Abstract
Background
Current management of mesenteric ischemia is primarily endovascular stent treatment. Typical CMI symptoms are postprandial abdominal pain, food fear, weight loss, and diarrhea. Revascularization is often necessary, as mesenteric ischemia may progress to bowel necrosis and death if left untreated. This study aims to compare the outcome using bare metal stent (BMS) or covered stent (CS) in the endovascular treatment of chronic and acute on chronic mesenteric ischemia.
Methods
This is an investigator-driven, prospective, randomized, single-blinded, and single-center, national cohort study. Patients with chronic mesenteric ischemia (CMI) and acute-on-chronic mesenteric ischemia (AoCMI), are randomized to treatment with either BeSmooth BMS (Bentley Innomed GmBh) or BeGraft CS (Bentley Innomed GmBH). Randomization occurs intraoperatively after lesion crossing.
Discussion
There is currently no published data from prospective controlled trials regarding the preferred type of stent used for the treatment of chronic and acute-on-chronic mesenteric ischemia. This trial will evaluate the short- and long-term outcome of BMS versus CS when treating CMI and AoCMI, as well as the benefit of a more intense postoperative surveillance program.
Trial Registration:
Clinicaltrial.gov NCT05244629 Registered: 2022-02-08