Arteriovenous Fistula

Researchers are evaluating a new 10-minute cardiovascular magnetic resonance CMR imaging protocol designed to improve current CMR procedures for patients with various heart conditions, including coronary artery disease, cardiomyopathies, and other cardiac diseases. The study aims to develop a standardized, contrast-free imaging method that can be applied to about 70% of cardiac patients. The goal is to assess whether this shorter protocol enhances diagnostic decision-making and reduces healthcare costs. The study involves two groups healthy volunteers over 18 years old without significant cardiovascular or respiratory conditions, and patients over 18 years who require a clinically indicated CMR exam. The new protocol focuses on heart function and tissue characterization without using contrast agents. Researchers will compare the new 10-minute protocol to standard CMR imaging, evaluating its clinical feasibility, performance, and cost-effectiveness in different patient populations. Participants will undergo CMR scans using both the new and standard protocols. Researchers will monitor diagnostic results, scan completion rates, scan sequence times, adverse events, and cost differences between methods. Various heart tissue measurements and reproducibility between different readers and scanners will also be assessed. The study spans from 2019 to 2025, with ongoing safety monitoring during imaging sequences and a focus on improving the efficiency and quality of cardiac imaging.

Researchers are evaluating the safety and effectiveness of RLY-2608, a mutant-selective oral PI3K inhibitor, in adults and children with PIK3CA Related Overgrowth Spectrum PROS and malformations driven by PIK3CA mutation. This Phase 2 study has three parts Part 1 focuses on dose selection, Part 2 includes exploratory single-arm cohorts for different participant groups, and Part 3 is a randomized, double-blinded study comparing RLY-2608 to a placebo. Participants receive RLY-2608 orally in various doses depending on their age group and study part. Children aged 2 to under 6 years and 6 to under 12 years undergo dose escalation to find the recommended dose, while older participants receive established doses. Part 3 involves randomization to either RLY-2608 or placebo for participants aged 6 years and older. Each part includes dosing cycles and treatment schedules designed to assess safety and efficacy. During the study, participants undergo assessments including lesion volume measurements, blood tests, ECGs, and biopsies to confirm PIK3CA mutation status. Researchers monitor adverse events and treatment effects through regular visits and imaging at baseline, Week 12, and Week 24. Patient-reported outcomes and quality of life measures are also collected monthly in Part 3. The study spans several years, with ongoing safety and efficacy evaluations throughout treatment and follow-up periods.

Researchers are evaluating non-invasive imaging methods to assess skin blood flow dynamics. This study aims to test and validate how well these imaging technologies perform by using a pressure cuff to create changes in blood flow, ranging from low flow ischemic to high flow hyperemic. The focus is on establishing the basic feasibility of these imaging tools in detecting vascular changes. The study uses Multi-Spectral Imaging and Laser Speckle Imaging, both non-contact optical devices. Multi-Spectral Imaging measures concentrations of total, deoxygenated, and oxygenated hemoglobin in tissue, while Laser Speckle Imaging measures relative blood flow at different times. A pressure cuff occlusion is applied to stimulate changes in blood flow for these devices to detect. Participants will be observed using these imaging methods during vascular occlusion procedures. The main outcome measured is skin blood flow over a 4-week period. The study includes healthy volunteers aged 18 and older and involves non-invasive tests without treatment. Researchers will monitor blood flow changes and the performance of the imaging devices during the study period, which began in 2011 and is expected to continue until 2028.

Researchers are investigating targeted drug therapies for patients with vascular malformations that are resistant to standard treatments or for whom standard treatments are unsuitable. These vascular malformations are classified as either slow-flow or fast-flow types, driven by genetic changes in two specific signalling pathways. This phase II open-label trial aims to evaluate the effects of 48 weeks of treatment using either alpelisib for slow-flow vascular malformations with PI3K pathway mutations or mirdametinib for fast-flow vascular malformations with MAPK pathway mutations. Participants are divided into two treatment groups based on their vascular malformation type and genetic mutation. Those with slow-flow malformations and PI3K pathway mutations will receive alpelisib, an oral PI3-kinase inhibitor, for 48 weeks followed by a 24-week follow-up. Those with fast-flow malformations and MAPK pathway mutations will receive mirdametinib, an investigational oral MEK inhibitor, also for 48 weeks followed by 24 weeks of follow-up. Both treatments are given as monotherapy and involve genetic testing before enrollment to confirm mutations. Throughout the study, participants will undergo various assessments including symptom evaluations using the Vascular Malformation Patient Specific Outcome Measure VM-PSOM and OVAMA questionnaires, MRI scans to measure lesion size, and monitoring for adverse events. The primary outcome is the improvement in the most significant symptom after 48 weeks of treatment. Follow-up visits continue for 24 weeks after treatment ends to monitor ongoing effects and safety. The total participation duration for each patient is approximately 72 weeks.

This research focuses on patients with end-stage renal disease ESRD, a condition affecting many people worldwide, especially as populations age and patients live longer on renal replacement therapy. Most patients with ESRD undergo hemodialysis HD, which requires a reliable vascular access VA such as an arteriovenous fistula AVF or an arteriovenous graft AVG. The study aims to evaluate the use of vascular access sound recordings and analysis to monitor VA function and predict complications like stenosis or failure, helping to improve patient outcomes. The study involves two groups of ESRD patients needing VA surgery for hemodialysis one group receiving AVF creation, where a vein and artery are surgically connected in the forearm, and another receiving AVG creation, which uses an artificial plastic tube to connect an artery to a vein. This is a prospective observational study where VA sounds and Doppler ultrasound examinations will be collected over time to assess vascular remodeling and access function. Participants will have their vascular access sounds recorded and undergo ultrasound exams from day 7 after surgery up to 24 months. Researchers will monitor changes in sound characteristics and blood flow volume to evaluate VA maturation and function. The primary outcome measure is the low-high peak ratio LHPR of the sound, tracked over the study period. This approach aims to provide a non-invasive method to predict VA complications and improve management in ESRD patients on hemodialysis.

Researchers are evaluating the safety and effectiveness of everolimus monotherapy in adults with vascular malformations. This single-arm exploratory trial is conducted by Xuanwu Hospital, Capital Medical University, and includes adult patients aged 18 to 65 who have vascular malformations confirmed by MRI and are unsuitable for effective surgical treatment. Participants will take oral everolimus 10 mg daily in continuous 28-day treatment cycles. Treatment will continue until disease progression, intolerable side effects, lack of benefit as judged by the investigator, study end, or other criteria for stopping treatment. The study includes assessments at multiple points, including after 3, 6, and 12 treatment cycles, and every 6 cycles thereafter. During the study, participants will undergo MRI scans to measure lesion volume and assess microbleeding, iron deposits, and hemorrhage risk. Clinical signs, symptom scores, and quality of life will also be evaluated. These evaluations are scheduled during screening, after certain treatment cycles, and at the end of treatment. The main outcome measured is the response rate based on MRI after one year of treatment.

This research aims to collect and assess clinical data on patients using the Lifetech Cera Vascular Plug System, a device designed for arterial and venous embolization in the peripheral vasculature. The studys purpose is to confirm the safety and performance of this device, identify any previously unknown side effects, monitor known side effects related to the device or procedures, and analyze emerging risks associated with its use. Participants will receive treatment with the Cera Vascular Plug System, which includes a self-expandable cylindrical Ni-Ti wire mesh plug and an accessory introducer kit. The study is observational and single-arm, enrolling patients who require arterial or venous embolization in the peripheral blood vessels. Each participant will be followed for approximately one year after the procedure to monitor outcomes and any device-related events. During the study, participants will undergo evaluations to measure technical success at the time of the procedure and follow-up assessments at 3, 6, and 12 months to detect clinically relevant recanalization and migration. Researchers will also monitor adverse events, serious adverse events, and device deficiencies throughout the year. The study includes various clinical visits and assessments to ensure thorough safety and performance monitoring over the total participation period of one year.

Researchers are conducting the Comprehensive HHT Outcomes Registry of the United States CHORUS, an observational study focusing on Hereditary Hemorrhagic Telangiectasia HHT, a rare genetic condition causing abnormal blood vessels in various organs. The study aims to better understand HHT, its symptoms, complications, and how it affects peoples lives. By collecting detailed information over time, the study hopes to improve knowledge of the disease and assist in developing new treatments. Participants diagnosed with HHT based on specific criteria or genetic testing will be included in the registry. The study will collect long-term data both retrospectively and prospectively from about 10,000 patients across multiple centers in the U.S. Over up to 10 years, participants will provide information through medical records and yearly questionnaires, helping researchers track changes in health, treatments, and symptoms. During participation, individuals will allow access to their medical records and answer study questions at enrollment and annually for up to 10 years or until the study ends. The data collected includes demographic details, diagnosis, family history, test results, symptoms, and treatments. The main outcomes measured over 10 years include baseline health status and clinical outcomes using specific assessment scales. The study also monitors severity of nosebleeds, development of vascular malformations, treatment results, and serious health events related to HHT.

Researchers are evaluating the effectiveness and safety of two types of balloon treatmentscutting balloons and drug-coated balloonsfor venous stenosis in autologous arteriovenous fistulas used for hemodialysis. The study aims to determine whether drug-coated balloons offer better outcomes in terms of reducing the need for repeat procedures and to understand medical issues that may occur during treatment. The study will include 180 patients divided into two groups based on the treatment they receive one group treated with cutting balloons and the other with drug-coated balloons. The treatments involve endovascular therapy, a minimally invasive procedure using catheters to access and treat the narrowed vein segments. The primary focus will be on patency rates and re-intervention rates at 1, 3, 6, and 12 months after the procedure, along with technical and procedural success and monitoring for major adverse events. Participants will be followed closely with evaluations at multiple time points to assess the condition of the treated arteries and veins. Researchers will track outcomes like the number of participants needing another procedure and how well the treated blood vessels remain open. The study will also monitor any complications during the perioperative period. The entire study will take place between June 2024 and December 2025, with follow-up assessments up to 12 months after treatment.

End-stage renal disease ESRD is a serious global health issue where patients often need hemodialysis using an arteriovenous fistula AVF for vascular access. AVFs are preferred due to longer use, fewer infections, and lower death rates compared to other options. However, many AVFs fail early because they do not mature properly, which happens in 20-40% of cases, making them unusable for dialysis. This research evaluates whether short-term use of apixaban, a blood thinner given during the critical 6-week maturation period after AVF creation, can improve fistula maturation rates without causing significant bleeding problems. The study compares two groups of adult ESRD patients undergoing primary upper arm AVF creation. One group receives apixaban 2.5 mg twice daily for 6 weeks starting after surgery, while the other group receives a matching placebo. Both groups receive standard intraoperative heparin during surgery but no study drug until 24 hours after surgery. Patients are followed for 6 months, with key assessments at 6 weeks, 3 months, and 6 months, including ultrasound measurements of vein size and blood flow, clinical exams, and recording dialysis use. Participants will undergo screening, surgery, and regular follow-up visits for clinical exams, ultrasound scans, lab tests, and monitoring for side effects like bleeding or hematoma. Researchers will measure fistula maturation based on size, blood flow, and usability for dialysis at 6 weeks, along with longer-term patency and complications. Compliance with study drug is checked by pill counts. Safety is overseen by a monitoring board, and data will be analyzed to see if apixaban improves AVF success compared to placebo.