Gray

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.

This research aims to evaluate the safety and effectiveness of the FastWire System in patients with chronic total occlusions CTOs in the peripheral arteries causing ischemic limbs. It is a single-arm, multi-center, pivotal study involving up to 65 participants who meet specific inclusion and exclusion criteria. The study focuses on assessing whether the FastWire System can assist in placing guidewires or treatment devices beyond these arterial blockages. Participants will undergo a procedure using the FastWire System device to cross CTO caps and multiple lesions in their peripheral arteries. The study does not involve comparison groups and monitors clinical and technical success on the day of the procedure, along with safety events up to 30 days afterward. The device is used intra-luminally during the procedure to facilitate revascularization of lower limbs. During the study, participants will be closely monitored for clinical success and freedom from serious adverse events on the procedure day and up to 30 days post-procedure. Researchers will evaluate technical and procedural success, vessel dissection or bleeding within 24 to 36 hours, and any procedure-related mortality up to 30 days. The total study involvement lasts through the initial procedure and a 30-day follow-up period to assess safety and efficacy outcomes.

Researchers are comparing the rates of surgical and minimally invasive interventions, as well as any harms, in Medicare beneficiaries treated with the MILD procedure versus those treated with interspinous process decompression IPD for lumbar spinal stenosis with neurogenic claudication. This observational study uses Medicare claims data to follow patients for 24 months after their initial procedure starting from January 1, 2017. The purpose is to evaluate outcomes between these two types of procedures without requiring prior patient enrollment or consent. The study includes two groups patients who received MILD, which is a percutaneous image-guided lumbar decompression performed under fluoroscopic guidance through a dorsal approach to the spine, and patients who received IPD, a different device-based decompression procedure. Data on reoperations and complications will be collected for both groups over a 24-month follow-up period using Medicare claims. Enrollment continues until the sponsor decides to stop. Participants involvement is passive as the study uses existing Medicare claims data. Researchers will monitor rates of harms related to the initial procedure and subsequent surgical or minimally invasive interventions over two years. No direct patient visits or interventions are conducted, and the study is exempt from institutional review board oversight. The total study duration extends to December 2026, covering cases treated since early 2017.

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.