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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Objective: To evaluate the outcomes after stenting of mesenteric arteries using BMS or CS. Study Outcome: Primary stent patency 1 year after placement The trial will also evaluate complications, how often stents need to be reoperated, Quality of Life (QoL) and reasons for subjects death Method: This is a so called prospective, randomized controlled trial comparing CS vs. BMS. This means that one patients have agrred to treatment they will be randomly selected for treatment with either CS or BMS . The stent metal structure is identical in the two implants and the only difference is the graft covering, making this study unique. The study will also collect blood samples for a biobank that will be used to study markers of disease and how these effect treatment outcomes. All patients referred to the Department of Vascular Surgery due to CMI are considered for inclusion if they havechronic symptoms consistent with CMI, significant stenosis or occlusion of the superior mesenteric artery and are \> 18 years Subjects not able to provide informed consent or who have non atherosclerotic cause of CMI, signs of acute loss of blood flow to the intestines cannot participate. Previous stent treatment in the superior mesenteric artery, pregnancy, allergies to contrast or stent materials are also reasons for not being included in this trial. Side effects, risks and disadvantages for participants The risk for procedure-related complications is less than 5% and similar in both study groups. Most short-term complications are related to vascular access sites and consist of local bleeding and thrombosis. Other potential complications include impaired renal function due to contrast use, contrast allergy, arterial dissection and death.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Denmark
Department of Vascular Surgery, Heart Center, Copenhagen University Hospital - Rigshospitalet
RECRUITING
København Ø
Contact Information
Primary
Timothy A Resch, MD, PhD
timothy.andrew.resch@regionh.dk
+45 35 45 79 31
Backup
Jonas Eiberg, MD, PhD
jonas.peter.eiberg@regionh.dk
+45 35 45 24 08
Time Frame
Start Date: 2023-06
Estimated Completion Date: 2029-08
Participants
Target number of participants: 98
Treatments
Active_comparator: Bare Metal Stent
Active_comparator: Covered Stent
Related Therapeutic Areas
Sponsors
Collaborators: University of Copenhagen
Leads: Rigshospitalet, Denmark

This content was sourced from clinicaltrials.gov