Copenhagen Mesenteric Stent Study - A Randomized Trial of Stent Versus Covered Stent Treatment for Chronic Mesenteric Ischemia
Launched by RIGSHOSPITALET, DENMARK · Feb 8, 2022
Trial Information
Current as of November 14, 2025
Recruiting
Keywords
ClinConnect Summary
The Copenhagen Mesenteric Stent Study is a clinical trial designed to compare two types of stents—bare metal stents (BMS) and covered stents (CS)—for treating chronic mesenteric ischemia (CMI), a condition where narrowed arteries reduce blood flow to the intestines, causing symptoms like pain, weight loss, and diarrhea. This study aims to see which type of stent works better over one year in keeping the arteries open and preventing complications. Patients who are eligible for this trial are adults over 18 with significant narrowing of the superior mesenteric artery due to atherosclerosis, meaning they have plaque buildup in their arteries.
Participants in the trial will be randomly assigned to receive either a BMS or a CS, both of which have similar metal structures but differ in their covering. The researchers will also look at how often stents need to be replaced, any complications that may arise, and how the treatment affects patients' quality of life. While the risk of serious complications is low (less than 5%), participants should be aware of potential side effects such as minor bleeding at the procedure site or allergic reactions. This study not only aims to improve treatment options for CMI but also collects blood samples to help understand the disease better.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Patients with symptomatic CMI of atherosclerotic or atherothrombotic etiology
- • Intended endovascular treatment
- • Symptoms consistent with CMI (pain, weight loss, diarrhea)
- • Significant ostial stenosis (\>50%) of the superior mesenteric artery on CTA
- • Significant stenosis on angiography (\>50% or \>15mmHg pressure gradient)
- • Patients \> 18 years
- Exclusion Criteria:
- • No informed consent
- • Non atherosclerotic cause of MI
- • Acute mesenteric ischemia (AMI)
- • Signs of acute bowel ischemia, peritonitis, laparotomy, sepsis
- • Previous stent treatment in the superior mesenteric artery(ies)
- • Target artery lesions \>4cm in length
- • Unable to cross lesion with guidewire
- • Non-significant stenosis angiographically
- • Pregnancy
- • Allergies to contrast media or stent materials
About Rigshospitalet, Denmark
Rigshospitalet, located in Copenhagen, Denmark, is one of the leading hospitals in Scandinavia and a prominent center for clinical research and innovation. As a key academic institution affiliated with the University of Copenhagen, Rigshospitalet is dedicated to advancing healthcare through rigorous clinical trials and groundbreaking research across various medical disciplines. The hospital’s commitment to excellence is reflected in its multidisciplinary approach, collaboration with international research networks, and focus on improving patient outcomes through evidence-based practices. With state-of-the-art facilities and a team of highly qualified professionals, Rigshospitalet plays a crucial role in translating scientific discoveries into effective treatments and therapies.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
København ø, Denmark
Patients applied
Trial Officials
Timothy A Resch, MD, PhD
Principal Investigator
Deptarment of Vascular Surgery, Rigshospitalet
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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