Peripheral Artery Disease (PAD)

Researchers are evaluating the safety and early effectiveness of an injectable drug called IMC-001 in improving the stability of atherosclerotic plaques in patients diagnosed with acute coronary syndrome (ACS), which includes conditions like acute myocardial infarction or unstable angina. This early phase 1, randomized, double-blind, placebo-controlled study is being conducted at two centers and aims to better understand how IMC-001 affects plaque stability in these patients. The study involves two dose groups with nine subjects each, where six receive IMC-001 plus optimal medical therapy and three receive a placebo plus optimal medical therapy. Participants will receive injections of either IMC-001 or placebo alongside standard treatments for coronary artery disease. The trial includes a dose escalation design to assess safety and preliminary efficacy. Participants will be monitored for changes in coronary artery low-attenuation plaque volume using coronary computed tomography angiography (CCTA) at baseline and again six months after treatment. The study will track safety, plaque volume changes, and other clinical assessments during the treatment and follow-up periods. The total participation duration includes the treatment phase and a six-month evaluation after dosing to assess the primary outcome measure.

Researchers are evaluating whether using an automated Carbon Dioxide (CO2) injection system during infrainguinal peripheral vascular interventions (PVI) can reduce major adverse kidney events within 90 days in patients at moderately increased risk for contrast-associated acute kidney injury (CA-AKI). This Phase 3 randomized controlled trial compares a CO2-based contrast medium sparing strategy to the standard use of iodinated contrast media in patients with peripheral vascular and kidney diseases. Participants are randomly assigned to one of two groups. The intervention group receives PVI using an automated CO2 injection system as the primary contrast agent, with iodinated contrast media available as a backup if image quality is insufficient or if the patient cannot tolerate CO2 angiography. The control group undergoes routine PVI using iodinated contrast media according to local standards, avoiding high-osmolar contrast agents. All patients are followed for up to 12 months after their procedure. During the study, participants undergo the planned PVI procedure with either contrast method. Researchers carefully record the amount and reasons for any iodinated contrast media used in the CO2 group. Patients are monitored for kidney-related outcomes, focusing on major adverse kidney events up to 90 days after the intervention. The trial includes ongoing follow-up assessments to evaluate safety and effectiveness over one year.

Researchers are evaluating a new therapy approach called MOBILE to improve walking ability in children and teens with Cerebral Palsy. This study aims to find out if the therapy is acceptable and helpful to both the children and their families when provided in a community setting. The key questions include whether participants tolerate the therapy, if families find it manageable, and if children complete all therapy sessions and assessments as planned over the course of the study. The therapy uses motor learning principles to target each child's specific walking goal. Participants will complete a total of 30 hours of therapy over 6 weeks, with at least 24 hours conducted in a clinic. The remaining hours can be done through a home program. This flexible format allows children to choose how they complete their therapy sessions while focusing on improving their walking patterns. During the study, children will be assessed before and after therapy to see if they meet their walking goals. Researchers will also interview participants about their experience with the therapy. Various outcome measures will be tracked over 2 years, including recruitment, adherence, retention, adverse events, fidelity to the intervention, and the acceptability of the therapy. Functional walking tests and quality of life assessments will be done at baseline, post-intervention, and at a 3-month follow-up. Participants are involved in therapy sessions, assessments, and interviews throughout the study period.

Researchers are conducting a multi-center clinical study to assess artificial intelligence (AI) algorithms for measuring heart function and size using echocardiography. The study aims to compare AI measurements with those of physicians at different experience levels, evaluate the accuracy and stability of AI, and explore its use in complex heart conditions like cardiomyopathy, valve disease, and coronary heart disease. The goal is to improve diagnostic consistency and clinical workflows across medical centers. The study involves measuring cardiac chamber size and function in 1600 participants using AI, senior physicians, and intermediate physicians. All measurements are made with Mindray ultrasonic machines. AI and intermediate physician results are completed within one day after data collection, while senior physician results are completed within one month. The study will establish a standardized reference system for AI-assisted echocardiographic measurements and evaluate AI's performance in special cases. Participants will undergo echocardiographic scans with measurements of left and right ventricular size and function, Doppler ultrasound indicators, and valve annulus displacements. Researchers will analyze data to compare AI and physician measurements, assess measurement deviations, and evaluate AI's efficiency in reducing analysis time. The study will run until July 2026, with ongoing data collection and analysis across multiple centers, aiming to promote wider clinical application of AI technology for cardiovascular disease diagnosis.

This research investigates the safety and performance of various Vascular Grafts, including FlowWeave Bioseal, FlowNit Bioseal, FlowLine Bipore, and FlowLine Bipore Heparin, in treating arterial diseases such as dissection, aneurysm, intramural hematoma, penetrating aortic ulcer, contained rupture, and stenosis affecting the aorta or peripheral arteries in the lower limbs. It also covers the use of these grafts for debranching head vessels and as arterio-venous shunts. The study is observational and focuses on patients who have already received these grafts. Patients included in this study have received one of these Vascular Grafts as part of their treatment for arterial conditions. The study collects data from routine care, including interventions like open repair of the aorta and peripheral arteries. The data collection period lasts approximately 60 months plus an additional 6 months beyond the last follow-up visit, depending on each patient's timeline. Participants' medical records and observations gathered during standard care visits will be used for data collection. Researchers will monitor outcomes such as 30-day mortality, longer-term mortality at intervals up to 60 months, graft-related adverse events, hemorrhage, stenosis or occlusion, graft patency, pseudoaneurysm formation, infections, sepsis, and stroke occurrences. Patients will be observed throughout this period while continuing their usual care, providing a comprehensive view of graft performance and safety over time.

Researchers are evaluating a preventive, multidisciplinary primary care intervention designed around a therapeutic garden to assess its acceptability among patients with cardio-neurovascular diseases. This study focuses on individuals suffering from various vascular conditions, including atrial fibrillation, heart failure (NYHA Class II), cardiomyopathies, ischemic stroke, and resistant hypertension. The main goal is to understand how patients and those involved in their care respond to this novel intervention. The intervention consists of a 6-month program that includes gardening activities, adapted physical exercise, nutritional workshops, and questionnaires to gather feedback. Participants may either take part in this multidisciplinary preventive action or choose not to receive the intervention but still complete questionnaires explaining their reasons. The study compares these two groups to identify acceptance rates and factors influencing participation. Participants will be involved for six months, during which their acceptance of the intervention and any obstacles or facilitators will be recorded. Researchers will assess the impact of the program through questionnaires and follow-up evaluations. The study monitors participants from enrollment through the end of treatment, aiming to gather comprehensive data on the intervention's feasibility and effects on patients with cardio-neurovascular conditions.

Researchers are investigating the safety and effectiveness of the Renzan14 Peripheral Stent System in treating patients with femoro-popliteal disease, a type of peripheral arterial disease affecting the leg arteries. This prospective, multicenter, single-arm study plans to include about 100 patients eligible for treatment with this stent. The study focuses on evaluating a modern nitinol stent designed for complex lesions where drug-coated balloons and drug-eluting stents may be less effective or raise concerns about toxicity. The Renzan stent is a self-expanding nitinol device pre-mounted on a catheter designed for precise placement in the affected arteries. It consists of two layers of braided nitinol wire mesh with radiopaque markers to assist in positioning during the procedure. The stent can be partly recaptured during placement if needed. This study observes patients undergoing endovascular implantation of the Renzan stent without comparison groups, focusing on the device's performance and safety after treatment. Participants will be followed for assessments of safety and effectiveness, including measurements at 30 days and up to 12 months after the procedure. Key evaluations include device and procedural success during implantation, rates of death, need for further treatment of the treated artery, artery openness, limb ischemia improvement, major adverse events, and limb amputation at multiple time points up to 36 months. Patients will be monitored closely with follow-up visits to track these outcomes and the long-term performance of the stent.

This research aims to evaluate two imaging strategies for treating patients with significant calcified coronary artery disease. The trial compares a calcium modification approach guided by coronary CT angiography (CCTA) to the current standard of care using intravascular ultrasound (IVUS)-guided percutaneous coronary intervention (PCI). The goal is to see if the CCTA method can improve procedural efficiency and effectiveness while maintaining similar clinical outcomes. Participants will be randomly assigned to one of two groups: one using CCTA to guide calcium modification and lesion assessment before PCI, and the other using IVUS for lesion evaluation and PCI guidance. The CCTA group uses advanced CT imaging to plan plaque modification, while the IVUS group follows established intravascular ultrasound criteria. Both groups undergo post-procedural IVUS to confirm correct stent placement. During the study, participants will undergo imaging evaluations such as CCTA and IVUS scans to assess lesion characteristics and stent results. Researchers will monitor procedural efficiency measures including procedure time, radiation exposure, and contrast use. Clinical outcomes like target vessel failure, myocardial infarction, and stent thrombosis will be tracked for up to 12 months. Patient-reported angina symptoms will also be collected to evaluate treatment impact. The total participation spans from pre-procedural planning through a 12-month follow-up.

Researchers are gathering detailed real-world information on people with chronic wounds and ulcers to better understand their medical journey and treatment outcomes. This observational registry collects data from over 1,400 healthcare providers across the USA and Puerto Rico using a specialized electronic health record system. It includes all major wound types such as diabetic foot ulcers, venous leg ulcers, pressure ulcers, arterial ulcers, surgical wounds, traumatic wounds, and inflammatory ulcers. Participants receive care as usual from their clinicians, who use standard and advanced wound treatments like specialized dressings, compression therapy, offloading devices, cellular and tissue-based products, negative pressure therapy, ultrasound therapy, topical oxygen, hyperbaric oxygen, growth factors, debridement, and topical antibiotics. Data on treatment practices, wound characteristics, patient health conditions, and complications are collected continuously during routine care. Patients may be followed for over five years to track long-term outcomes. During the study, researchers collect information on patient demographics, wound details, treatment methods, visit frequency, and complications. They monitor healing progress, amputations, deaths, wound recurrence, hospitalizations, and other outcomes. The registry uses a wound healing index to adjust for risk and supports quality improvement and research by linking clinical data with insurance claims for comprehensive analysis. This ongoing effort helps to better understand wound healing and treatment effectiveness in everyday healthcare settings.

Researchers are evaluating the long-term safety and effectiveness of the NOVA intracranial drug-eluting stent system in patients with intracranial atherosclerotic stenosis. This study is a prospective, multi-center, single-arm clinical trial conducted across about 50 centers in China, aiming to include 1000 participants who are suitable candidates for stent angioplasty. The trial will run from December 2022 to December 2030, focusing on patients with significant artery narrowing in the brain. All participants will receive the NOVA drug-eluting stent, which is designed to treat intracranial artery stenosis with a sirolimus-eluting coating and a rapid exchangeable balloon. The study includes ten visits starting from preoperative screening, the operation day, then follow-ups at 30 days, 3 months, 6 months, 1 year, and annually up to 5 years after the procedure. This schedule allows researchers to closely monitor the device's performance and patient outcomes over time. Participants will undergo various assessments during these visits, including evaluations for stroke, death, ischemic events, and revascularization related to the treated artery. Other measures include rates of stroke in different brain regions, transient ischemic attacks, restenosis, bleeding events, and quality of life assessments using tools like the modified Rankin Scale and EuroQol-5D. Safety, device defects, and long-term outcomes will be carefully tracked throughout the study period, which lasts up to five years after the operation.