To compare the outcome of revascularisation the gastrointestinal arteries using covered stents compared to bare-metal stents in patients with CGI.
ID
Source
Brief title
Condition
- Gastrointestinal vascular conditions
- Lifestyle issues
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Compare the primary and secondary patency rates of covered stents versus
bare-metal stents to treat atherosclerotic CGI disease.
Secondary outcome
Freedom from restenosis, from symptom recurrence and from reintervention, and
clinical outcome in terms of quality of life and therapeutic and total costs
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.
Symptom recurrence is defined as occurrence of clinical symptoms typical for
CGI regardless of stent patency
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.
Background 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
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 objective
To compare the outcome of revascularisation the gastrointestinal arteries using
covered stents compared to bare-metal stents in patients with CGI.
Study design
A prospective, randomized controlled trial will be performed. Patients with CGI
with stenosis or occlusion of at least one of the three gastrointestinal
arteries and with indication of implantation of a stent, will be randomly
assigned to receive a covered stent or bare-metal stent. Patient demographic
data, clinical signs and symptoms will be recorded. Patients will be
followed-up at 6-, 12- and 24- months with CTA to confirm stent patency and at
baseline and at follow-up they will be asked to fill in the questionnaires
about quality of life and effectiveness of the treatment.
Intervention
An endovascular treatment that consists of inserting a stent into the stenosed
vessels.
Study burden and risks
This prospective study will provide valuable information about the primary and
secondary patency rates of covered stents in endovascular treatment of
atherosclerotic CGI, the quality of life of both arm of the study population
and the cost-effectiveness of implantation of covered stents or bare metal
stents. Complication rate of these two different stents are similar. It is
expected that patients receiving a covered stent will benefit from better
patency rates.
Patients have to undergo 3 additional low-dose CTA in 2 years, but CTA only
focused on the gastrointestinal arteries with a scan dose of approximately 1
mSv. The patient will receive in 10 years approximately extra 3 mSv, with an
average of 1.7 mSv / year. The natural background in Netherlands is 2mSv and
the natural background in U.S. is 3mSv, so basically we just increase the
irradiation of the patient from natural background of Netherlands to natural
background of U.S., wich makes it not more harmful than living in U.S.(8)
During the study patients fill in a short, validated questionnaire once prior
to and 6, 12 and 24 months after stentplacement. Filling in the questionnaire
is simple and only takes 5 minutes.
's Gravendijkwal 230
Rotterdam 3015 CE
NL
's Gravendijkwal 230
Rotterdam 3015 CE
NL
Listed location countries
Age
Inclusion criteria
1. 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:
- Typical history (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 not older than one year, with maximum slice thickness 1 mm and
enhancement in aorta of 300HU
- Mucosal ischemia detedcted by VLS or tonometry
2. Patients over the age of 18 years
3. Patients who gave informed consent
4. Patients have sustained atherosclerosis.
5. Total length of stenosis < 25 mm
Exclusion criteria
1. Patients who don*t give informed consent
2. Age < 18 years
3. No stenosis detected during arteriography
4. Renal insufficiency (GFR below 30 ml/min or GFR below 60 ml/min when
comorbidities relevant to kidney function present).
5. Previous stent placement in the to be treated gastrointestinal artery
6. Pregnancy
7. Celiac artery compression syndrome
8. Vasculitis
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT02428582 |
| CCMO | NL46337.078.13 |