Intracranial giant aneurysm
Conditions
Interventions
This is a pilot study and the intervention is exactly the same as that for the
standard Elana technique. However instead of using a ring (that requires
suturing) now the Clip device (sutureless) wil
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patient is > 18 years old on the date he/she signed the informed consent ;Patient requires a temporary or permanent bypass in the brain as determined by the physician.;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 with sufficient length to bridge the distance from the proximal to distal anastomosis;Target vessels should have 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 (add at an appropriate safety margin - at least 50% - to the expected surgery time in the assessment) or because of abnormal blood coagulation values
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of this pilot study is the technical success of the Clip system. A technical Clip system success is defined as follows: 1.The Clip has been used for graft to the recipient or donor vessel connection, without the need for any sutures and/or significant bleeding. 2. The laser catheter retrieved a tissue flap and after creation of the artheriotomy the connection area does not show significant bleeding that requires additional treatment. 3.No Clip system related serious adverse events are reported at the time the patient is leaving the OR | — |
Secondary
| Measure | Time frame |
|---|---|
| Due to the limited size of this pilot study no secondary endpoints will be defined. However basic information will be collected about: • Creation of functional arteriotomy • Total duration of surgery • Need to use anticoagulation medication • 7 days angiogram to verify patency (part of standard Elana procedure, so this is not an extra evaluation) | — |
Countries
Netherlands
Outcome results
None listed