Using Computational Fluid Dynamics

Peripheral arterial disease can reduce blood flow to the legs. This study will examine how blood flow patterns in the leg arteries differ between people with peripheral arterial disease and people without the disease. Researchers will use existing computed tomography angiography (CTA) images and medical records from participants who previously received CTA as part of routine clinical care. Three-dimensional models of the leg arteries will be created from these images. Computer simulations will then be used to study how changes in blood flow entering the arteries and resistance in smaller downstream blood vessels affect blood flow patterns. The researchers will compare these responses between participants with and without peripheral arterial disease. This study uses only existing medical records and images. No new participants will be recruited, and no additional examinations or treatments will be performed for research purposes. The goal is to better understand blood flow characteristics associated with peripheral arterial disease.

Developing Trustworthy Artificial Intelligence (AI)-Driven Tools to Predict Vascular Disease Risk and Progression

The VASCULAID-RETRO study, within the broader VASCULAID project, aims to create artificial intelligence (AI) algorithms that can predict cardiovascular events and the progression of abdominal aortic aneurysm (AAA) and peripheral arterial disease (PAD). The study plans to gather and analyze data from at least 5000 AAA and 6000 PAD patients, combining existing cohorts and retrospectively collected data. During this project, AI tools will be developed to perform automatic anatomical segmentation and analyses on multimodal imaging. AI prediction algorithms will be developed based on multisource data (imaging, medical history, -omics).

Low Dose ColchicinE in pAtients With Peripheral Artery DiseasE to Address Residual Vascular Risk

The Low dose ColchicinE in pAtients with peripheral Artery DiseasE to address residual vascular Risk (LEADER-PAD) trial will evaluate if anti-inflammatory therapy with colchicine will reduce vascular events in patients with symptomatic peripheral artery disease.

Combined Treatment for Non-Healing Wounds in Chronic Lower Extremity Arterial Disease: A Comparative Study

Endovascular interventions, such as balloon angioplasty and stenting, are commonly used for PAD due to their proven safety and effectiveness. However, traditional treatments for chronic non-healing wounds are often insufficient. Advances in cell biotechnology, particularly fibroblast therapy, show promise for enhancing wound healing, as fibroblasts play a crucial role in tissue repair and inflammation. This study aims to develop, assess, and evaluate the safety of a combined treatment approach that incorporates fibroblast therapy with existing methods for managing chronic non-healing wounds in PAD patients.

Neuromuscular Electrical Stimulation in Peripheral Arterial Disease

This randomized controlled trial investigated the effects of neuromuscular electrical stimulation (NMES), in addition to optimal medical therapy (OMT), on walking capacity, pain, fatigue, and quality of life in individuals with intermittent claudication due to peripheral arterial disease (PAD). A total of 48 participants were randomly allocated to either the NMES or control group. Participants in the NMES group received NMES for 40 minutes per session, three times per week, for six weeks, in addition to OMT, whereas the control group received OMT alone. Outcome measures included walking capacity, pain, fatigue, disease-specific and generic quality of life, and ankle-brachial index (ABI). Assessments were performed at baseline and after the 6-week intervention.

Symptomatic and Systemic Atherosclerotic Plaque Activity in Patients With Peripheral Arterial Disease Using Novel Imaging

The goal of this observational study is to characterise the relationships between inflammation, microcalcification and thrombus activity in atherosclerotic plaques in peripheral and systemic vascular territories in patients with symptomatic peripheral arterial disease.

Cost-utility Analysis of the Outpatient Versus Conventional Hospitalization in Treatment of Occlusive Arterial Disease

The purpose of this study is to assess the efficiency of outpatient surgery compared to conventional hospitalization in endovascular treatment of occlusive arterial disease. A cost-utility analysis will be conducted from a societal perspective. Patients referred for peripheral arterial disease (PAD) will be randomized in two arms and a 3 months follow-up will be performed.

Advanta VXT and Flixene PMCF Registry

The purpose of the registry is to evaluate the long-term safety and performance of Advanta VXT and Flixene vascular grafts for repair or replacement of peripheral arteries. This registry is also intended to provide further data on the clinical usefulness of the Advanta VXT and Flixene vascular grafts.

A Single Arm Trial to Evaluate the Safety and Efficacy of the Long (> 150mm) PasseoTM-18 LuxTM Drug-coated Balloon in the Treatment of Subjects With Infrainguinal Stenotic, Restenotic or Occlusive Lesions

This clinical trial will evaluate the study device, Passeo®-18 Lux® paclitaxel-releasing percutaneous transluminal angioplasty (PTA) balloon catheter for the treatment of new or recurring cholesterol-related blockages in the arteries of the lower leg. The device that is used in this trial has been assessed in several previous studies for safety and effectiveness. The device is already approved for use in Europe. It has a "CE mark," which means it meets the European Union's safety, health and performance standards. This trial is being done to gather additional information on how well the device works and how safe it is when used in everyday medical care with specific attention to the longer lengths of the balloon, as it comes in different sizes.

Multimodal Physiologic State Intelligence Study

The OMNIPHYS study will investigate whether multimodal ultrasound and other routinely collected clinical and physiologic data can be combined with artificial intelligence to characterize changes in a person's physiologic state over time. The study will examine cardiac, vascular, pulmonary, and systemic physiologic measurements and develop longitudinal models that describe baseline physiology, physiologic perturbation, compensation, deterioration, treatment response, and recovery. The study is observational and will not assign experimental treatments. The goal is to determine whether changes in multimodal physiologic patterns can be identified and characterized earlier and more reliably than conventional single-time-point assessment.

Impact of Virtual Reality on Patient Pain During Lower Limb Revascularization Via Endovascular Surgery Under Local Anesthesia With Sedation

The prevalence of peripheral arterial disease (PAD) increases with age In addition to medical treatment, endovascular procedures can be performed, depending on the stage of the disease, to prevent complications and/or sequelae (relapse, functional loss of the affected limb, amputation, death), but also to relieve pain. This is a minimally invasive procedure most often performed under local anesthesia (LA), sometimes with the administration of sedatives (morphine and analgesics) to relieve pain and reduce anxiety related to the procedure. Non-pharmacological methods such as virtual reality (VR) are increasingly being used as an alternative to general anesthesia and excessive opioid use. The hypothesis is that VR could reduce pain during lower limb revascularization by endovascular surgery.

The Golazo® Peripheral Atherectomy System for a Safe and Effective Atherectomy (GREAT Trial)

The objective of this study is to establish reasonable assurance of safety and effectiveness of the Golazo® Peripheral Atherectomy System when used as indicated in 159 subjects with symptomatic infrainguinal peripheral arterial disease (PAD) in up to 20 investigational sites in the U.S.

Spectroscopic Assessment of Tissue Oxygenation Changes During Vascular Surgery

This study is a single-center, observational study designed to collect tissue spectrometric data related to tissue oxygenation.

Leg Exercise Assistive Paddling (LEAP) Therapy for Peripheral Artery Disease

The purpose of this study is to test the effects of leg exercise assistive paddling (LEAP) therapy during prolonged sitting (PS) on vascular and functional performance in those with peripheral artery disease (PAD) and age-matched controls. LEAP therapy is a novel application of passive limb movement to enhance blood flow through the legs without muscular contractions. Specifically, LEAP therapy is the rotational passive movement of the lower leg about the knee from 90 to 180 degrees of rotation at a cadence of 1Hz. Previous literature has indicated that this movement pattern can produce robust increases in blood flow in the passively moved limb in healthy individuals, and passive limb movement may protect vascular function during PS. However, the impact of LEAP therapy to improve blood flow in the legs of those with PAD during PS is unknown. Participants will participate in a randomized cross-over design study with 2 visits (LEAP therapy and no LEAP therapy). For the first visit, participants will be randomly allocated to receive LEAP therapy during 2.5 hours of PS or not. For the second visit, participants will sit for 2.5 hours and will receive the condition that they did not previously receive. Before and after PS, the following measurements will be made: flow-mediated dilation of the popliteal and brachial arteries, arterial stiffness with tonometry techniques, microvascular vasodilatory capacity and skeletal muscle metabolic rate with near-infrared spectroscopy, autonomic nervous system function, and there will be blood drawn from the antecubital vein. After PS, participants will participate in a graded exercise test to assess functional walking capacity. Finally, during PS, near-infrared spectroscopy on the calf muscles and electrocardiogram will be collected continuously to monitor muscle oxygen availability and autonomic activity, respectively.

FGF-1 for Intramuscular Injection for the Treatment of Peripheral Arterial Disease

FGF-1 for the treatment of patients with peripheral arterial disease with intermittent claudication.

CRUSH PAD: Real-world Outcomes Following Use of Shockwave Intravascular Lithotripsy (IVL) Technology in Calcified Common Femoral Lesions

The primary goal of the study is to obtain effect size data on the use of Shockwave Intravascular Lithotripsy (IVL) technology in calcified common femoral lesions in patients with peripheral artery disease for a series of endpoints, including target lesion revascularization and health status, to enable future planning of comparative effectiveness research.

VITUS Post-Market Registry

To collect post marketing surveillance data on consecutive patients with peripheral arterial occlusive disease (PAOD) intended to be or treated by the VITUS peripheral drug-coated dilatation catheter when used according to the Instructions for Use and treating physician decision. Data will be collected in order to assess the long-term safety and performance of the VITUS peripheral drug-coated dilatation catheter in routine clinical practice.

A Study of the Temporary Spur Stent for the Treatment of Narrowing and Blockages in the Arteries Below the Knee

The purpose of this study is to evaluate the performance and safety of the Temporary Spur Stent System (TSS). The TSS is intended for use in conjunction with a commercially available drug coated balloon in the infrapopliteal arteries for the treatment of de novo or restenotic lesions. This study is a prospective, non-randomized, multicenter, single arm trial, with sites in New Zealand, Germany, and Switzerland. At least two and no more than 10 sites are expected to participate, with 100 subjects enrolled (no more than 40 at a single site). The study follow up will take place over a period of 365 days. A vessel recoil substudy will be included for a select group of subjects.

Case-Specific Health Care Professional Clinical Survey of Liberant™ Thrombectomy System

The purpose of Case-Specific Health Care Professional (HCP) Clinical Survey of Liberant™ Thrombectomy System, also known as the Liberant Clinical Assessment, is to collect first-in-human clinical data to confirm the safety and performance of the Medtronic Liberant™ thrombectomy system when used for the removal of fresh, soft emboli or thrombi from the vessels of the peripheral arterial and venous systems