Actively Recruiting
Multicenter Registry Evaluating ALTO Endograft Device for Elective Abdominal Aortic Aneurysm Repair
Led by Gianmarco de Donato · Updated on 2023-07-20
300
Participants Needed
2
Research Sites
52 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the outcomes of treating patients with elective Abdominal Aortic Aneurysm AAA using the ALTO stent graft device from Endologix Inc. This observational study focuses on assessing the results during and after the surgery, including early and late outcomes, in a multicenter experience. The study builds on decades of technological advancements in endovascular aneurysm repair, particularly highlighting the innovative sealing mechanism of the ALTO device. The ALTO device implantation involves placing an aorto-bisiliac endograft to exclude the aneurysm, using a low-profile platform designed for challenging anatomies. All eligible patients undergoing elective endovascular aneurysm repair EVAR with the ALTO device will be included based on their medical needs, anatomical suitability, and physician expertise. The study will collect data during the procedure and at set follow-up times to evaluate technical and clinical success. Participants will be monitored through follow-up visits lasting up to five years, during which researchers will assess technical and clinical success at 90 days, one year, and five years after treatment. Additional measures include operative time, radiation exposure, contrast medium usage immediately after the procedure, and aneurysm shrinkage at one and five years. Patients are expected to comply with follow-up evaluations to help researchers understand the devices performance and patient outcomes over time.
CONDITIONS
Brief Title
ALTo endogrAft Italian Registry
Research Team
G
Gianmarco de Donato, MD, PhD
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