Pilot study Clip design A pilot study about the first use of the Elana Clip design to create intracranial anastomoses
- Conditions
- 10002363Intracranial giant aneurysm10009720
- Registration Number
- NL-OMON40251
- Lead Sponsor
- niversitair Medisch Centrum Utrecht
- Brief Summary
Trial ended prematurely
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 5
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint of this pilot study is the technical success of the Clip<br /><br>system. A technical Clip system success is defined as follows:<br /><br>1.The Clip has been used for graft to the recipient or donor vessel connection,<br /><br>without the need for any sutures and/or significant bleeding.<br /><br>2. The laser catheter retrieved a tissue flap and after creation of the<br /><br>artheriotomy the connection area does not show significant bleeding that<br /><br>requires additional treatment.<br /><br>3.No Clip system related serious adverse events are reported at the time the<br /><br>patient is leaving the OR</p><br>
- Secondary Outcome Measures
Name Time Method <p>Due to the limited size of this pilot study no secondary endpoints will be<br /><br>defined. However basic information will be collected about:<br /><br>• Creation of functional arteriotomy<br /><br>• Total duration of surgery<br /><br>• Need to use anticoagulation medication<br /><br>• 7 days angiogram to verify patency (part of standard Elana procedure, so this<br /><br>is not an extra evaluation)<br /><br></p><br>