NCT02428582

Covered Stents Versus Bare-Metal Stents

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 84 (estimated)
• Sponsor: Erasmus Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
DEVICE	Covered stent (Atrium Type V12)	An endovascular treatment that consists of inserting a covered stent into the stenosed vessels.
DEVICE	Bare stent (Brand Cordis Type Palmaz Blue)	An endovascular treatment that consists of inserting a stent into the stenosed vessels.

Timeline

• Start date: 2016-05-01
• Primary completion: 2021-11-01
• Completion: 2021-11-01
• First posted: 2015-04-29
• Last updated: 2021-03-09

Locations

1 site across 1 country: Netherlands