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

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. Guidelines increasingly support the use of so called covered stents (CS) in stead of bare stents (BMS) for this use but the level of evidence for this is limited. Using CS incur additional costs for healthcare short-term but may prevent recurrence of narrowing and symptoms postoperatively benefitting patients and healthcare.

Study 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.

Study Overview

• Status: Recruiting
• Conditions: Mesenteric Ischemia; Stent Thrombosis; Stent Restenosis; Stent-Graft Restenosis; Stent-Graft Thrombosis; Stent-Graft Stenosis; Stent Occlusion; Bowel; Ischemic; Superior Mesenteric Atherosclerosis; Mesenteric Artery Stenosis
• Intervention / Treatment: Device: BMS vs. CS

• Study Type: Interventional
• Enrollment (Estimated): 98
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Timothy A Resch, MD, PhD; Phone Number: 57931 +45 35 45 79 31; Email: timothy.andrew.resch@regionh.dk
• Study Contact Backup: Name: Jonas Eiberg, MD, PhD; Phone Number: +45 35 45 24 08; Email: jonas.peter.eiberg@regionh.dk

Study Locations

• Denmark
  • København ø, Denmark, 2100
    • Recruiting
    • Department of Vascular Surgery, Heart Center, Copenhagen University Hospital - Rigshospitalet
    • Sub-Investigator: Jonas Eiberg, Prof
    • Sub-Investigator: Lars Lønn, Prof
    • Sub-Investigator: Mikkel Taudorff, MD, PhD
    • Contact: Sofie Phillipsen, RN; Email: sophie.phillipsen@regionh.dk
    • Contact: Alexandra Brandtzæg, MD; Email: alexandra.annelie.brandtzaeg@regionh.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Bare Metal Stent	Device: BMS vs. CS; Patients will be randomized to treatment with either BeSmooth (BMS, Bentley Innomed GmBh) or BeGraft (CS, Bentley Innomed Gmbh)
Active Comparator: Covered Stent	Device: BMS vs. CS; Patients will be randomized to treatment with either BeSmooth (BMS, Bentley Innomed GmBh) or BeGraft (CS, Bentley Innomed Gmbh)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with open stents after 12 months	No evidence of occlusion, thrombosis or in-stent restenosis more than 30 percent	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival	reintervention free and overall survival	5 years
Quality of life accoring to SF 36 variables	SF 36	5 years

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Collaborators: University of Copenhagen
• Investigators: Principal Investigator: Timothy A Resch, MD, PhD, Deptarment of Vascular Surgery, Rigshospitalet

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2023
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): August 1, 2029

Study Registration Dates

• First Submitted: February 8, 2022
• First Submitted That Met QC Criteria: February 8, 2022
• First Posted (Actual): February 17, 2022

Study Record Updates

• Last Update Posted (Actual): June 12, 2023
• Last Update Submitted That Met QC Criteria: June 9, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Peritoneal Diseases; Gastrointestinal Diseases; Embolism and Thrombosis; Intestinal Diseases; Pathological Conditions, Anatomical; Ischemia; Thrombosis; Constriction, Pathologic; Atherosclerosis; Mesenteric Ischemia
• Other Study ID Numbers: 88754

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No