Covered Stents Versus Bare-Metal Stents

Arteriosclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02428582
• Other study ID #: MEC-2013-476
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 2016
• Est. completion date: November 2021

Study information

• Verified date: March 2021
• Source: Erasmus Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 84
• Est. completion date: November 2021
• Est. primary completion date: November 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Netherlands	ErasmusMC	Rotterdam	Zuid Holland

Sponsors (1)

Lead Sponsor	Collaborator
Erasmus Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	The clinical outcome in terms therapeutic and total costs after 6-, 12- and 24- months after stent implantation		6 to 24 month