Wilsonville

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 superiority of the GORE VIABAHN VBX Balloon Expandable Endoprosthesis compared to bare metal stenting for patients with complex iliac occlusive disease, which is a form of peripheral arterial disease affecting the aortoiliac arteries. This study is a prospective, multicenter, randomized, controlled clinical trial focusing on improving primary patency rates at one year after treatment. Participants will receive treatment by stenting their common and/or external iliac arteries using either the GORE VIABAHN VBX device or a commercially available bare metal stent approved for the disease. The study compares these two devices to assess their effectiveness in managing lesions in these arteries. The specific devices are used to treat lesions that are between 4 and 11 cm in length and have a vessel diameter between approximately 5 mm and 13 mm. During the study, participants will be monitored for the primary outcome of primary patency at one year, which means the artery remains open without significant blockage after treatment. Patients will undergo follow-up visits to assess their condition and the effectiveness of the stents. Researchers will evaluate clinical symptoms, imaging, and other assessments to track treatment success and any complications throughout the study duration.