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To compare the outcome of revascularisation the gastrointestinal arteries using covered stents compared to bare-metal stents in patients with CGI.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| bare stent inserted | Active Comparator | Standard bare stent will be placed |
|
| Covered stent inserted | Experimental | Covered stent will be placed |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Covered stent (Atrium Type V12) | Device | An endovascular treatment that consists of inserting a covered stent into the stenosed vessels. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The difference of primary and secondary patency rates of covered stents versus bare-metal stents to treat atherosclerotic CGI disease. | 12 to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 to 24 month |
| The freedom from symptom recurrence after 6-, 12- and 24- months after stent implantation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adriaan Moelker, dr | Erasmus Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ErasmusMC | Rotterdam | South Holland | 3015CE | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38301673 | Derived | 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. | |
| 31429792 |
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| ID | Term |
|---|---|
| D001161 | Arteriosclerosis |
| D001523 | Mental Disorders |
| D003251 | Constriction, Pathologic |
| D009336 | Necrosis |
| D001157 | Arterial Occlusive Diseases |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Bare stent (Brand Cordis Type Palmaz Blue) | Device | An endovascular treatment that consists of inserting a stent into the stenosed vessels. |
|
|
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 | 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 | 6 to 24 month |
| The clinical outcome in terms therapeutic and total costs after 6-, 12- and 24- months after stent implantation | 6 to 24 month |
| Derived |
| van 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. |
| D010335 | Pathologic Processes |