Clinical Trial

Standardization of Physician-Modified Stent Grafts for Abdominal Aortic Aneurysms

Study acronym: RESTORE
Enrolling by Invitation
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Record status
This record was last updated September 19, 2024 (before its estimated June 30, 2025 completion). Its status may not reflect the trial's current state.
Summary
This study explores the use of physician-modified stent grafts (PMSGs) for treating abdominal aortic aneurysms that are unsuitable for open surgery or standard endovascular grafts. Custom-made fenestrated endografts are not viable in urgent or symptomatic cases due to lengthy manufacturing times. Although off-the-shelf branched devices are more readily available, they present challenges such as high costs, extensive thoracic coverage, limited long-term data, and anatomical restrictions. Parallel graft techniques are also associated with concerns regarding their durability. PMSG procedures, however, are not standardized and rely heavily on the physician's experience and expertise. The aim of this comprehensive study is to establish expert consensus on the indications, planning protocols, and procedural techniques for PMSGs.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-09-03.
Trial Details
NCT Number NCT06585215
Lead Sponsor Ente Ospedaliero Cantonale, Bellinzona
Conditions Abdominal Aortic Aneurysm, Endovascular Procedures, Stents, Vascular Surgical Procedures
Enrollment 100 participants
Start Date 2014-06-14
Primary Completion 2025-06-30 (estimated)
Study Completion 2025-06-30 (estimated)
Updated on ClinicalTrials.gov 2024-09-19