Covered Stents Versus Bare-Metal Stents

Sponsor

Erasmus Medical Center (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT02428582

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Gastrointestinal Vascular Conditions Arteriosclerosis Lifestyle-related Condition Stenosis Vascular Insufficiency Necrosis	Device: Covered stent (Atrium Type V12) Device: Bare stent (Brand Cordis Type Palmaz Blue)	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

84 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

May 1, 2016

Anticipated Primary Completion Date :

Nov 1, 2021

Anticipated Study Completion Date :

Nov 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: bare stent inserted Standard bare stent will be placed	Device: Bare stent (Brand Cordis Type Palmaz Blue) An endovascular treatment that consists of inserting a stent into the stenosed vessels. Other Names: Brand Cordis Type Palmaz Blue
Experimental: Covered stent inserted Covered stent will be placed	Device: Covered stent (Atrium Type V12) An endovascular treatment that consists of inserting a covered stent into the stenosed vessels.

Arm

Intervention/Treatment

Active Comparator: bare stent inserted

Standard bare stent will be placed

Device: Bare stent (Brand Cordis Type Palmaz Blue)

An endovascular treatment that consists of inserting a stent into the stenosed vessels.

Other Names:

Brand Cordis Type Palmaz Blue

Experimental: Covered stent inserted

Covered stent will be placed

Device: Covered stent (Atrium Type V12)

An endovascular treatment that consists of inserting a covered stent into the stenosed vessels.

Outcome Measures

Primary Outcome Measures

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

The freedom from restenosis after 6-, 12- and 24- months after stent implantation [6 to 24 month]
Restenosis is defined as >50% intra-stent stenosis regardless of whether the patient has clinical symptoms
The freedom from symptom recurrence after 6-, 12- and 24- months after stent implantation [6 to 24 month]
Symptom recurrence is defined as occurrence of clinical symptoms typical for CGI regardless of stent patency
The freedom from reintervention after 6-, 12- and 24- months after stent implantation [6 to 24 month]
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.
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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