Covered Stents Versus Bare-Metal Stents

Erasmus University

Status: Unknown

Conditions: Vascular Insufficiency; Arteriosclerosis; Gastrointestinal Vascular Conditions; Necrosis; Stenosis; Lifestyle-related Condition

Treatments: Device: Bare stent (Brand Cordis Type Palmaz Blue); Device: Covered stent (Atrium Type V12)

Study type: Interventional

Funder types: Other

Identifiers

NCT02428582

MEC-2013-476

Details and patient eligibility

About

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

Full 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.

Enrollment: 84 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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84 participants in 2 patient groups

bare stent inserted

Active Comparator group

Description:

Standard bare stent will be placed

Treatment:

Device: Bare stent (Brand Cordis Type Palmaz Blue)

Covered stent inserted

Experimental group

Description:

Covered stent will be placed

Treatment:

Device: Covered stent (Atrium Type V12)