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Prevention study for Mesenteric Vascular Disease
Official title Anastomotic Leakage Prevention by Endovascular Stenting of the Superior Mesenteric Artery
ClinicalTrials.gov ID: NCT07486570
What this study is testing
What is Mono antiplatelet therapy with Ascal 80mg daily?
Mono antiplatelet therapy with Ascal 80mg daily is an investigational medicine, given as an once-daily, being studied as a potential treatment for mesenteric vascular disease.
Also referred to as Carbasalate Calcium, Ascal ®.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Rationale: Anastomotic leakage (AL) is a severe complication of colon surgery, with an incidence of 2.7-11.9%. It is associated with long-term increased mortality, reduced quality of life, and high healthcare costs due to reoperations and prolonged hospitalization.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 and older
You may be able to join if
- Age \>40 years.
- Patient scheduled for elective colon resection above the recto-sigmoid junction with a primary anastomosis (side-to-side, side-to-end, or end-to-end).
- Presence of an asymptomatic \>50% atherosclerotic origin stenosis of the superior mesenteric artery (SMA)
You likely can't join if
- All patients with symptomatic chronic or acute mesenteric ischemia (i.e., mesenteric artery stenosis in combination with symptoms as postprandial...
- Presence of a \>50% stenosis of the celiac artery, regardless of the underlying pathology (i.e., intra-articular atherosclerosis, intra articular...
- Simultaneous performed during the colon resection: a substantial abdominal organ resection, or T4b/T4c colon tumour resection, or a second colon...
- History of mesenteric revascularization, including endovascular stenting, thrombectomy, or bypass surgery involving any of the mesenteric arteries
- Patients with a history of heparin induced thrombocytopenia-type 2 due to contraindication for VBX Stent Graft.
- Patients with a contra-indication for mono antiplatelet therapy with Ascal due to comorbidities, allergy or intolerance.
See the full eligibility criteria
- Age \>40 years.
- Patient scheduled for elective colon resection above the recto-sigmoid junction with a primary anastomosis (side-to-side, side-to-end, or end-to-end).
- Presence of an asymptomatic \>50% atherosclerotic origin stenosis of the superior mesenteric artery (SMA)
- All patients with symptomatic chronic or acute mesenteric ischemia (i.e., mesenteric artery stenosis in combination with symptoms as postprandial abdominal pain, fear of eating, altered eating patterns, weight loss...
- Presence of a \>50% stenosis of the celiac artery, regardless of the underlying pathology (i.e., intra-articular atherosclerosis, intra articular thrombus or external compression by the median accurate ligament).
- Simultaneous performed during the colon resection: a substantial abdominal organ resection, or T4b/T4c colon tumour resection, or a second colon anastomosis or a diverting stoma
- History of mesenteric revascularization, including endovascular stenting, thrombectomy, or bypass surgery involving any of the mesenteric arteries
- Patients with a history of heparin induced thrombocytopenia-type 2 due to contraindication for VBX Stent Graft.
- Patients with a contra-indication for mono antiplatelet therapy with Ascal due to comorbidities, allergy or intolerance.
- Pregnancy
The study team makes the final eligibility decision.
Where it's taking place
- Apeldoorn, Gelderland, Netherlands
- Heerlen, Limburg, Netherlands
- Maastricht, Limburg, Netherlands
- 's-Hertogenbosch, North Brabant, Netherlands
- Alkmaar, North Holland, Netherlands
- Almelo, Overijsel, Netherlands
- Enschede, Overijsel, Netherlands
- Drachten, Provincie Friesland, Netherlands
- Rotterdam, South Holland, Netherlands
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Apeldoorn, Gelderland, Netherlands; Heerlen, Limburg, Netherlands; Maastricht, Limburg, Netherlands; 's-Hertogenbosch, North Brabant, Netherlands; Alkmaar, North Holland, Netherlands; Almelo, Overijsel, Netherlands and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.