Gastrointestinal Vascular ConditionsNCT02428582
Covered Stents Versus Bare-Metal Stents
A study testing Covered stent (Atrium Type V12) and Bare stent (Brand Cordis Type Palmaz Blue) in people with Gastrointestinal Vascular Conditions and Arteriosclerosis, run by Erasmus Medical Center at 1 site in Netherlands.
Trial summary
To compare the outcome of revascularisation the gastrointestinal arteries using covered stents compared to bare-metal stents in patients with CGI. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Vascular Conditions, Arteriosclerosis, Lifestyle-related Condition
- What is being tested?
- Covered stent (Atrium Type V12) and Bare stent (Brand Cordis Type Palmaz Blue)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteNetherlands
- Study dates
- May 2016to Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- Patients over the age of 18 years.
- Patients who gave informed consent.
- Patients have sustained atherosclerosis.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Gastrointestinal Vascular Conditions, Arteriosclerosis, Lifestyle-related Condition, Stenosis, Vascular Insufficiency, Necrosis
- Being tested
- Covered stent (Atrium Type V12), Bare stent (Brand Cordis Type Palmaz Blue)
- Keywords
- endovascular treatment, arterial occlusive disease, bare metal stent, polytetrafluoroethylene covered stent
- Medical subject headings
- Arteriosclerosis, Mental Disorders, Constriction, Pathologic, Necrosis, Arterial Occlusive Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Covered stent (Atrium Type V12)Device
An endovascular treatment that consists of inserting a covered stent into the stenosed vessels.
Bare stent (Brand Cordis Type Palmaz Blue)Device
Also called Brand Cordis Type Palmaz Blue
An endovascular treatment that consists of inserting a stent into the stenosed vessels.
| Study group | Role | What they receive |
|---|---|---|
| bare stent inserted | Active comparator | Standard bare stent will be placed Receives: Device: Bare stent (Brand Cordis Type Palmaz Blue) |
| Covered stent inserted | Experimental | Covered stent will be placed Receives: Device: Covered stent (Atrium Type V12) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference of primary and secondary patency rates of covered stents versus bare-metal stents to treat atherosclerotic CGI disease.
Measured: 12 to 24 months
Secondary outcomes (5)
The freedom from restenosis 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
Measured: 6 to 24 month
The freedom from symptom recurrence after 6-, 12- and 24- months after stent implantation
Symptom recurrence is defined as occurrence of clinical symptoms typical for CGI regardless of stent patency
Measured: 6 to 24 month
The freedom from reintervention after 6-, 12- and 24- months after stent implantation
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.
Measured: 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
Measured: 6 to 24 month
The clinical outcome in terms therapeutic and total costs after 6-, 12- and 24- months after stent implantation
Measured: 6 to 24 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2015 (estimated)
- Study startMay 2016
- Primary completionNov 2021 (estimated)
- Study completionNov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gastrointestinal Vascular ConditionsStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Trialbureau radiology, Erasmus Medical Center
- Investigators
- Adriaan Moelker, dr, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02428582
- Sponsor's protocol ID
- MEC-2013-476
- Status last verified
- Mar 2021
- First submitted
- 15 Apr 2015
- Last updated
- 9 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Terlouw LG, van Dijk LJD, van Noord D, Bakker OJ, Bijdevaate DC, Erler NS, Fioole B, Harki J, van den Heuvel DAF, Hinnen JW, Kolkman JJ, Nikkessen S, van Petersen AS, Smits HFM, Verhagen HJM, de Vries AC, de Vries JPM, Vroegindeweij D, Geelkerken RH, Bruno MJ, Moelker A; Dutch Mesenteric Ischemia Study Group. Covered versus bare-metal stenting of the mesenteric arteries in patients with chronic mesenteric ischaemia (CoBaGI): a multicentre, patient-blinded and investigator-blinded, randomised controlled trial. Lancet Gastroenterol Hepatol. 2024 Apr;9(4):299-309. doi: 10.1016/S2468-1253(23)00402-8. Epub 2024 Jan 29.
PubMed 38301673van Dijk LJD, Harki J, van Noord D, Verhagen HJM, Kolkman JJ, Geelkerken RH, Bruno MJ, Moelker A; Dutch Mesenteric Ischemia Study group (DMIS). Covered stents versus Bare-metal stents in chronic atherosclerotic Gastrointestinal Ischemia (CoBaGI): study protocol for a randomized controlled trial. Trials. 2019 Aug 20;20(1):519. doi: 10.1186/s13063-019-3609-8.
PubMed 31429792
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Covered Stents Versus Bare-Metal Stents in Chronic Atherosclerotic Gastrointestinal Ischemia
- ClinicalTrials.gov ID
- NCT02428582
- Acronym / sponsor ID
- MEC-2013-476
- Conditions
- Gastrointestinal Vascular Conditions, Arteriosclerosis, Lifestyle-related Condition, Stenosis, Vascular Insufficiency, Necrosis
- Keywords
- endovascular treatment, arterial occlusive disease, bare metal stent, polytetrafluoroethylene covered stent
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Nov 2021 (estimated)
- Study completion
- Nov 2021 (estimated)
- First posted
- 29 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the outcome of revascularisation the gastrointestinal arteries using covered stents compared to bare-metal stents in patients with CGI.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bare stent inserted | Active comparator | Device: Bare stent (Brand Cordis Type Palmaz Blue)Standard bare stent will be placed |
| Covered stent inserted | Experimental | Device: Covered stent (Atrium Type V12)Covered stent will be placed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Covered stent (Atrium Type V12)An endovascular treatment that consists of inserting a covered stent into the stenosed vessels. | Device | Covered stent inserted |
| Bare stent (Brand Cordis Type Palmaz Blue)Also: Brand Cordis Type Palmaz BlueAn endovascular treatment that consists of inserting a stent into the stenosed vessels. | Device | bare stent inserted |
Primary outcome
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
5 secondary outcomes
The freedom from restenosis after 6-, 12- and 24- months after stent implantation
Time frame: 6 to 24 month
The freedom from symptom recurrence after 6-, 12- and 24- months after stent implantation
Time frame: 6 to 24 month
The freedom from reintervention after 6-, 12- and 24- months after stent implantation
Time frame: 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
The clinical outcome in terms therapeutic and total costs after 6-, 12- and 24- months after stent implantation
Time frame: 6 to 24 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2021.
- Derived from this study: PubMed 38301673Terlouw LG, van Dijk LJD, van Noord D, Bakker OJ, Bijdevaate DC, Erler NS, Fioole B, Harki J, van den Heuvel DAF, Hinnen JW, Kolkman JJ, Nikkessen S, van Petersen AS, Smits HFM, Verhagen HJM, de Vries AC, de Vries JPM, Vroegindeweij D, Geelkerken RH, Bruno MJ, Moelker A; Dutch Mesenteric Ischemia Study Group. Covered versus bare-metal stenting of the mesenteric arteries in patients with chronic mesenteric ischaemia (CoBaGI): a multicentre, patient-blinded and investigator-blinded, randomised controlled trial. Lancet Gastroenterol Hepatol. 2024 Apr;9(4):299-309. doi: 10.1016/S2468-1253(23)00402-8. Epub 2024 Jan 29.
- Derived from this study: PubMed 31429792van Dijk LJD, Harki J, van Noord D, Verhagen HJM, Kolkman JJ, Geelkerken RH, Bruno MJ, Moelker A; Dutch Mesenteric Ischemia Study group (DMIS). Covered stents versus Bare-metal stents in chronic atherosclerotic Gastrointestinal Ischemia (CoBaGI): study protocol for a randomized controlled trial. Trials. 2019 Aug 20;20(1):519. doi: 10.1186/s13063-019-3609-8.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adriaan Moelker, dr principal investigator
Erasmus Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Covered stent (Atrium Type V12) and Bare stent (Brand Cordis Type Palmaz Blue) in people with Gastrointestinal Vascular Conditions and Arteriosclerosis, run by Erasmus Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02428582, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2021.