Copenhagen Mesenteric stent study (COMESS)-a randomized trial of stent versus covered stent treatment for chronic mesenteric ischemia

• Published in: Current controlled trials in cardiovascular medicine 2024-06, Vol.25 (1), p.426-10, Article 426
• Main Authors: Brandtzäg, Alexandra A, Eiberg, Jonas P, Lönn, Lars, Taudorf, Mikkel, Resch, Timothy A
• Format: Article
• Language: English
• Subjects: Angioplasty; Atherosclerosis; Chronic Disease; Denmark; Diarrhea; Endovascular Procedures - adverse effects; Endovascular Procedures - instrumentation; Endovascular Procedures - methods; Endovascular treatment; Humans; Informed consent; Ischemia; Medical referrals; Mesenteric ischemia; Mesenteric Ischemia - surgery; Mesenteric Ischemia - therapy; Nutrition; Parenteral nutrition; Patients; Prospective Studies; Prosthesis Design; Randomized controlled trial; Randomized Controlled Trials as Topic; Sepsis; Single-Blind Method; Stent; Stents; Treatment Outcome; Vascular surgery
• ISSN: 1745-6215; 1745-6215
• DOI: 10.1186/s13063-024-08285-5

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. This is an investigator-driven, prospective, randomized, single-blinded, and single-center, national cohort study at the Copenhagen University Hospital, Denmark. A total of 98 patients with chronic mesenteric ischemia (CMI) and acute-on-chronic mesenteric ischemia (AoCMI) will be randomized to treatment with either BeSmooth BMS (Bentley Innomed GmbH) or BeGraft CS (Bentley Innomed GmbH). Randomization occurs intraoperatively after lesion crossing. 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. ClinicalTrials.gov NCT05244629. Registered on February 8, 2022.