Comparing stent treatments for chronic mesenteric ischemia
Copenhagen Mesenteric Stent Study - A Randomized Trial of Stent Versus Covered Stent Treatment for Chronic Mesenteric Ischemia
This study is testing whether covered stents work better than bare metal stents for people with chronic mesenteric ischemia to see which one helps them more after a year.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 98 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rigshospitalet, Denmark Academic / other |
| Locations | 1 site (København Ø) |
| Trial ID | NCT05244629 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the effectiveness of bare metal stents (BMS) versus covered stents (CS) in treating chronic mesenteric ischemia (CMI), a condition caused by narrowed arteries supplying blood to the intestines. Patients with significant stenosis of the superior mesenteric artery will be randomly assigned to receive either type of stent. The primary outcome measured will be stent patency one year after placement, along with assessments of complications, reoperation rates, quality of life, and mortality reasons. The study aims to provide clearer evidence on the benefits of using covered stents over bare stents.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with symptomatic chronic mesenteric ischemia due to significant atherosclerotic stenosis.
Not a fit: Patients with non-atherosclerotic causes of mesenteric ischemia or those experiencing acute mesenteric ischemia will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for patients with chronic mesenteric ischemia, potentially reducing symptoms and recurrence rates.
How similar studies have performed: While the use of covered stents is increasingly supported, the level of evidence is limited, indicating that this approach is still being evaluated.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
København Ø
- Department of Vascular Surgery, Heart Center, Copenhagen University Hospital - Rigshospitalet — København Ø, Denmark (Recruiting)
Study contacts
- Principal investigator: Timothy A Resch, MD, PhD — Deptarment of Vascular Surgery, Rigshospitalet
- Study coordinator: Timothy A Resch, MD, PhD
- Email: timothy.andrew.resch@regionh.dk
- Phone: +45 35 45 79 31
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.