Covered Stents Versus Bare-Metal Stents

March 8, 2021 updated by: Trialbureau radiology, Erasmus Medical Center

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

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

84

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Zuid Holland
      • Rotterdam, Zuid Holland, Netherlands, 3015CE
        • ErasmusMC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The difference of primary and secondary patency rates of covered stents versus bare-metal stents to treat atherosclerotic CGI disease.
Time Frame: 12 to 24 months
12 to 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The freedom from restenosis after 6-, 12- and 24- months after stent implantation
Time Frame: 6 to 24 month
Restenosis is defined as >50% intra-stent stenosis regardless of whether the patient has clinical symptoms
6 to 24 month
The freedom from symptom recurrence after 6-, 12- and 24- months after stent implantation
Time Frame: 6 to 24 month
Symptom recurrence is defined as occurrence of clinical symptoms typical for CGI regardless of stent patency
6 to 24 month
The freedom from reintervention after 6-, 12- and 24- months after stent implantation
Time Frame: 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.
6 to 24 month
The clinical outcome in terms of quality of life and therapeutic and total costs after 6-, 12- and 24- months after stent implantation
Time Frame: 6 to 24 month
6 to 24 month
The clinical outcome in terms therapeutic and total costs after 6-, 12- and 24- months after stent implantation
Time Frame: 6 to 24 month
6 to 24 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Erasmus Medical Center

Investigators

  • Principal Investigator: Adriaan Moelker, dr, Erasmus Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Anticipated)

November 1, 2021

Study Completion (Anticipated)

November 1, 2021

Study Registration Dates

First Submitted

April 15, 2015

First Submitted That Met QC Criteria

April 28, 2015

First Posted (Estimate)

April 29, 2015

Study Record Updates

Last Update Posted (Actual)

March 9, 2021

Last Update Submitted That Met QC Criteria

March 8, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MEC-2013-476

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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