Copenhagen Mesenteric Stent Study: Randomized Trial Comparing Bare Metal Stent and Covered Stent Treatments for Chronic Mesenteric Ischemia

What this Trial Is About

Researchers are evaluating treatments for chronic mesenteric ischemia (CMI), a condition caused by narrowing of arteries supplying blood to the intestines. This prospective, randomized controlled trial compares two types of stents: bare metal stents (BMS) and covered stents (CS). The study aims to assess outcomes such as stent openness one year after placement, complications, reoperation rates, quality of life, and reasons for death in patients with symptomatic CMI. Participants will be randomly assigned to receive either a BeSmooth bare metal stent or a BeGraft covered stent, both made by Bentley Innomed GmbH. The stents have identical metal structures, differing only in the graft covering. Blood samples will also be collected to study disease markers and their effects on treatment outcomes. The study follows patients for primary outcomes at 12 months and secondary outcomes including survival and quality of life for up to 5 years. During the study, participants will undergo evaluations including imaging to confirm artery narrowing and procedure-related monitoring. Researchers will track stent patency, complications related to the procedures, and quality of life using SF-36 questionnaires. Risks include less than 5% chance of procedure-related complications such as bleeding, thrombosis, impaired kidney function from contrast, and rare serious events. The total participation duration includes follow-up visits for up to five years to monitor long-term outcomes.

Copenhagen Mesenteric Stent Study - A Randomized Trial of Stent Versus Covered Stent Treatment for Chronic Mesenteric Ischemia