ClinicalTrials.gov
ClinicalTrials.gov Menu

Covered Stents Versus Bare-Metal Stents

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02428582
Recruitment Status : Recruiting
First Posted : April 29, 2015
Last Update Posted : January 31, 2018
Sponsor:
Information provided by (Responsible Party):
Trialbureau radiology, Erasmus Medical Center

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) Not Applicable

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  (Clinical Trial)
Estimated 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 2016
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : November 2018

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 Name: 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.



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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.

  4. 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 ]
  5. The clinical outcome in terms therapeutic and total costs after 6-, 12- and 24- months after stent implantation [ Time Frame: 6 to 24 month ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02428582


Contacts
Contact: Louisa van Dijk, drs l.vandijk@erasmusmc.nl
Contact: laurens Groenendijk 31 10 7033666 imaging.trialbureau@erasmusmc.nl

Locations
Netherlands
ErasmusMC Recruiting
Rotterdam, Zuid Holland, Netherlands, 3015CE
Sponsors and Collaborators
Erasmus Medical Center
Investigators
Principal Investigator: Adriaan Moelker, dr Erasmus Medical Center

Responsible Party: Trialbureau radiology, Coordinating trialbureau, Erasmus Medical Center
ClinicalTrials.gov Identifier: NCT02428582     History of Changes
Other Study ID Numbers: MEC-2013-476
First Posted: April 29, 2015    Key Record Dates
Last Update Posted: January 31, 2018
Last Verified: January 2018

Keywords provided by Trialbureau radiology, Erasmus Medical Center:
endovascular treatment
arterial occlusive disease
bare metal stent
polytetrafluoroethylene covered stent

Additional relevant MeSH terms:
Disease
Necrosis
Arteriosclerosis
Pathologic Processes
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases