The objective of this pilot study is to investigate the feasibility of using the Clip system in a human setting in creating an intracranial arteriotomy in a non-occlusive, sutureless fashion. Although the focus is on the technical success of the…
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 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 outcome
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)
Background summary
In 2010 a pilot study was performed using the Elana Slide design. The
breakthrough of this concept is that no sutures are required to create a
connection between donor and recipient vessels (anastomosis). The huge
advantage is that no sutures are required on vessels that run deep in the
brain. To do this, space is required, which is barely available.Because of
that, creating a suture in on vessels in the skull are very intensive and time
consuming. With the Slide device, that requires no sutures, total operation
time could be reduced and also even deeper structures (that are impossible to
suture) could be reached.The slide pilot study was performed under protocol
number NL32154.041.10. During this phase it appeared that the device was not
optimal for further clinical use. Especially there was too much friction during
the insertion into the recipient vessel and the visibility of positioning was
limited. So a visual inspection during the operation was difficult.
The new Clip design overcomes the disadvantages of the Slide and has been
tested extensively in vitro and in vivo (both rabbits and pigs). The results
are very good and due to that the step towards a new human pilot study is
justified. It will be a single site, single physican set up. The study set-up
will be totally comparable to the previous Slide study.
Study objective
The objective of this pilot study is to investigate the feasibility of using
the Clip system in a human setting in creating an intracranial arteriotomy in a
non-occlusive, sutureless fashion. Although the focus is on the technical
success of the design, at the same time the clinical success and the safety
will be followed for 30 days to evaluate that no unexpected device related
events occur
Study design
This is a pilot study. One surgeon within UMC Utrecht will perform all
procedures. A maximum of 5 patients or a minimum of 5 device uses are targeted.
(Note: in a patient both proximal and distal anastomoses could be created using
the device)
Intervention
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) will be used.
Study burden and risks
By standard medical evaluation of a patient, outside any protocol, the
physician will know if a patient requires an intracranial bypass operation and
whether the ELANA procedure is indicated. When this is known, the patient will
be asked to participate in this study. The whole medical treatment plan for the
patient is not different and does not require any additional measures as
compared to the standard ELANA procedure. So, as compared to the standard
treatment there is no additional burden or risk for the patient.
Heidelberglaan 100 kamer D03 252
Utrecht 3584 CX
NL
Heidelberglaan 100 kamer D03 252
Utrecht 3584 CX
NL
Listed location countries
Age
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
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
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 | NL45868.041.13 |