The purpose of this study is to evaluate safety and performance of the Surpass Aneurysm-Embolization System.
ID
Source
Brief title
Condition
- Vascular therapeutic procedures
- Aneurysms and artery dissections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The adverse events assessment for all enrolled subjects in the study includes:
•Incidence of adverse events assessed during the procedure, immediately
post-procedure through discharge.
The adverse event assessment for all subjects with a deployed device includes:
•Incidence of adverse events assessed during the procedure, immediately
post-procedure, at discharge, at thirty days and six months after treatment.
The neurological status for all subjects with a deployed device includes:
•Clinical/neurological outcome using neurological evaluations (NIH Stroke
Scale, Modified Rankin Scale) by qualified personnel after the procedure, at
thirty days and six months after treatment compared to the baseline evaluation.
The technical feasibility for all subjects with a deployed device includes:
•Evaluation of percent occlusion assessed at six months after treatment.
•Successful stent placement (device success defined as device placed where
intended with appropriate wall apposition) angiographically assessed
immediately post-procedure.
Secondary outcome
none
Background summary
Aneurysms are a challenge to treat both surgically and endovascularly. During
surgical clipping, a section of the skull is removed in order to create a hole
to see the aneurysm. A small metal clip is then placed around the neck of the
aneurysm, blocking any blood from entering. This treatment is associated with
a high incidence of morbidity and mortality. Surgical clipping may be difficult
or impossible depending on the aneurysm*s location in the brain or if there is
no true neck (opening) of the aneurysm present.
Endovascular therapy has been limited to parent artery occlusion (if there is
adequate collateral flow), or treatment with embolic coils (small metal coils),
with or without the use of balloon dilatation and/or stent implantation.
Balloon dilatation, however, has limitations because the temporary interruption
of blood flow in the parent artery increases the risk of local and distal
thromboembolism. Furthermore, balloon dilatation is not applicable in wide-neck
or complex aneurysms, and its long-term efficacy has not been proven. Aneurysms
may be difficult to treat with embolic coils alone because of the significant
risk of coil prolapse into the parent artery.
The goal of endovascular treatment is complete thrombosis of the aneurysm while
preserving the parent and side-branch artery lumen. Endovascular coiling has a
much lower mortality and morbidity rate than surgery, however, large and giant
aneurysms are associated with over 40% of relapse necessitating re-treatment of
the patient.
The device under investigation has a big advantage over surgery or coiling:
with the use of the Surpass Aneurysm-Embolisation System there is no need for
placement of coils, resulting in a decrease in procedure time and cost. In
addition, risk of relapse after treatment of the aneurysm with the Surpass
Aneurysm-Embolisation System is estimated to be < 5% (animal study showed > 97%
aneurysm occlusion over a period of six months) while maintaining the lower
mortality / morbidity rate of coiling.
Study objective
The purpose of this study is to evaluate safety and performance of the Surpass
Aneurysm-Embolization System.
Study design
This is a single-center, prospective, non-randomized study including up to 10
subjects treated with the device. Subjects will receive a follow-up evaluation
at thirty days (+ two weeks) and at six months (± four weeks) with a follow-up
angiography at six months.
Intervention
Treatment with the Surpass Aneurysm-Embolization System
Study burden and risks
The study is designed to minimize potential risks and complications in the
subjects. Risks associated with using the Surpass Aneurysm-Embolization System
are believed to be the same as those associated with intracranial
catheterization or intracranial stent placement. The following complications
associated with intracranial catheterization or intracranial stent placement
have been identified as possible (anticipated) complications and may occur:
•Aneurysm recanalization
•Allergic reaction including, but not limited to, contrast, and medications
•Arrhythmia
•Arteriovenous fistula
•Death
•Dissection
•Emboli (air, tissue or thrombotic emboli)
•Emergent neurosurgery
•Failure to deliver the device to the intended site
•Hemorrhage
•Hematoma
•Hypotension / Hypertension
•Incomplete Aneurysm Occlusion
•Infection
•Injury to normal vessels or tissue
•Ischemia
•Occlusion of side branch
•Myocardial infarction
•Neurologic deficit
•Pain at insertion site
•Perforation
•Pseudoaneurysm
•Renal failure
•Rupture, vessel or aneurysm
•Seizures
•Stenosis of treated segment
•Device migration / embolization
•Device thrombosis / occlusion
•Stroke / cerebrovascular accident
•Total occlusion of treated segment
•Vasospasm
•Vessel thrombosis
14 Mintz Street
69512 Tel Aviv
IL
14 Mintz Street
69512 Tel Aviv
IL
Listed location countries
Age
Inclusion criteria
•Subject understands the nature of the procedure and provides written informed consent.
•Subject is willing to return to the investigational site for the thirty day and six month follow-up evaluations.
•Age 18 years to 80 years.
•Subject with a non-ruptured saccular, dissecting or fusiform intracranial aneurysm arising from a parent vessel with a diameter of >= 2mm and <= 6mm.
Exclusion criteria
•Pregnancy and lactating women
•Participation in another investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this study
•Allergy or contraindication to aspirin, clopidogrel, heparin, local or general anesthesia
•History of life threatening allergy to contrast dye.
•Major surgery within previous 30 days or planned in the next 90 days after enrollment date.
•Dementia or psychiatric problem that prevents the patient from completing required follow up
•Co-morbid conditions that may limit survival to less than one year
•Subject with anatomy not appropriate for endovascular treatement due to severe intracranial vessel tortuosity or stenosis, or intracranial vasospasm not responsive to medical therapy.
•Subject with an intracranial mass (tumor (except meningioma), abscess, or other infection), or is undergoing radiation therapy for carcinoma or sarcoma of the head or neck region.
•Subject has a history of bleeding diathesis or coagulopathy, international normalized ratio (INR) greater than 1.5, or will refuse blood transfusions.
•Subject has a serum creatinine level greater than 2.0 mg/dL (within 7 days of procedure) which the investigator determines restricts the use of contrast agents.
•Subject has a previously implanted intracranial stent associated with the symptomatic distribution within the past 12 weeks prior to enrollment date
•Stenting, angioplasty, or endarterectomy of an extracranial (carotid or vertebral artery) or intracranial artery within 30 days prior to enrollment date
•Subject has a previously implanted carotid stent associated with the symptomatic distribution within the past 12 weeks prior to enrollment date
•Subject has uncontrolled atrial fibrillation or known cardiac disorders likely to be associated with cardioembolic symptoms.
•Subject had a subarachnoid hemorrhage within 12 weeks prior to the enrollment date.
•Subject with resistance to ASA and/or Clopidogrel.
•Subject with two or more aneurysms in associated distribution - unless the device is used to treat both aneurysms.
•Subject has a non-treated arteriovenous malformation (AVM) in the territory of the target aneurysm.
•Target aneurysm is expected to require more than one device.
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 | NL28760.091.09 |