Covered Stents versus Bare-Metal Stents in Chronic Atherosclerotic Gastrointestinal Ischemia

Recruiting

Conditions: treatment of bowel ischemia.
treatment of mesenteric ischemia
10018031
10024450
10003216

Registration Number: NL-OMON47639

Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 84

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 < 25 mm

Exclusion Criteria

1. Patients who don*t give informed consent
2. Age < 18 years
3. No stenosis detected during arteriography
4. Renal insufficiency (GFR below 30 ml/min or GFR below 60 ml/min when
comorbidities relevant to kidney function present).
5. Previous stent placement in the to be treated gastrointestinal artery
6. Pregnancy
7. Celiac artery compression syndrome
8. Vasculitis

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Compare the primary and secondary patency rates of covered stents versus<br /><br>bare-metal stents to treat atherosclerotic CGI disease.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Freedom from restenosis, from symptom recurrence and from reintervention, and<br /><br>clinical outcome in terms of quality of life and therapeutic and total costs<br /><br>after 6-, 12- and 24- months after stent implantation.<br /><br>Restenosis is defined as >50% intra-stent stenosis regardless of whether the<br /><br>patient has clinical symptoms.<br /><br>Symptom recurrence is defined as occurrence of clinical symptoms typical for<br /><br>CGI regardless of stent patency<br /><br>Re-intervention is defined as intervention due to symptom occurrence in the<br /><br>presence of >50% intra -stenosis, either a reimplantation of stent or a<br /><br>surgical procedure. </p><br>