Darien

Researchers are evaluating the safety and performance of the re-designed Beacon Tip Sizing Catheter and Slip-Catheter Beacon Tip Catheter in patients undergoing angiographic procedures. This observational post-market clinical study is conducted in the United States to support the re-launch of these catheters for regulatory approval in the European Union and possibly other regions. The study focuses on patients with conditions such as stenosis, intracranial bleeding, stroke, transient ischemic attack (TIA), vascular malformation, and pseudoaneurysm. The study involves the use of Beacon Tip Catheters during angiographic procedures performed by trained physicians. These catheters have marker bands that help with anatomical measurements. Standard techniques for placing vascular access sheaths, angiographic catheters, and wire guides will be used. The evaluation covers the procedure itself and follows patients for up to 30 days afterward to monitor safety and performance. Participants undergo the procedure using the applicable Beacon Tip Catheter, and researchers will collect data on successful navigation to the intended location, successful use of the catheter, and freedom from catheter-related major complications during the procedure and up to 30 days post-procedure. The total duration of the procedure is approximately one hour. Data collection includes monitoring safety and performance as per the catheter's intended use to ensure an acceptable benefit-to-risk balance.

Researchers are studying the potential benefits and safety of external trigeminal nerve stimulation (eTNS) for treating migraine in pregnant women. The study includes women with migraines or headaches who are pregnant, whether or not they use the eTNS device, also known as CEFALY. The main goal is to find out if eTNS is a safe and effective migraine treatment during and after pregnancy, with participation lasting up to 12 months and surveys conducted online. Participants may or may not use eTNS or other migraine treatments, and there are no required treatment changes to join. The study enrolls women ideally within 14 weeks of pregnancy but allows participation at any stage of pregnancy. After confirming pregnancy through uploaded documents, participants will complete up to six online surveys at specific times: baseline, first, second, and third trimesters, and early and late postpartum periods. Each survey takes about 10 to 20 minutes, with total participation time around 60 to 90 minutes. Participants provide information on their health, migraine history, treatment use, and complete validated scales about migraine impact and mental health. If using eTNS, additional questions about device use are included. Researchers monitor responses for clarity and may contact participants if needed. Outcomes measured include miscarriage rates per trimester and postpartum bonding assessed by a maternal-to-infant bonding scale, with data collected over about two years.

Researchers are studying a medical procedure that uses the Bullfrog® Micro-Infusion Device to deliver the anti-inflammatory drug dexamethasone sodium phosphate injection around deep veins after treating deep vein thrombosis (DVT). This study focuses on patients with DVT symptoms lasting up to 14 days before the recanalization procedure. The goal is to find out if reducing local inflammation helps prevent blood vessel re-blockage and improves symptoms for up to 24 months after the initial procedure. Participants will be assigned to receive either perivascular dexamethasone or a saline sham treatment delivered around the affected vein segments. The study involves acute femoropopliteal DVT patients who have undergone successful thrombus removal from the major femoropopliteal veins, possibly extending into the iliac veins. The treatments are given as part of a phase 2 clinical trial evaluating these two approaches. During the study, participants will be monitored for clinically relevant vein openness (primary patency) and prevention of post-thrombotic syndrome (PTS) over 6 months, along with tracking major adverse events within 30 days. Follow-up assessments will include questionnaires and visits over a 24-month period to evaluate symptom improvement and treatment safety.

Researchers are evaluating a medical procedure using a catheter called the Bullfrog Micro-Infusion Device to deliver an anti-inflammatory drug, dexamethasone sodium phosphate, around deep veins after removing blood clots in patients with iliofemoral deep vein thrombosis (DVT). The study focuses on people who have had DVT symptoms for at least 14 days but no more than 60 days before the clot removal. The goal is to determine if local anti-inflammatory treatment helps prevent the reformation of clots and improves symptoms for up to 24 months after the initial procedure. Participants receive either perivascular dexamethasone or a saline solution delivered around the affected vein segment using the catheter. This is a phase 2 study comparing these two treatments after successful recanalization of the target vein and includes patients who require stenting of the iliofemoral segment. The treatment is given locally at the time of vein recanalization. During the study, participants will be monitored for clot openness (primary patency) at 6 months and for any major adverse events within 30 days. They will undergo follow-up visits, complete questionnaires, and have ongoing evaluations to track symptoms and safety for up to 24 months. The study requires adherence to prescribed anticoagulant and antiplatelet medications as part of post-procedure care.

This research aims to continuously evaluate and report on the safety and effectiveness of Medtronic products that are already available on the market. It addresses a wide range of conditions including cardiac rhythm disorders, neurological and cardiovascular disorders, digestive issues, respiratory therapy, and various surgical and diagnostic procedures. The registry supports patients, hospitals, clinicians, regulatory bodies, payers, and industry by simplifying the clinical monitoring process and enhancing performance assessment. Participants in this registry are those who have received or are planned to receive treatment with eligible Medtronic products. Enrollment can occur within a specific time window relative to starting therapy or retrospectively. The study does not involve specific interventions but focuses on the ongoing collection of data related to the products in use. During participation, individuals will be monitored periodically every 6 to 12 months depending on their therapy. Researchers will collect data to assess safety and effectiveness without additional procedures beyond standard care. Follow-up will continue as long as the therapy is ongoing, with the goal of providing long-term surveillance and valuable information to improve patient care and product performance.

Researchers are evaluating the safety and effectiveness of the SELUTION SLR14 drug-eluting balloon compared to a plain (uncoated) balloon angioplasty for treating peripheral arterial disease in below-the-knee arteries of patients with chronic limb-threatening ischemia. The study aims to show better treatment success with the drug-eluting balloon while maintaining similar safety. Eligible patients have significant artery narrowing and symptoms lasting more than two weeks. Participants will receive either the SELUTION SLR14 drug-eluting balloon or the plain balloon during a non-surgical procedure where a catheter inflates the balloon to open narrowed arteries below the knee. The study focuses on lesions in specific below-the-knee arteries and follows strict criteria for lesion size, location, and vessel condition. The treatments are delivered through minimally invasive catheter techniques. During the study, participants will be monitored for safety up to 30 days and for treatment effectiveness over 6 months. Assessments include imaging to confirm artery opening, clinical evaluations, and follow-up visits to track healing and limb function. The study also observes for complications or adverse events to ensure participant safety throughout the trial.

Researchers are evaluating the performance, safety, and effectiveness of the GORE4 VIABAHN4 FORTEGRA Venous Stent for treating symptomatic iliofemoral venous obstruction. This is a prospective, non-randomized, multicenter, single-arm clinical study involving up to 30 clinical sites across the U.S. The study aims to enroll 165 subjects who will receive the stent to help improve blood flow in affected veins. Participants will be treated with the GORE4 VIAFORT Vascular Stent, targeting unilateral symptomatic iliofemoral venous obstruction. The stent is implanted during a procedure designed to open blocked or narrowed veins. The study includes patients with non-malignant venous obstruction meeting specific clinical and anatomical criteria, and the procedure involves use of imaging to guide stent placement. Only one stent type is used, and treated subjects are limited per site. After treatment, participants will be followed closely starting from hospital discharge, with follow-up visits scheduled at 1, 6, 12, 24, 36, 48, and 60 months to monitor safety and device performance. Researchers will assess safety events such as stent embolization and evaluate effectiveness by measuring vein openness (primary patency) over 12 months. Additional monitoring includes clinical assessments and imaging as needed to track outcomes and ensure participant safety throughout the study duration.