Buerger's Disease

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 the safety and effectiveness of the Auryon Atherectomy System combined with balloon angioplasty compared to balloon angioplasty alone in treating blockages in the lower limbs, specifically in patients with critical limb ischemia. The study aims to determine if using the Auryon system improves outcomes such as reducing death, amputation, and the need for additional procedures while maintaining blood vessel openness. Participants will be randomly assigned to one of two groups: one group will receive treatment with the Auryon Atherectomy System followed by balloon angioplasty, while the other group will receive balloon angioplasty alone. The Auryon system includes a laser and catheter device. The trial includes an observational study for patients who do not meet the criteria for randomization but are treated with the Auryon system. Treatments and follow-up extend up to 24 months after the procedure. Throughout the study, participants will undergo various assessments including imaging tests like duplex ultrasound at hospital discharge, and at 30 days, 6, 12, and 24 months. Researchers will measure clinical improvements, limb amputation rates, blood flow indexes, wound healing, quality of life, and major adverse limb and cardiovascular events. The primary outcome compares groups on a combined set of measures at 12 months. Safety and device success are also monitored during and after the procedures.

This research aims to collect Real-World Data on the treatment of lesions in the peripheral vasculature, focusing on populations not well represented in previous Peripheral Vascular Disease trials. It evaluates the safe use of commercially available drug-eluting devices made by Boston Scientific Corporation. The study is an observational, multi-center registry that includes health economics data to better understand treatment outcomes in everyday clinical settings. Participants will be treated with any eligible commercially available Boston Scientific drug-eluting device, such as the Ranger14 Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter or the ELUVIA14 Drug-Eluting Vascular Stent System. All enrolled patients form the Clinical Cohort, completing assessments per usual care for up to 2 years in most countries and 5 years in China. Some patients at select sites will also join the Outcomes Cohort, which includes extra assessments like Quality of Life questionnaires, the six-minute walk test, and healthcare use data collection. During the study, participants will undergo regular clinical assessments following standard care practices. Researchers will monitor major adverse events and lesion patency at 12 months as primary outcomes. Additional data on quality of life and walking ability will be collected in the Outcomes Cohort. The study follows participants for up to five years depending on location, ensuring long-term monitoring of device use and patient health outcomes.

Researchers are evaluating the safety and effectiveness of intramuscular administration of Stempeucel (adult human bone marrow-derived, cultured, pooled, allogeneic mesenchymal stromal cells) in Malaysian patients with critical limb ischemia (CLI) caused by Buerger's disease. This observational, practice-based feasibility study aims to see if Stempeucel can reduce CLI symptoms, improve ulcer healing, and enhance functional outcomes while monitoring for any serious adverse events. The treatment involves a single arm where Stempeucel cells are supplied in cryo-bags containing 150 or 200 million cells suspended in a liquid mixture. The dose is based on body weight, with injections administered intramuscularly into various points on the muscles, including additional injections around the ulcer. The study is planned to last approximately 18 months, with treatment and follow-up occurring during this period. Participants will be assessed before treatment and monitored over one year after administration for safety and effectiveness. Evaluations include measurement of ischemic rest pain, ulcer size, ankle brachial pressure index, walking distance, amputation-free survival, and angiogenesis at multiple time points up to 360 days. Safety assessments involve tracking adverse events, laboratory tests, vital signs, physical exams, ECGs, and chest condition, with data recorded electronically for analysis.

This research investigates how oxidants, substances in the blood that may harm blood vessels, affect blood vessel function in healthy people and those with mental health disorders like posttraumatic stress disorder (PTSD) and generalized anxiety disorder (GAD). The goal is to better understand vascular health in these groups and the role of oxidants. The study is an interventional trial with randomized and quadruple masking design. Participants take part in three separate sessions over about two weeks at the Exercise Physiology Research Laboratory. In the first visit, they become familiar with the study equipment and procedures, have body measurements taken, forearm and calf strength tested, and provide a blood sample. In visits two and three, lasting 2-3 hours each, they receive either antioxidant pills or placebo pills in a randomized order to assess how these affect blood vessel health. During the study, researchers measure arm and leg vascular function at rest and in response to exercise using tests such as flow-mediated dilation, passive leg movement, and handgrip exercise tests. These assessments occur from baseline through the final visit over roughly two weeks. The study monitors the effects of antioxidant versus placebo intake on blood vessel function to understand vascular health in individuals with and without mental health disorders.

This research aims to study how different exercise training programs affect blood vessel function in healthy adults and those with mental health disorders such as posttraumatic stress disorder (PTSD) and generalized anxiety disorder (GAD). The study focuses on understanding vascular dysfunction related to these conditions by comparing exercise impacts in these groups. The study involves seven visits over about 14 weeks at the Exercise Physiology Research Laboratory. Initial visits include familiarization with study equipment, body measurements, strength tests, and blood draws. Participants receive antioxidant or placebo pills on two separate visits to evaluate oxidants' effects on blood vessels. They undergo a 10-week exercise training program varying by intensity and frequency: moderate intensity normal volume, high intensity normal volume, or moderate intensity high volume treadmill running. Participants will complete various vascular health tests, including flow mediated dilation, passive leg movement, and handgrip exercise tests, before and after exercise training. The study includes monitoring body composition, strength, and blood samples. Researchers track changes in arm and leg vascular function from baseline through the final visit. The entire process takes about 14 weeks, with multiple testing days to assess endurance, strength, and vascular response.

This research explores how different types of exercise training affect blood vessel function in healthy adults and those with mental health conditions such as posttraumatic stress disorder (PTSD) and generalized anxiety disorder (GAD). The study aims to understand vascular health changes related to these conditions by comparing the effects of exercise training. It is an interventional study conducted by Virginia Commonwealth University, involving randomized groups and multiple testing sessions. Participants undergo a series of five testing sessions spread over about 14 weeks. The first session introduces the study procedures and collects body measurements and blood samples. Two sessions test blood vessel health after participants receive either antioxidant or placebo pills in a randomized order. After these baseline tests, participants complete 10 weeks of resistance training, three to five days per week, in one of two groups: muscular strength training with heavier weights or muscular fitness training with moderate weights. Additional testing before and after the training assesses endurance, strength, and vascular function. During the study, participants will have their blood vessel function measured at rest and in response to exercise using tests such as flow mediated dilation, passive leg movement, and handgrip exercise. They will complete questionnaires assessing mental health symptoms and have strength and endurance evaluated. Researchers monitor changes from the start to the end of the study, which lasts about 14 weeks. Safety and adherence are tracked throughout the trial, with all assessments conducted in a controlled laboratory setting.

Researchers are conducting a pilot randomized trial to study whether Fisetin, a natural flavanol found in fruits like strawberries and apples, can reduce the number of aging cells (senescent cells) in blood, muscle, and fat tissues of people with peripheral artery disease (PAD). The study also aims to see if reducing these cells improves walking ability measured by the six-minute walk test. Additionally, the trial will explore if Fisetin lowers inflammation markers such as interleukin-6 and other senescence-related markers. Participants aged 50 and older with PAD will be randomly assigned to receive either Fisetin or a placebo. The treatment involves taking Fisetin or placebo capsules at a dose of 20 mg per kg of body weight once daily for two days, followed by 12 days without treatment, repeated over a four-month period. The capsules are provided in 100 mg tablets, with dosing rounded to the nearest 100 mg. During the study, participants will undergo assessments at the start and after four months, including tests of walking distance, hand grip strength, physical performance, muscle blood flow, and cell markers of aging. Researchers will monitor these measures to evaluate changes and safety throughout the trial period. The total study duration for each participant is four months, during which their health and response to the treatment will be closely followed.

Peripheral artery disease (PAD) affects millions worldwide and involves the narrowing of arteries in the legs and back, leading to muscle pain during exercise and serious complications such as ulcers and gangrene. This study aims to evaluate whether acute intake of diroximel fumarate (Vumerity) can improve antioxidant capacity, reduce oxidative stress, and enhance both vascular function and walking ability in people with PAD. Researchers are testing this by comparing diroximel fumarate with a placebo in participants with PAD and healthy controls. Participants will receive a single dose of either diroximel fumarate or a placebo, followed by the alternate treatment after at least 7 days. The study uses a randomized, double-blind design with crossover between treatments. Vascular and walking function will be assessed using methods such as flow-mediated dilation, arterial stiffness measurement, head-up tilt testing, blood biomarkers, near-infrared spectroscopy, and treadmill walking tests. A follow-up visit will evaluate blood work after diroximel fumarate intake. During the study, participants will undergo assessments before and after each intervention dose on two separate days. These assessments include measures of macrovascular endothelial function, oxygen transfer and use, artery blood flow, and walking capacity. Researchers will monitor blood markers of oxidative stress and antioxidants. The study includes safety monitoring and aims to understand the acute effects of diroximel fumarate on vascular health and physical function in PAD. Total participation time includes initial dosing visits and a follow-up blood evaluation visit.

This research aims to assess the long-term safety and performance of Intervascular Vascular Grafts and Patches, including Intergard Standard, Hemashield, Intergard Silver, and Intergard Synergy, used for bypass, repair, or replacement of aortic, peripheral, or carotid arteries. The study focuses on evaluating the product lifetime and the usefulness of antimicrobial coatings on these devices. The registry collects data from patients who have undergone these specific vascular procedures. Participants receive one of the Intervascular vascular grafts or patches, which vary by type and coating. The devices include collagen-coated grafts designed to reduce bleeding and antimicrobial-coated grafts intended to prevent infections. The study includes different patient groups based on the affected artery: Peripheral Arterial Disease, Aortic Disease, and Carotid Artery Disease cohorts. Data collection extends from the time of surgery through an anticipated average follow-up of five years. During the study, researchers collect data from medical records to monitor device patency, incidence of adverse events such as limb events or infections, and technical success rates. Follow-up includes tracking changes in clinical measures like the Rutherford Category and Ankle-Brachial Index for peripheral artery patients. The registry observes participants over at least three years and up to approximately five years to understand long-term outcomes and device performance in real-world use.