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.

Researchers are collecting Real-World Data to better understand treatment outcomes and health economics related to lesions in the peripheral vasculature. This global, prospective, non-randomized, open-label, multi-center Registry aims to include populations not well represented in previous Peripheral Vascular Disease trials. The study supports the safe use of commercially available Boston Scientific drug-eluting devices for this condition. Participants receive treatment using any eligible commercially available Boston Scientific drug-eluting device, such as the Ranger Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter or the ELUVIA Drug-Eluting Vascular Stent System. The study includes two cohorts a Clinical Cohort, where patients undergo standard of care assessments with follow-up for up to 2 years in multiple countries and 5 years in China, and an Outcomes Cohort at select sites with additional evaluations including Quality of Life questionnaires, six-minute walk tests, and healthcare utilization data collection. During the study, participants complete various assessments according to standard care and additional tests depending on their cohort. Researchers measure major adverse events and lesion patency at 12 months to evaluate outcomes. The study monitors participants through follow-up visits extending up to 5 years to gather safety and effectiveness data in real-world clinical practice.

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 Buergers 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 study explores how oxidants, which are substances produced in the blood that can harm blood vessel function, affect blood vessels in healthy adults and those with mental health disorders such as posttraumatic stress disorder PTSD and generalized anxiety disorder GAD. The study aims to better understand the role these oxidants may play in blood vessel health across these groups. Participants will take part in three separate study sessions over about two weeks at the Exercise Physiology Research Laboratory. During the first visit, they will become familiar with the study procedures, have body measurements taken, strength tested, and provide a blood sample. In the following two visits, lasting 2 to 3 hours each, participants will take either antioxidant pills or placebo pills in a randomized order to assess the effects on blood vessel function. Throughout the study, participants will undergo tests to evaluate blood vessel health in the arms and legs, including blood flow and response to exercise. Researchers will measure vascular function before and after the interventions using tests like the Flow Mediated Dilation and Passive Leg Movement tests. The study includes safety monitoring and will last about two weeks from the initial visit to the final assessments.

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 many people worldwide and involves narrowed arteries in the legs and back, causing muscle pain during exercise and serious complications like ulcers and amputation. This study aims to see if taking a drug called diroximel fumarate Vumerity can improve blood vessel function and walking ability by reducing oxidative stress, which is believed to worsen PAD. Researchers will assess how this drug affects blood flow and muscle function in individuals with PAD compared to a placebo. Participants will receive a single dose of diroximel fumarate or a matching placebo, then after at least seven days, they will switch to the other treatment in a randomized crossover design. The study evaluates the immediate effects of diroximel fumarate on vascular function and walking capacity. Tests include measuring artery dilation, stiffness, blood flow, muscle oxygen use, and walking ability on a treadmill. A follow-up visit will check blood markers several days after treatment. During the study, participants undergo various assessments such as flow-mediated dilation tests, arterial stiffness measurements, blood biomarker collection, near-infrared spectroscopy, and a treadmill walking test both before and after each treatment. The main outcomes measured are blood vessel function, oxygen use, blood flow, and walking capacity. Safety and antioxidant blood markers will also be monitored. The study includes adults aged 50 to 75 and spans approximately two visits with a washout period between treatments.

This registry study is designed to monitor the long-term safety and performance of several Intervascular Vascular Grafts and Patches, including Intergard Standard, Hemashield, Intergard Silver, and Intergard Synergy. These devices are used for bypass, repair, or replacement of aortic, peripheral, or carotid arteries. The study aims to better understand the expected lifespan of these products and assess the usefulness of their antimicrobial coatings. Participants have previously undergone vascular procedures using these grafts or patches. The study observes patients across three groups based on their treated artery type Peripheral Arterial Disease, Aortic Disease, and Carotid Artery Disease cohorts. Devices with antimicrobial coatings such as silver acetate and triclosan are also evaluated to track infection prevention. Data collection spans an anticipated average of five years following the surgical procedure. Throughout the study, participants medical records are reviewed to assess outcomes such as device patency, freedom from occlusion or reintervention, incidence of major adverse events, infections, technical success, and changes in vascular health indicators. This observational registry does not involve active treatment but collects long-term safety and performance data. The study is expected to continue until December 2026, with participants contributing data over multiple years post-procedure.