Status:
RECRUITING
Copenhagen Mesenteric Stent Study - A Randomized Trial of Stent Versus Covered Stent Treatment for Chronic Mesenteric Ischemia
Lead Sponsor:
Rigshospitalet, Denmark
Collaborating Sponsors:
University of Copenhagen
Conditions:
Mesenteric Ischemia
Bowel; Ischemic
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Chronic mesenteric ischemia (CMI) is often caused by narrowings in the arteries providing blood to the intestines. Endovascular stent placement is considered the preferred treatment for this condition...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2029
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT05244629
Start Date
June 1 2023
End Date
August 1 2029
Last Update
June 12 2023
Active Locations (1)
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1
Department of Vascular Surgery, Heart Center, Copenhagen University Hospital - Rigshospitalet
København Ø, Denmark, 2100