Clinical Research Directory

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.

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).

Tele-assessment and Face-to-face Assessment of the 30-second Sit-stand Test in Peripheral Artery Disease

Peripheral artery disease (PAD) is a chronic and progressive condition caused by narrowing or blockage of arteries in the lower limbs due to atherosclerosis. It primarily affects adults over 50, with prevalence increasing with age, and its clinical presentation ranges from asymptomatic cases to severe ischemia that may require amputation. Intermittent claudication, characterized by exercise-induced leg pain that resolves with rest, is the most common early symptom. Impaired blood flow, poor vascularization, and muscle loss contribute to reduced lower limb strength and functional capacity, which are associated with higher morbidity and mortality. Walking exercises is a cornerstone of PAD management, particularly for patients with no or mild symptoms, making the assessment of lower limb strength and mobility essential for designing rehabilitation programs. The 30-second sit-to-stand test is a validated and practical measure of functional capacity and walking ability. Tele-assessment using video technology has been shown to be feasible and reliable in other patient populations. Although tele-rehabilitation has been widely studied and shown to improve functional outcomes, research on tele-assessment methods to accurately evaluate patient performance and the effectiveness of rehabilitation programs is still limited, particularly in PAD patients. This study aims to examine the reliability of the 30-second sit-to-stand test when performed via tele-assessment compared with face-to-face evaluation in patients with PAD.

The Efemoral Vascular Scaffold System (EVSS) for the Treatment of Patients With Symptomatic Peripheral Vascular Disease From Stenosis or Occlusion of the Femoropopliteal Artery

To evaluate the safety and performance of the EVSS in patients with symptomatic peripheral vascular disease from stenosis or occlusion of the femoropopliteal artery

Use of Shockwave M5+/L6 IVL Catheter (Intravascular Lithotripsy) in Hostile and Calcified Iliac Access

The study will evaluate, in a controlled setting, the efficacy and safety of the intravascular lithotripsy using Shockwave™ M5+/L6 Peripheral Intravascular Lithotripsy Catheter to facilitate delivery of aortic large-bore devices in iliac calcified access.

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.

Peripheral Extreme Revascularization in "No-option" Patiens With Chronic Limb Threatening Ischemia

The objective of the study is to evaluate early safety and effectiveness of the percutaneous deep foot venous arterialization performed in clinical practice, in an unselected population of patients with "no-option" CLTI.

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.

SIGNATURE Study : DCB (Legflow) vs POBA in Fempop Arteries

The aim of this study is to demonstrate the superiority in safety and efficacy of the Legflow DCB vs standard uncoated POBA in a randomized controlled (RCT) for treatment of patients with symptomatic peripheral artery disease (PAD) due to stenosis, restenosis or occlusion of the femoral and/or popliteal arteries.

Intravascular Ultrasound Imaging Guidance for Optimal Revascularization of Limb Arteries

This study will test whether using ultrasound imaging within blood vessels during minimally invasive treatment of leg arteries in patients with peripheral artery disease leads to better clinical outcomes.

Auryon Atherectomy System With Standard Balloon Angioplasty Versus Standard Balloon Angioplasty Alone in Europe

The goal of this clinical trial is to learn if the Auryon Atherectomy System with balloon angioplasty safe and effective in treating lower limb blockages. The main question it aims to answer is: Is treatment with Auryon Atherectomy System more effective than angioplasty alone in preventing death, amputation, revascularization and improving patency? Researchers will compare the Auryon Atherectomy System with balloon angioplasty to balloon angioplasty alone.

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.

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.

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.

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

CT Body Composition as Predictor of Exercise Therapy Outcome in Peripheral Arterial Disease

Supervised exercise therapy (SET) is the recommended first treatment for patients with leg artery disease (peripheral arterial disease, PAD) causing pain when walking. However, approximately 40% of patients do not benefit meaningfully and go on to require a procedure to open the blocked arteries within three months. This study investigates whether body composition measurements - specifically the quality of muscle and the amount of belly fat - taken from a CT scan already performed as part of routine care, can identify before treatment begins which patients are unlikely to respond to exercise therapy. If confirmed, this approach would allow doctors to use information from a scan patients are already having, with no additional tests, to better match patients to the right treatment from the start.

MitoQ Treatment of Claudication: Myofiber and Micro-vessel Pathology

In our research, we are delving into whether taking MitoQ for six months can improve the symptoms and function of people diagnosed with peripheral artery disease, especially those who suffer from leg pain while walking, known as intermittent claudication. We will be checking if MitoQ helps people with claudication walk better, be more active every day, feel better about their lives, and if it enhances the health of their leg muscles.

Road Mapping Guided Puncture Versus Ultrasound Guided Puncture During Retrograde Angioplasty Feasibility and Safety

The study aims to compare the technical feasibility and safety of road mapping-guided versus ultrasound-guided retrograde arterial puncture in patients with (CLTI) as measured by: * Puncture success rate * Access-related complication rate (e.g., hematoma, vessel dissection, perforation)

Major Adverse Limb Events in Patients With Femoro-popliteal and Below-the-knee Peripheral Arterial Disease Treated With Either Sirolimus-coated Balloon or Standard Uncoated Balloon Angioplasty

The SirPAD trial is an academic, investigator-initiated, single-center, randomized, non-inferiority, open-label clinical trial investigating whether the use of sirolimus-coated balloon catheters in patients with peripheral artery disease of the femoro-popliteal or below-the-knee segment is not inferior to that of uncoated balloon catheters for major clinical outcomes (unplanned major amputation, target limb re-vascularization) and may provide advantages concerning important secondary outcomes, which will be evaluated using a pre-specified hierarchical order as part of the primary analysis.

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.

Near Infrared Spectroscopy Imaging of Change in Tissue Oxygenation to Assess Peripheral Artery Disease

This is a proof-of-concept study with exploratory objective to assess whether superficial tissue oxygenation patterns measured by Snapshot NIRS, in conjunction with the Provocative Elevation Maneuver of the Lower Extremity (PEMLE) and/or the Plantar Palmar Index (PPI), are associated with the severity of peripheral arterial disease (PAD) as determined by standard of care assessments and can be used to assess tissue oxygenation after revascularization, where applicable.

Randomized Clinical Trial for Ewing Amputation in the VA

This study follows the Pilot Investigation of Ewing Amputation for Veterans with PAD Undergoing a Below Knee Amputation. The 2 year pilot feasibility phase has concluded recruitment and enrollment. The current phase is a 5 year randomized study of Ewing Below Knee Amputation vs. Standard Below Knee Amputation. If Veterans participate, they will be randomized to either Ewing Amputation or Standard Below Knee Amputation. The scientific premise motivating this proposal is that Ewing Amputation is a promising surgical technique that may improve walking metrics in dysvascular Veterans by providing a better residual limb and improving pain and balance. In preparation of this proposal, we have formed multi-disciplinary surgical teams at each site, and we have been supported by a clinical trial planning meeting to garner the considerable expertise in rehabilitation and amputee assessment from VA and DOD experts to assist in the design of this proposal, testing the overall hypothesis that: Ewing Amputation can help Veterans walk.

Multi-Center Registry for Peripheral Arterial Disease Interventions and Outcomes

XLPAD is an observational study designed to evaluate the effectiveness and use of stent and non-stent based therapies among PAD patients. The study will create a registry that will include entry of procedural and clinical follow-up information into an online data collection software, REDCAP.Data available since Jan 1 2005 will be included in the registry, until 14,000 patients have been included. The primary objectives of this observational registry study are to: 1. Compare stent and non-stent based outcomes defined as a composite of symptom driven target vessel revascularization (TVR), unplanned surgical revascularization of the target limb and need for target limb amputation through 12 months post-index procedure (Primary efficacy endpoint) 2. Compare stent and non-stent based outcomes defined as a composite of causes such as: death, myocardial infarction (MI), stroke, peri-procedural complications, target vessel revascularization (TVR) and unplanned surgical revascularization/amputation of the target limb through 12 months (Primary safety endpoint) 3. Compare stent and non-stent based change in walking distance, Rutherford category and/or ankle- brachial index (ABI) at 12 months compared to baseline (Primary clinical improvement endpoint) Approximately 14,000patients will be enrolled at approximately 60 sites worldwide. Enrollment in the observational study will be monitored in an effort to achieve at least 20% (and no more than 80%) of the population receiving stents as the initial treatment strategy. Follow-up visits by sites will be reported at 6 and 12 months after index procedure to collect data on treatment patterns and effectiveness, and outcomes. The follow-up procedures are not mandated by the registry protocol. Each site will be encouraged to enter follow-up information derived from clinically indicated follow-up visits. All events post-index procedure till the 7th month will be reported under the 6 month follow-up form and subsequent follow-up till the 13th month post-procedure will be entered on the 12 month follow-up form. Patient management and treatment decisions are at the discretion of the care team per routine clinical practice. The procedural aspects (including selection of stent type or non-stent based treatments) and follow-up are not mandated by the registry and will be up to the discretion of the operator and/or based upon the practice dictated by the clinical care of the patient. Therefore the study poses minimal risk to the patient.

SELUTION4BTK Trial

This study aims to demonstrate superior efficacy and equivalent safety of the SELUTION SLR™ DEB 014 compared to plain (uncoated) balloon angioplasty in the treatment of peripheral arterial disease (PAD) in the BTK arteries in CLTI patients.