Clinical trial NCT02428582: Covered Stents Versus Bare-Metal Stents
Official title: Covered Stents Versus Bare-Metal Stents in Chronic Atherosclerotic Gastrointestinal Ischemia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastrointestinal Vascular Conditions
Arteriosclerosis
Lifestyle-related Condition
Stenosis
Vascular Insufficiency
Necrosis
Keywords: endovascular treatment
arterial occlusive disease
bare metal stent
polytetrafluoroethylene covered stent
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
First posted: 2015-04-29
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The difference of primary and secondary patency rates of covered stents versus bare-metal stents to treat atherosclerotic CGI disease.
timeFrame: 12 to 24 months
Secondary outcomes:
measure: The freedom from restenosis after 6-, 12- and 24- months after stent implantation
timeFrame: 6 to 24 month
measure: The freedom from symptom recurrence after 6-, 12- and 24- months after stent implantation
timeFrame: 6 to 24 month
measure: The freedom from reintervention after 6-, 12- and 24- months after stent implantation
timeFrame: 6 to 24 month
measure: The clinical outcome in terms of quality of life and therapeutic and total costs after 6-, 12- and 24- months after stent implantation
timeFrame: 6 to 24 month
measure: The clinical outcome in terms therapeutic and total costs after 6-, 12- and 24- months after stent implantation
timeFrame: 6 to 24 month
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: ErasmusMC
state: Zuid Holland
Study officials:
affiliation: Erasmus Medical Center
name: Adriaan Moelker, dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: van Dijk LJD, Harki J, van Noord D, Verhagen HJM, Kolkman JJ, Geelkerken RH, Bruno MJ, Moelker A; Dutch Mesenteric Ischemia Study group (DMIS). Covered stents versus Bare-metal stents in chronic atherosclerotic Gastrointestinal Ischemia (CoBaGI): study protocol for a randomized controlled trial. Trials. 2019 Aug 20;20(1):519. doi: 10.1186/s13063-019-3609-8.