ACtive Catheterization for EndovaScular TreatmentS (NCT05355259) | Clinical Trial Compass
CompletedNot Applicable
ACtive Catheterization for EndovaScular TreatmentS
France10 participantsStarted 2022-06-27
Plain-language summary
The objective of this clinical investigation is to evaluate the safety and technical success of the Basecamp Vascular controllable directional GECKO guidewire when used to facilitate endovascular access to the targeted vessel in order to treat the vascular lesion.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Male or female ≥18 years old.
✓. An unruptured intracranial aneurysm, a brain arteriovenous malformation (bAVM) or dural arteriovenous fistula (DAVF) or an internal carotid artery (ICA) stenosis.
✓. Subject can receive, if necessary, anti-coagulation and anti-platelet therapy according to the standard used in each study center.
✓. Subject is eligible to undergo a procedure with the use of contrast media.
✓. Subject is willing to comply with protocol requirements and return to the treatment center for all required clinical evaluations and follow-up.
✓. Subject has given written informed consent.
✓. Life expectancy \>12 months.
Exclusion criteria
✕. Subject is unconscious and unable to directly provide his/her written informed consent.
✕. Subject with a type 3 aortic arch will be excluded from the study.
✕. Subject is or has been treated with radiation therapy to the neck or chest.
✕. Subject has a life-threatening allergy to contrast media (unless treatment for allergy can be tolerated).
✕. Subject has a known cardiac disorder, likely to be associated with cardio-embolic symptoms such as atrial fibrillation (AFib).
What they're measuring
1
The cumulative incidence of all adverse events (serious and non-serious)
✕. Subject has any condition, which in the opinion of the treating physician, would place the subject at a high risk of embolic stroke.
✕. Subject is unable to complete the required follow-up.
✕. Subject is pregnant or breastfeeding. (Females of childbearing potential who are less than 45 years old must have a pregnancy test and provide written proof that they are not pregnant prior to inclusion.)