The primary endpoint of this feasibility study is the technical success of positioning the SLIDE device to verify the speed and ease of use without unexpected device related adverse events. A technical success is defined that the SLIDE device was…
ID
Source
Brief title
Condition
- Nervous system, skull and spine therapeutic procedures
- Aneurysms and artery dissections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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.
Secondary outcome
not applicable
Background summary
In brief the following findings can be reported as background of the SLIDE
research. In a series of 42 rabbits, using the aorta as recipient artery and
human saphenous vein as graft, 90 standard ELANA anastomosis were compared to
90 SLIDE anastomosis and the results indicated that in these acute experiments
the SLIDE anastomosis was at least as good as with the standard ELANA
technique. Hereafter 28 ELANA anastomis were compared to 28 SLIDE design in a
pressurized human cadaver model to mimic the human situation. These results
clearly indicated that the SLIDE design was easier to apply as compared to the
standard ELANA procedure. These experiments were so convincing that a long term
in vivo experiment was set up with in total 38 pigs to show patency, flow and
endothelalization in the anastomosis when the the SLIDE design was used.
Results indicated that complete endothelialization was observed after 3 weeks
and that the flow was equal if not better as known from historical ELANA data.
When the SLIDE design was used the mean flow was 160+ 56 ml/min while for ELANA
procedure this was 145+29 ml/min. On long term follow up (6 months) no
complications were observed and the anastomosis was patent with full
endothelization. These experiments clearly showed that the SLIDE design is at
least as good as the current ELANA procedure but with the big expected
advantage of being faster, easier and more likely to reach deeper structures
and for that reason is ready to be used in a human setting.
Study objective
The primary endpoint of this feasibility study is the technical success of
positioning the SLIDE device to verify the speed and ease of use without
unexpected device related adverse events. A technical success is defined that
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. Also the angiogram at day 7 follow-up will be
used to evaluate the patency of the bypass.
Study design
This study is a nonrandomized, single-center, physician sponsored pilot study
is to confirm the feasibility of using the SLIDE design in a human setting in
creating an intracranial arteriotomy in a non-occlusive, sutureless manner.
Intervention
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 be used to create the
anastomosis.
Study burden and risks
Risks:
The risk in relation to the SLIDE design are very limited. Instead of sutures
now special pins are used to connect the graft to the recipient vessel. It
could be that leakage occurs after positioning the Slide in the recipient
vessel but tissue sealant will be used to manage this type of leakage. If too
much force is used, or if the vessel condition is really poor, there might be a
risk of vessel damage when inserting the Slide in the recipient wall. This risk
is not anticipated to be higher than if sutures would be used.
Benefits:
By using the SLIDE design an anastomosis can be created in the depth of the
brains because no sutures are required anymore to create the anastomosis. For
this reason also the deeper structures might be reached and more patients could
benefit from this bypass technique with less risks of damaging brain
structures. Also the Slide design will possibly lead to quicker procedure times
(2-4 hours quicker) because the time consuming suturing steps can be omitted.
The benefits associated with the use of the SLIDE design in the Elana
Arteriotomy System outweigh the risks and for this reason can be used in a
clinical setting.
Heidelberglaan 100
3584 CX Utrecht
NL
Heidelberglaan 100
3584 CX Utrecht
NL
Listed location countries
Age
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
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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL32154.041.10 |