Gray

Researchers are evaluating the safety and effectiveness of the Auryon Atherectomy System combined with balloon angioplasty compared to balloon angioplasty alone for treating blockages in the lower limbs. The study focuses on patients with peripheral arterial disease, specifically critical limb ischemia affecting infrapopliteal arteries. It aims to determine whether the combination treatment better prevents death, amputation, the need for further procedures, and improves artery openness over 12 months. Participants will receive either the Auryon Atherectomy System, which includes a laser and catheter device, plus standard balloon angioplasty, or balloon angioplasty alone. Eligible patients must have a single treated lesion located in native infrapopliteal arteries with defined severity and vessel size criteria. The study includes a randomized controlled trial and an observational group for those who do not meet all criteria for randomization but are treated with the Auryon system. During the 12-month study, researchers will monitor participants' health outcomes related to limb function and survival. Assessments will include imaging to confirm vessel status, clinical evaluations, and monitoring for adverse events. The main measurement compares outcomes between the two treatment groups in a hierarchical manner over the treatment period. Up to 1500 subjects may be enrolled in the observational portion, providing additional safety and effectiveness data.

Researchers are evaluating the safety and effectiveness of the FastWire System in patients who have chronic total occlusion (CTO) in the arteries of their lower limbs, which causes poor blood flow and ischemic limbs. This pivotal, single-arm, multi-center study plans to enroll up to 65 participants with severe claudication or critical limb-threatening ischemia (CLTI) to assess whether the FastWire System can successfully assist in placing guidewires or treatment devices through blocked peripheral arteries. During the procedure, investigators will use the FastWire System to cross the CTO caps or multiple lesions in the affected arteries below the origin of the superficial femoral artery, either above or below the knee. Participants must have angiographic confirmation of a de novo CTO with a total length less than 40 cm and at least one patent runoff vessel if the CTO is below the knee. The study does not include a comparison group and focuses on the performance of this device in real-world clinical settings. Participants will be closely monitored for clinical success on the day of the procedure and for freedom from serious adverse events up to 30 days afterward. The study involves detailed imaging assessments at the time of the procedure and ongoing safety evaluations. Overall participation will cover the procedure day and follow-up through the first month to assess initial safety and efficacy outcomes related to the FastWire System.

Researchers are evaluating surgical and minimally invasive treatments for lumbar spinal stenosis (LSS) by comparing Medicare patients who received the MILD procedure against those who had interspinous process decompression (IPD). The study focuses on outcomes such as the rate of harms related to the initial procedure and the frequency of additional surgical or minimally invasive interventions within 24 months after treatment. Enrollment includes patients treated from January 1, 2017, onward, with continuation until the sponsor decides to stop. The MILD procedure involves percutaneous image-guided lumbar decompression, performed under fluoroscopy through a dorsal approach to partially remove tissue and bone at the affected spinal level. The control group receives the IPD procedure for LSS. Both groups are monitored for a 24-month period post-index procedure using Medicare claims data to track reoperations and any harms. Participants contribute data through Medicare claims without needing prior enrollment or consent, as the study is exempt from IRB oversight. Researchers collect and analyze information on procedure-related harms and subsequent interventions over two years. This approach allows evaluation of long-term safety and effectiveness outcomes for patients treated with either MILD or IPD.

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.