Ashland

Researchers are evaluating the outcomes of two treatments for lumbar spinal stenosis with neurogenic claudication (LSS with NC) in Medicare beneficiaries. This observational study compares the rates of surgical and minimally invasive interventions, as well as any harms, occurring within 24 months after receiving either the MILD procedure or Interspinous Process Decompression (IPD). The study uses Medicare claims data starting from patients treated on or after January 1, 2017, and continues enrollment until the sponsor stops it. The study groups include Medicare patients who underwent the MILD procedure, which involves a partial decompression performed under fluoroscopic image guidance through the removal of tissue and bone at the symptomatic spinal level. The control group consists of Medicare patients treated with Interspinous Process Decompression during the same enrollment period. Both groups are monitored for reoperation and harms for 24 months following their initial treatment. Participants are included based on Medicare claims with the study's NCT number, which automatically enrolls them without requiring prior consent. Researchers will analyze Medicare claims data to track surgical or minimally invasive interventions and any complications related to the initial procedure over two years. The study does not involve direct patient visits or interventions and is exempt from Institutional Review Board oversight. The total follow-up duration for outcome measurement is 24 months after the index procedure.

Researchers are studying a device called the GORE VIABAHN VBX Balloon Expandable Endoprosthesis to treat people with complex iliac occlusive disease, a condition affecting blood flow in the iliac arteries. This clinical trial is designed to compare this device to bare metal stenting, aiming to see which approach better keeps the arteries open over time. The study is prospective, multicenter, randomized, and controlled with a double masking design. Participants will be randomly assigned to one of two groups: one receiving the GORE VIABAHN VBX device and the other receiving a commercially available bare metal stent approved for this condition. Treatments focus on the common and/or external iliac arteries with lesions between 4 and 11 cm and vessel diameters between 5 mm and 13 mm. Both groups will receive stenting procedures using these devices. During the trial, participants will undergo evaluations to measure artery openness (primary patency) at one year and up to five years. Additional measures include technical and clinical success of procedures, hemodynamic status, quality of life changes, freedom from restenosis and revascularization, amputation-free survival, and overall survival. The study involves follow-up visits over several years to monitor these outcomes and safety.