Darien

This observational clinical study is designed to collect data in the United States to support the re-launch and regulatory approval of the redesigned Beacon Tip Sizing Catheter and Slip-Catheter Beacon Tip Catheter Shuttle Select Slip-Catheter. The study focuses on evaluating these devices used in angiographic procedures for conditions such as stenosis, intracranial bleeding, stroke, TIA, vascular malformation, and pseudoaneurysm. The purpose is to assess safety and performance according to their intended use. Participants will undergo procedures using the Beacon Tip Catheters, which are designed for use by physicians trained in angiographic techniques. These catheters include marker bands for anatomical measurements and are used with standard vascular access methods. The study monitors use through the end of the index procedure and up to 30 days post-procedure to collect relevant safety and performance data. During the study, researchers will track successful navigation of the catheter to the intended location and whether the catheter performs as intended during the approximately one-hour procedure. They will also monitor for any major catheter-related complications up to 30 days after the procedure. Participant involvement primarily includes the procedure itself and follow-up monitoring to assess outcomes and safety over this time frame.

Researchers are evaluating the use of Orion17, a dual-layer amniotic membrane allograft, in addition to standard wound care for people over 50 years old with diabetic foot ulcers. The study aims to compare the healing outcomes between those receiving standard wound care alone and those receiving standard care plus the amniotic membrane allograft. The main goal is to determine the rate of complete wound closure after 12 weeks of treatment. Participants will be randomly assigned to one of two groups one receiving standard wound care, which includes surgical cleaning, infection screening, weekly collagen alginate dressings, and off-loading devices and another receiving the same standard care plus weekly applications of the Orion17 amniotic membrane allograft. The treatment period lasts 12 weeks, during which wound healing progress is closely monitored. Throughout the study, participants will visit their doctor weekly for wound assessments and to complete quality of life questionnaires. Researchers will measure outcomes such as incidence and time to complete wound closure, changes in wound size, quality of life improvements, and record any adverse events. Follow-up monitoring continues for six months after treatment to track wound recurrence and other health events, ensuring comprehensive evaluation of the treatments over time.

Researchers are conducting a prospective online registry to explore the potential benefits and safety of external trigeminal nerve stimulation eTNS for treating migraines in pregnant women. The registry includes women with migraines or headaches who are pregnant, whether or not they use the eTNS device. The main goal is to determine if eTNS is a safe and effective option for migraine treatment during and after pregnancy. Participants are divided into two groups those who use the eTNS device during pregnancy and those who do not. Use of the device is not required to join the registry, and participants may start or stop using eTNS at any time without affecting their participation. The registry collects information entirely online through surveys completed at specific pregnancy and postpartum time points, including pre-pregnancy, each trimester, and early and late postpartum periods. Women enrolled will complete up to six surveys over about 12 months, covering health history, migraine symptoms, treatments, and mental health impacts. Participants using eTNS will answer additional questions about device use. Surveys are sent via email and text, with identity verification to protect data. The registry measures outcomes like the rate of miscarriage and postpartum bonding, with overall participation time estimated between 60 and 90 minutes.

Researchers are evaluating a medical procedure that uses a commercially available catheter called the Bullfrog Micro-Infusion Device to deliver an anti-inflammatory drug, dexamethasone sodium phosphate injection, locally around deep veins after removing blood clots DVT recanalization. This study focuses on patients who had deep vein thrombosis symptoms for up to 14 days before the initial clot removal. The goal is to determine if reducing local inflammation can help prevent new clots from forming and improve symptoms for up to 24 months after treatment. Participants receive either the anti-inflammatory drug dexamethasone delivered around the target vein segment or a saline solution as a comparison, both using the same device. This is a randomized, quadruple-masked trial where neither the participants, care providers, investigators, nor outcomes assessors know which treatment is given. The study includes treatment of acute femoropopliteal DVT located in major veins of the leg, with successful clot removal prior to treatment. The study treatment is combined with prescribed anticoagulant and antiplatelet medications for up to 12 months post-procedure. During the study, participants will complete questionnaires and attend follow-up visits to monitor their condition and treatment effects. Researchers will assess outcomes including the rate of keeping the vein open primary patency at 6 months, prevention of post-thrombotic syndrome progression at 6 months, and freedom from major adverse events at 30 days. Participants will be followed for up to 24 months to evaluate long-term benefits and safety of the treatment.

Researchers are evaluating a medical procedure using the Bullfrog4 Micro-Infusion Device to deliver the anti-inflammatory drug dexamethasone sodium phosphate injection around deep veins after recanalization treatment for iliofemoral deep vein thrombosis DVT. This study focuses on participants who experienced DVT symptoms between 14 and 60 days before the recanalization. The goal is to determine if local anti-inflammatory treatment helps prevent re-thrombosis and improves symptoms for up to 24 months following the procedure. Participants are randomly assigned to receive either the dexamethasone treatment or a saline placebo delivered around the target vein segment with the infusion device. This is a phase 2, quadruple-masked study comparing the effects of perivascular dexamethasone versus a sham procedure following successful DVT recanalization and stenting of the iliofemoral segment. Treatment is given during the recanalization procedure, and participants follow a prescribed anticoagulant and antiplatelet medication regimen. During the study, participants undergo clinical assessments to measure primary vein patency at 6 months and monitor for major adverse events within 30 days after treatment. Follow-up visits and questionnaires continue for up to 24 months to evaluate symptom improvement and vessel health. Researchers will also monitor adherence to medication and overall safety throughout the study duration.

Researchers are gathering ongoing information on the safety and performance of Medtronic products that are already available on the market. This registry study aims to support patients, hospitals, clinicians, regulators, payers, and the medical industry by simplifying the process of monitoring these products and providing up-to-date performance data. The study involves collecting data on patients who have received or are planned to receive Medtronic medical devices or therapies. Enrollment includes both prospective and retrospective participants within a specific time frame related to their therapy start. There are no specific interventions assigned, as this is an observational registry. Participants provide written consent and are followed periodically, typically every 6 to 12 months depending on the therapy, to assess the safety and effectiveness of their Medtronic product. Researchers collect information from medical records and follow-up visits to monitor outcomes over time. Participants may be followed for many years, with the study currently planned through January 2040.

Researchers are evaluating the safety and effectiveness of the SELUTION SLR14 Drug Eluting Balloon DEB compared to plain uncoated balloon angioplasty in patients with peripheral arterial disease PAD affecting the below-the-knee BTK arteries, specifically in those with chronic limb-threatening ischemia CLTI. The study aims to show that the SELUTION SLR14 DEB has better efficacy and similar safety compared to the uncoated balloon treatment. Participants are adults aged 18 years or older with documented CLTI and significant narrowing in BTK arteries. The trial randomly assigns participants to one of two groups one receiving the SELUTION SLR14 DEB and the other receiving plain balloon angioplasty. Both are non-surgical procedures where a catheter inflates a balloon to open narrowed arteries below the knee. Treatments target specific lesions in BTK arteries and must meet detailed angiographic criteria. The study uses a single-blind design and includes follow-up assessments over several years. Participants will undergo evaluations at multiple time points including 30 days, 6 months, and up to 36 months after treatment. Assessments include clinical improvement, amputation rates, wound healing, imaging, and quality of life measures. Safety endpoints are monitored early, while efficacy outcomes are tracked long term. The study also evaluates device and procedural success immediately after treatment. Overall participation may last over three years to gather comprehensive safety and effectiveness data.

Researchers are evaluating the GORE4 VIABAHN4 FORTEGRA Venous Stent for treating symptomatic iliofemoral venous obstruction. This prospective, non-randomized, multicenter clinical study aims to assess the devices safety, performance, and effectiveness in patients suffering from this vein condition. The study involves multiple sites across the U.S. and is sponsored by W.L.Gore Associates. The study involves implanting the GORE4 VIABAHN4 FORTEGRA Venous Stent into affected veins in up to 165 participants. The stent is designed to treat unilateral symptomatic iliofemoral venous obstruction. After the procedure, participants will have follow-up visits scheduled at 1, 6, 12, 24, 36, 48, and 60 months to monitor the stents performance and safety. Participants will be evaluated through hospital discharge and during the scheduled follow-up visits. Assessments include imaging to confirm stent patency, monitoring for adverse events such as embolization or bleeding, and clinical evaluations using scales like the Revised Venous Clinical Severity Scale rVCSS and quality-of-life questionnaires. The study measures procedural success and monitors safety events up to 12 months, with longer-term follow-up extending to 60 months to assess sustained outcomes and device performance.