treatment of bowel ischemia. treatment of mesenteric ischemia
Conditions
Interventions
An endovascular treatment that consists of inserting a stent into the stenosed
vessels.
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Patients with consensus diagnostic of CGI based on a clinical meeting with a gastroenterologist, a vascular surgeon and an interventional radiologist. Diagnostic consensus of CGI is based on: - Typical history (presence of postprandial pain, unexplained weight loss (>5% of normal body weight) - Significant stenosis of >50% of at least one of the gastrointestinal arteries on a recent CTA not older than one year, with maximum slice thickness 1 mm and enhancement in aorta of 300HU - Mucosal ischemia detedcted by VLS or tonometry 2. Patients over the age of 18 years 3. Patients who gave informed consent 4. Patients have sustained atherosclerosis. 5. Total length of stenosis
Exclusion criteria
Exclusion criteria: 1. Patients who don*t give informed consent 2. Age
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Compare the primary and secondary patency rates of covered stents versus bare-metal stents to treat atherosclerotic CGI disease. | — |
Secondary
| Measure | Time frame |
|---|---|
| Freedom from restenosis, from symptom recurrence and from reintervention, and clinical outcome in terms of quality of life and therapeutic and total costs after 6-, 12- and 24- months after stent implantation. Restenosis is defined as >50% intra-stent stenosis regardless of whether the patient has clinical symptoms. Symptom recurrence is defined as occurrence of clinical symptoms typical for CGI regardless of stent patency Re-intervention is defined as intervention due to symptom occurrence in the presence of >50% intra -stenosis, either a reimplantation of stent or a surgical procedure. | — |
Countries
Netherlands
Outcome results
None listed