ClinConnect ClinConnect Logo
Search / Trial NCT02428582

Covered Stents Versus Bare-Metal Stents

Launched by ERASMUS MEDICAL CENTER · Apr 28, 2015

Trial Information

Current as of May 12, 2025

Unknown status

Keywords

Endovascular Treatment Arterial Occlusive Disease Bare Metal Stent Polytetrafluoroethylene Covered Stent

ClinConnect Summary

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 o...

Gender

ALL

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

About Erasmus Medical Center

Erasmus Medical Center, located in Rotterdam, Netherlands, is a leading academic medical center renowned for its commitment to advancing healthcare through innovative research and clinical trials. As a prominent institution within the Erasmus University Rotterdam, the center integrates cutting-edge scientific inquiry with comprehensive patient care, focusing on a wide range of medical specialties. With a strong emphasis on multidisciplinary collaboration, Erasmus Medical Center aims to translate research findings into tangible clinical applications, enhancing treatment options and improving patient outcomes. The institution is dedicated to conducting ethical and rigorous clinical trials that contribute to the global body of medical knowledge and foster advancements in personalized medicine.

Locations

Rotterdam, Zuid Holland, Netherlands

Patients applied

0 patients applied

Trial Officials

Adriaan Moelker, dr

Principal Investigator

Erasmus Medical Center

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Similar Trials