Intermittent Claudication

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 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.

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 safety and effectiveness of the Supera Vascular Mimetic Implant for treating narrowing or re-narrowing (stenosis or restenosis) in the common femoral artery in patients with moderate to severe peripheral arterial disease classified as Rutherford categories 2 to 4. This trial compares the implant to traditional surgical endarterectomy, aiming to see if the implant is at least as effective and safer. The study is randomized and involves patients whose medical condition is stable enough for testing and follow-up. Participants are randomly assigned to receive either the Supera Peripheral Stent System, an endovascular device with a special interwoven design that resists crushing and treats calcified plaques, or undergo classic surgical endarterectomy. Before the procedure, patients undergo tests including blood work, ankle or toe-brachial index measurements, and a walking questionnaire. The implant procedure involves crossing the lesion with a guidewire, balloon pre-dilatation, and stent placement. Surgical patients receive standard care for endarterectomy. Follow-up visits are scheduled at 1, 6, 12, 24, and 36 months after the procedure. During follow-up visits, researchers collect data on medication, physical exams, blood flow indexes, ultrasound of the treated vessel, walking ability, and any complications or adverse events. The main outcomes measured include the success of the treatment in keeping the artery open at 12 months and safety events within 30 days after the procedure. Secondary outcomes include artery patency, revascularization rates, changes in walking ability and limb condition, hospital stay length, and survival up to three years. The total participation duration includes these regular follow-ups over 36 months.

Researchers are evaluating the effects of SRSD107 in adults with chronic coronary artery disease (CAD) and/or peripheral arterial disease (PAD). This Phase 2a study aims to understand how multiple doses of SRSD107 affect the body (pharmacodynamics), how the body processes the drug (pharmacokinetics), and its safety when used alongside aspirin therapy. The trial uses a randomized, double-blind, placebo-controlled design with several sequential groups to carefully assess these factors. Participants will receive subcutaneous injections of SRSD107 at different dose levels or a placebo. The study includes five groups: four experimental dose levels of SRSD107 and one placebo group. All treatments are administered under close monitoring to assess drug levels and effects over time. Throughout the 72-week study period, participants will have regular assessments including blood tests to measure FXI antigen levels, FXI activity, and clotting times (aPTT). Researchers will also track how much SRSD107 is present in the blood, the timing of peak concentrations, and any adverse events. Safety and drug effects will be carefully monitored to understand how SRSD107 works in this patient population.

Researchers are conducting a prospective, multicenter, randomized trial to assess the effectiveness and safety of the Sperstent® peripheral spot stent system compared to the Everflex® self-expanding peripheral stent system. The study focuses on treating residual lesions such as stenoses and dissections that remain after balloon angioplasty in the femoral and proximal popliteal arteries. These conditions are common in patients with peripheral arterial disease and affect blood flow in the legs. Participants will receive either the Sperstent® peripheral spot stent system or the Everflex® self-expanding peripheral stent system during endovascular treatment following percutaneous transluminal angioplasty (PTA). Both treatments involve placing a stent to open narrowed or blocked arteries, guided by digital subtraction angiography (DSA). The trial compares these two devices to understand their impact on artery patency and safety over time. Throughout the study, participants will be closely monitored with follow-up assessments including imaging to check artery openness, clinical evaluations of symptoms using Rutherford classification and ankle-brachial index (ABI), and tracking of major adverse events. Key outcomes include primary patency at 12 months and freedom from major adverse events at 30 days after the procedure. The study period includes evaluations immediately after treatment and at 30 days, 6 months, and 12 months to monitor device success, procedural success, and changes in clinical status.

Researchers are evaluating the safety and performance of the Acotec Litos & Tulip Drug-coated Balloon (DEB) catheters for treating lesions in below-the-knee arteries in people with Peripheral Artery Disease. This prospective, multi-center, single arm study aims to gather detailed data on how well this device works and its safety when used for this condition. Participants are adults aged 18 to 75 with specific artery blockage conditions affecting blood flow below the knee. Participants will receive treatment using the DEB catheter, either the AcoArt Tulip (0.018") or AcoArt Litos (0.014") model, to address stenosis or occlusions in below popliteal arteries. This single arm study means all participants receive the study device without comparison groups. The treatment targets significant artery narrowing or blockages to improve blood flow. The study does not mention placebo or alternative treatments. During the study, participants will be monitored through regular follow-up visits to evaluate the primary outcome of artery patency at 6 months. Secondary outcomes include major adverse event rate at 30 days, patency rates up to 60 months, rates of major limb amputation, mortality, vessel and lesion revascularization, ulcer healing, and distal embolization rates. Participants will undergo examinations and assessments specified by the protocol to track their response to the treatment and safety over time. The study is expected to continue until April 2027.

Researchers are evaluating the safety and effectiveness of the AcoArt drug-coated percutaneous transluminal angioplasty (PTA) balloon catheters in patients with symptomatic peripheral artery disease undergoing lower limb revascularization. This observational study includes patients with varying severity of arterial disease, classified by Rutherford Clinical Categories 2-6, to monitor real-world outcomes following standard treatment practices. Participants will receive treatment using one of three types of AcoArt drug-coated PTA balloon catheters—Orchid, Tulip, or Litos—designed for arteries in the lower limbs. The study is a single-arm, multi-center follow-up that observes outcomes without altering usual care, focusing on two patient groups: those with moderate symptoms (Rutherford 2-3) and those with critical limb ischemia (Rutherford 4-6). Throughout the study, participants will undergo various assessments to track safety and treatment effectiveness at multiple time points, including 30 days, 6 months, 12 months, and up to 60 months. Researchers will collect data on clinical improvements, wound healing, need for additional procedures, survival rates, and amputation rates. Patients are expected to attend follow-up visits and comply with study protocols for monitoring and data collection during this extended observation period.

Researchers are evaluating the effect of adding hyperbaric oxygen therapy after lower extremity amputation. The study focuses on patients who have had amputations due to chronic wounds, osteomyelitis, ischemia, or necrosis, conditions commonly associated with poor healing. Hyperbaric oxygen therapy has been used for decades to help heal difficult wounds by increasing oxygen levels in tissues, potentially improving healing at the amputation site and reducing the need for further amputations. Participants who have undergone lower extremity amputation will be randomly assigned to one of two groups. One group will receive 30 sessions of hyperbaric oxygen therapy, each lasting 90 minutes at 2.4 atmosphere absolute (ATA) with 100% oxygen. The first treatment must begin within seven days after amputation, and the therapy is provided as outpatient care after hospital discharge. The other group will receive standard care and outpatient follow-up without hyperbaric oxygen therapy. During the study, participants will be monitored for skin healing at the amputation site up to 12 months, including assessments at 12 weeks, 6 months, 9 months, and 1 year. Researchers will measure outcomes like intact skin without abnormal openings, time to wound closure, reamputations, wound revisions, hospital days, pain levels, quality of life, mobility, and foot and ankle function. Follow-up visits and evaluations will occur regularly to track healing progress and overall health after treatment.

This research aims to assess the long-term safety and performance of two types of vascular grafts, Advanta VXT and Flixene, used for repairing or replacing peripheral arteries. The study focuses on patients who have undergone these surgical procedures and seeks to provide more information about how useful these grafts are in clinical practice. Participants in this registry have received either the Advanta VXT graft, which has two layers including a support layer and sometimes a ringed design, or the Flixene graft, which has three layers and does not require ring support. The study involves collecting data from the time of the surgery and continuing for at least three years afterward to monitor outcomes. During the study, researchers will review medical records and follow-up information for a minimum of three years after the procedure. They will measure the percentage of participants meeting safety and efficacy goals, monitor complications, and assess graft performance using clinical indicators such as the Rutherford Category and Ankle-Brachial Index. This long-term follow-up helps to understand how well these vascular grafts work and their safety in real-world use.