Covered Stents Versus Bare-Metal Stents

Study Overview
=================
Brief Summary
-----------------
To compare the outcome of revascularisation the gastrointestinal arteries using covered stents compared to bare-metal stents in patients with CGI.

Detailed Description
-----------------
Symptomatic chronic atherosclerotic gastrointestinal ischemia (CGI) is an uncommon, potentially underdiagnosed condition caused by fixed stenosis or occlusion of in most conditions at least one of the three gastrointestinal arteries. Atherosclerosis is a predisposing factor for CGI. Clinical symptoms can vary widely. Typical symptoms are postprandial abdominal pain, unintended weight loss and food avoidance. But atypical abdominal pain such as exercise related pain, diarrhoea and nausea can also indicate CGI. The use of endovascular techniques for revascularization of chronic stenosis and occlusions of the gastrointestinal arteries has rapidly increased and endovascular therapy with stenting has become the most common method chosen for revascularization, having replaced open surgery with its associated morbidity and mortality. Nowadays standard care in significant chronic gastrointestinal ischemia is the use of bare metal stents although the patency of these stents is not very high. According retrospective data the patency of covered stents is significantly higher compared to bare metal stents. One likely explanation for these lower restenosis and re-intervention rates observed with covered stents is the established barrier to tissue ingrowth. Only recent retrospective data about this topic is available but the expectancy in this prospective study is that the patency of covered stents is indeed higher compared to metal stents.

Official Title
-----------------
Covered Stents Versus Bare-Metal Stents in Chronic Atherosclerotic Gastrointestinal Ischemia

Conditions
-----------------
Stenosis, Gastrointestinal Vascular Conditions, Arteriosclerosis, Lifestyle-related Condition, Vascular Insufficiency, Necrosis

Intervention / Treatment
-----------------
* Device: Covered stent (Atrium Type V12)
* Device: Bare stent (Brand Cordis Type Palmaz Blue)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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. 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 (Computer Tomographic Angiography) not older than one year, with maximum slice thickness 1 mm and enhancement in aorta of 300HU (Hounsfields Units) Mucosal ischemia detected by VLS (Visible Light Spectroscopy) or tonometry Patients over the age of 18 years. Patients who gave informed consent. Patients have sustained atherosclerosis. Exclusion Criteria: Patients who don't give informed consent. Age < 18 years No stenosis detected during arteriography. Renal insufficiency (GFR below 30 ml/min or GFR below 60 ml/min when comorbidities relevant to kidney function present). Previous stent placement in the to be treated gastrointestinal artery. Pregnancy Celiac artery compression syndrome. Vasculitis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: bare stent inserted<br>Standard bare stent will be placed | Device: Bare stent (Brand Cordis Type Palmaz Blue)<br>* An endovascular treatment that consists of inserting a stent into the stenosed vessels.<br>* Other names: Brand Cordis Type Palmaz Blue;|
| Experimental: Covered stent inserted<br>Covered stent will be placed | Device: Covered stent (Atrium Type V12)<br>* An endovascular treatment that consists of inserting a covered stent into the stenosed vessels.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The difference of primary and secondary patency rates of covered stents versus bare-metal stents to treat atherosclerotic CGI disease. |  | 12 to 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The freedom from restenosis 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 | 6 to 24 month | 
| The freedom from symptom recurrence after 6-, 12- and 24- months after stent implantation | Symptom recurrence is defined as occurrence of clinical symptoms typical for CGI regardless of stent patency | 6 to 24 month | 
| The freedom from reintervention after 6-, 12- and 24- months after stent implantation | 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. | 6 to 24 month | 
| The clinical outcome in terms of quality of life and therapeutic and total costs after 6-, 12- and 24- months after stent implantation |  | 6 to 24 month | 
| The clinical outcome in terms therapeutic and total costs after 6-, 12- and 24- months after stent implantation |  | 6 to 24 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
endovascular treatment, arterial occlusive disease, bare metal stent, polytetrafluoroethylene covered stent