Clinical Research Directory

Safety of Antithrombotic Heparin Proteoglycan Mimetic APAC in Peripheral Arterial Occlusive Disease and Chronic Limb-threatening Ischemia

The goal of this study is to learn if a new medicine (called antiplatelet and anticoagulant \[APAC\]) can help the body to prevent blood clots and whether APAC is safe and well tolerated in patients with blocked or narrowed arteries in their legs (peripheral arterial occlusive disease \[PAOD\]), and in patients with severely restricted poor blood flow to the legs that threatens limb health (chronic limb-threatening ischemia \[CTLI\]). The study also aims to find the best dose of the medicine. The study consists of two parts: Part A will include patients with PAOD and CTLI, Part B will only include patients with CTLI who are having a procedure to restore blood flow in their legs. Both parts will be subdivided into two subgroups (A1 and A2, B1 and B2) which will test different APAC doses and compare single dosing to weekly dosing for 4 weeks. APAC is injected into the blood. The possible treatment response will be compared either to a placebo (a look-alike substance that contains no drug), or to the current standard treatment. Patients will participate in the study for up to 90 or 180 days. During this time, patients will be regularly examined and asked to answer questions concerning their quality of life.

Woundsome Revascularization in Chronic Limb-Threatening Ischemia

Chronic limb-threatening ischemia (CLTI) is the most severe form of peripheral artery disease and remains a major health problem. Although the angiosome concept was introduced to guide revascularization by restoring direct blood flow to the affected tissue, its usefulness is limited by anatomical variations, collateral circulation, and wounds involving multiple territories. The emerging "woundsome" concept focuses instead on improving arterial perfusion directly to the wound area, recognizing that both direct revascularization and

Esprit BTK Post-Approval Study

The Esprit BTK PAS is a prospective, single-arm, multi-center observational study to assess the continued safety and effectiveness of the Esprit™ BTK Everolimus Eluting Resorbable Scaffold System under commercial use, in patients with diseased infrapopliteal lesions causing CLTI (Chronic Limb-Threatening Ischemia) in a real-world setting. The clinical investigation will be conducted at up to 50 sites in the United States (US) and additional sites may be added outside of the US (OUS). Approximately 200 patients with a minimum of 50% of patients in the US will be registered in the clinical investigation.

Pivotal Trial of the Boomerang Catheter for pDVA

The purpose of this study is to establish the safety and effectiveness of the Boomerang Catheter for percutaneous Deep Venous Arterialization (pDVA) to treat no-option Chronic Limb-Threatening Ischemia.

Bioresorbable Sirolimus-Eluting Scaffold Treatment for Below the Knee Disease

The objective of this prospective, single-blinded, randomized controlled trial is to evaluate the safety and efficacy of the MAGNITUDE BRS System for the planned treatment of narrowed infrapopliteal lesions. Approximately 276 subjects will be randomized in a 1:1 ratio. The clinical investigation will be conducted at up to 60 clinical sites globally.

Expression of GLP1 Receptor on Peripheral Blood Mononuclear Cells in Advanced Peripheral Artery Disease: Paving the Way for GLP1R Agonists Treatment in Chronic Limb Threatening Ischemia

The goal of this observational study is to learn whether activation of the GLP-1 receptor could represent a therapeutic target by characterizing its expression and associated inflammatory mechanisms in patients with peripheral artery disease, according to disease severity, in adults with symptomatic lower-limb peripheral arterial disease. The main questions it aims to answer are: * Is the level of GLP-1 receptor (GLP1R) expression on peripheral blood mononuclear cells (PBMC) different between patients with intermittent claudication (ischemia of effort) and those with chronic limb-threatening ischemia? * Is GLP1R expression associated with inflammatory and oxidative profiles of PBMC? * Can GLP-1 receptor agonists reverse inflammatory and oxidative alterations induced by plasma from patients with peripheral artery disease in endothelial cell cultures? * Are there specific plasma proteomic signatures associated with GLP1R overexpression? Researchers will compare patients with intermittent claudication to patients with chronic limb-threatening ischemia to see if disease severity is associated with differences in GLP1R expression, PBMC inflammatory/oxidative phenotype, and plasma proteomic profiles. Participants will: * Provide an additional blood sample (15 mL) collected during a routine, clinically indicated blood draw * Have PBMC isolated for measurement of GLP1R expression and assessment of inflammatory and oxidative markers * Have plasma analyzed for proteomic profiling and used in in-vitro endothelial cell experiments Participation ends after completion of the blood sampling, and no additional procedures beyond standard clinical care are required.

Chronic Wounds and Blood Circulation Detection

Lower limb circulatory insufficiency and the associated chronic wounds are common health problems among the elderly. These issues not only affect the individual's mobility and quality of life but also potentially increase medical costs and caregiving expenses. Traditional treatment methods often employ medications to enhance blood circulation, but these clinical approaches have limited effectiveness and induce the risk of side effects. Utilizing exercise as an intervention strategy can help improve lower limb blood circulation in the elderly while reducing the side effects associated with medications. However, due to physical frailty, elderly individuals often cannot participate in high-intensity exercises to improve their circulatory performance. Therefore, this study will develop a lower limb circulation enhancement exercise system to improve the circulatory performance in individuals with poor lower limb circulation. It will compare the effects of lower limb circulation enhancement exercise, vibration exercise, and mixed exercise on improving blood circulation and functional performance in the elderly or individuals with poor lower limb circulation. Participants will be randomly assigned into three groups: the lower limb circulation enhancement exercise group, the vibration exercise group, and the mixed exercise group. In addition, a separate group of young adults (control group) will serve as a reference for baseline comparisons. Initially, all participants will undergo a one-time exercise test, followed by a 12-week intervention. The lower limb circulation enhancement exercise group will perform a 30-minute leg press rowing exercise three times a week, while the vibration exercise group will engage in vibration exercise at the same frequency, and the mixed exercise group will perform group-based mixed exercise training at the same frequency. The young adult control group will not receive any intervention but will undergo the same assessments. Outcome evaluations before and after the intervention include lower limb blood perfusion monitoring, pain scales, and functional performance assessments.

ORbital Atherectomy for Lesion Preparation in Patients With Chronic Limb-threatening ischEmia

ORACLE is a Europe-wide study that will follow 250 people with critical limb-threatening ischemia (CLTI). It aims to see how well orbital atherectomy (OA) works in real-life practice. OA is a procedure that uses a tiny spinning tool to gently remove hard calcium from inside an artery, helping to open the vessel so other treatments-like balloons or stents-can work better. The study focuses on people who have heavily calcified arteries in the femoropopliteal or infrapopliteal areas of the leg.

Chronic Limb-Threatening Ischemia Treated With Intravascular Lithotripsy Observational Study

CALCIO is a multicentre, prospective, observational cohort study that will collect real world data on the use of intravascular Lithotripsy (IVL) with the Shockwave IVL system to disrupt calcified femoropopliteal and crural lesions in patients with chronic limb-threatening ischemia (CLTI). The primary objective of CALCIO is to understand the effectiveness of IVL in promoting wound healing and preventing amputation. The secondary objectives of CALCIO are to evaluate the immediate effectiveness of the treatment in restoring vessel patency as well as its safety and impact on patients' quality of life.

REsorbable SCaffolds With everolimUs-Elution for the Treatment of Infrapopliteal Artery Disease in Patients With Chronic Limb-threatening Ischemia

RESCUE is a Europe-wide study that will follow 400 people with critical limb-threatening ischemia (CLTI). It aims to see how well Esprit BTK™ Everolimus Eluting Resorbable Scaffolds work in real-life medical settings. The study focuses on people who have heavily calcified arteries in the infrapopliteal areas of the leg. These drug-eluting resorbable scaffolds release a medication that helps prevent the inner wall of the blood vessel from thickening after injury or surgery. This can reduce the chance of the artery becoming blocked again (a problem called restenosis), while also giving temporary structural support to the vessel. Over time, the scaffold naturally dissolves in the body, which may lower the long-term risks associated with permanent metal stents.

Pressure Wire Guidance for Infrapopliteal Artery Interventions

"• A prospective, single-center randomized controlled comparison trial. * A total of 100 patients with symptoms of chronic limb-threatening ischemia (Rutherford category 5) undergoing endovascular treatment for anterior tibial artery or posterior tibial artery lesions will be included if they meet the inclusion criteria and do not meet any exclusion criteria. * Patients will be randomized in a 1:1 open-label manner either to the pressure wire-guided group or the angiography-guided group. * Patients will be treated with balloon angioplasty for anetrior tibial artery or posterior tibial artery lesions. * In the angiography-guided group, balloon angioplasty will be performed to achieve an optimal procedural result, as determined by angiography. Optimal results are defined as antegrade blood flow without residual stenosis \>50% or flow-limiting dissection. * In the Pressure Wire-guided gorup, balloon angioplasty will be performed to obtain optimal procedural result based on both angiography and a pressure gradient over the target lesion. Optimal pressure gradient is less than 10 mmHg by measurement using a Pressure Wire. * The primary efficacy endpoint is defined by attaiment of skin perfusion pressure ≥50 mmHg within 1-3 days after the index procedure. * Patients will be followed at 1, 3, and 6 months after the procdure to assess wound healing status, and clinical events."

Peripheral Bypass Trial for Completion Control

The goal of the study is to identify and validate flow measurement and ultrasound images in patients undergoing vein bypass surgery below-knee and above ankle

The PORTuguese Registry of Supera Supported Femoral-Fopliteal Revascularization (SupPORT Registry)

The SupPORT Registry aims at collecting real-world from Portuguese centers performing femoral-popliteal revascularization with Supera (r) implants. This is a prospective non-randomized non-controlled consecutive registry.

AcoArt Litos PCB Below-the-knee Global Trial

The objective of this study is to assess whether efficacy of the AcoArt Litos PCB is superior and whether safety of AcoArt Litos PCB is noninferior to the control device (FDA cleared PTA Balloon Catheter) regarding treatment of obstructions in the infrapopliteal arteries (located distal to the P3 segment of the popliteal artery and extending to the tibiotalar joint) in patients presenting with chronic limb-threatening ischemia (CLTI)(Rutherford 4-5)

The ROAMM-EHR Study

In recent years, mobile health (mHealth) apps have promised improved monitoring of health conditions to improve clinical outcomes. The objective of this study is to conduct a pilot randomized clinical trial (RCT) to evaluate the impact of using remotely collected patient generated health data (PGHD) from older patients undergoing bypass surgery due to chronic limb threatening ischemia. The hypothesis is that integrating PGHD with an EHR system will help providers manage post-surgical symptoms and thus improve post-operative mobility and quality of life health outcomes.

BGC101 (EnEPC) Autologous Cell Therapy From Patient's Own Blood for Treatment of Critical Limb Ischemia (CLI)

Evaluate the feasibility of an autologous cell preparation composed of a mixture of cells enriched for endothelial progenitor cells (EnEPCs) and multipotent adult hematopoietic stem/progenitor cells (HSPC) (BGC101), in the treatment of patients suffering from peripheral arterial disease (PAD) with critical limb ischemia (CLI) who have not responded to optimal pharmacological treatment or control of risk factors and/or had a revascularization failure, and do not have the option of further revascularization treatment.

Radiotracer-Based Perfusion Imaging of Patients With Peripheral Arterial Disease

The aim of this clinical study is to 1) establish a healthy database for nuclear perfusion imaging of the lower extremities and 2) assess the prognostic value of radiotracer-based perfusion imaging for predicting clinical outcomes in patients with peripheral artery disease (PAD) who are undergoing lower extremity revascularization procedures. We hypothesize that radiotracer imaging of the lower extremities will provide a sensitive non-invasive imaging tool for quantifying regional abnormalities in skeletal muscle perfusion and evaluating responses to medical treatment.

Agreement Study on AI-assisted Smartphone-based Monitoring Tool for Difficult-to-heal Ischemic Leg Ulcers

The purpose of the project is to investigate the agreement with Bland-Altman plots between an AI-supported automatic digital measurement method of wound area and depth and existing manual measurement methods in patients with arterial ulcers on the lower leg. The expectation is that the digital measurement tool can provide healthcare providers with better opportunities to objectively monitor and detect changes in the wound healing process in patients with peripheral arterial disease.

PROMISE III: Percutaneous Deep Vein Arterialization for the Treatment of Late-Stage Chronic Limb-Threatening Ischemia

A prospective, single-arm, multi-center study designed to gather additional information on the LimFlow System.

Use of CPETarm for Risk Stratification of Patients With CLTI

This is a prospective cohort study of patients undergoing surgery for chronic limb threatening ischaemia. Prior to surgery, patients will undergo CardioPulmonary Exercise testing (CPET) using an arm ergometer. Feasibility outcome measures will be recorded at testing and participants will be followed up for a period of up to 5 years to obtain clinical outcome measures.

Thermovision-controlled Lumbar Sympathetic Blockade in Chronic Limb-threatening Ischemia Treatment

Thermovision-controlled lumbar sympathetic blockade in chronic limb-threatening ischemia treatment