Intracranial giant aneurysm
Conditions
Interventions
No addtional interventions are required as compared to the standard ELANA
procedure. All intervention steps are equal. The only difference is that
instead of the ELANA ring now the slide design will
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patient is 18 or more years old on the date he/she signed the informed consent ;Patient requires a temporary or permanent ELANA bypass to be connected to one or more suitable intracranial vessel(s) for an established ELANA indication (non occlusive bypass operation) Reason for this procedure is because of a lesion not ideal for coiling or clipping or excision or temporary or permanent occlusion of a vessel without the temporary or permanent creation of a bypass From preoperative considerations it seems that the patient can provide a suitable donor graft which does not seem to be varicose, obliterated or stenosed and which can be expected to have a diameter compatible with the proximal and distal target vessel and sufficient in length to bridge the distance from the proximal to distal anastomosis;Recipient vessel has an outer diameter of at least 3mm
Exclusion criteria
Exclusion criteria: Patient cannot be without clopidogrel (Plavix®) for the surgery and through discharge Patient participates in another clinical investigation that could confound the evaluation of the Study device;Patient is allergic to Aspirin;Surgeon believes the patient is an unsuitable surgical candidate because of a poor general state of health, which would not permit the required operating and anesthesia time or because of abnormal blood coagulation values
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of this feasibility study is the technical success of positioning the SLIDE device to create a sutureless bypass to the brainvessels. A technical success is defined when the SLIDE device was used in connecting the graft to the recipient vessel without the need for vessel repair by using sutures and without any other SLIDE device related adverse events followed by a technical success of positioning the laser catheter in the graft. This will be measured by documenting the time required to position the slide and to document the need for vessel repair when the slide has been positioned. Also the angiogram at day 7 follow-up will be used to evaluate the patency of the bypass. Due to the limited size of this feasibility study no secondary endpoints will be defined. | — |
Countries
Netherlands
Outcome results
None listed