Comparing stent treatments for chronic mesenteric ischemia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.