The objective of this study is to determine the safety and effectiveness of the Surpass NeuroEndoGraft* System in the endovascular treatment of large or giant wide-necked intracranial aneurysms (IA) in internal carotid artery up to the terminus.
ID
Source
Brief title
Condition
- Aneurysms and artery dissections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary efficacy endpoint is the percent of subjects with 100% occlusion
(Raymond Class 1) without clinically significant stenosis (defined as < 50%
stenosis) of the parent artery based on core lab evaluation of the 12 month
follow up angiogram and without any subsequent treatment at the target aneurysm
at the 12 month follow up visit
Secondary outcome
The secondary safety endpoint is the percent of subjects experiencing one or
more serious adverse events (SAE) through 12 months post-index procedure within
the following categories (see definitions section of this protocol), as
adjudicated by the Clinical Events Committee (CEC).
• Proportion of subjects with new or worsening major ipsilateral stroke
• Proportion of subjects experiencing acute or subacute (<6 weeks) thrombosis
of the Surpass Implant
In addition to evaluating the secondary safety endpoint in the categories
described above, all adverse events will be reported as individual rates.
4.5.2 Efficacy
The secondary effectiveness endpoints identified below will be assessed
post-index procedure annually (at 12, 24, 36, 48, 60 months) for up to 60
months:
• Rate of aneurysm rupture
• Surpass Implant stenosis (>=50% stenosis of flow diverter)
• Parent artery occlusion at the target aneurysm location (>=50% stenosis)
• Functional status: change in the modified Rankin score compared to baseline
• Technical success: defined as the proportion of subjects in whom the Surpass
implant(s) was delivered to cover the aneurysm neck.
• Proportion of subjects with Raymond Class 1, 2 and 3 at 6 months
• Proportion of subjects with complete occlusion at 6 months
• Incidence of retreatment (with Surpass System or otherwise) at 6, 12, 24 and
up to 60 months
• Surpass Flow Diverter success: implant successfully delivered to the target
location
Background summary
Stroke is the most common life-threatening neurological disease, the third
leading cause of death in the United States, and 795,000 people suffer a new
or recurrent stroke each year. Hemorrhage is responsible for 13% of these
events and the majority of these are related to rupture of intracranial
aneurysms. The incidence of unruptured intracranial aneurysms in the general
population has been estimated to range from approximately 2% up to 6%.
The most common presentation of an intracranial aneurysm is a subarachnoid
hemorrhage (SAH) secondary to aneurysm rupture, a devastating medical
emergency, with an annual incidence in North America of approximately 12 per
100,000. In a minority of patients, aneurysms can be diagnosed before
rupturing, usually because of screening related to family history or
concomitant associated disease. In addition, an increasing number of patients
have aneurysms diagnosed as incidental findings during neuroimaging for another
indication (carotid/cerebral angiography, magnetic resonance imagining (MRI) or
computer tomography (CT)). If left untreated these aneurysms could lead to a
neurological event or death.
Study objective
The objective of this study is to determine the safety and effectiveness of the
Surpass NeuroEndoGraft* System in the endovascular treatment of large or giant
wide-necked intracranial aneurysms (IA) in internal carotid artery up to the
terminus.
Study design
The Surpass IntraCranial Aneurysm EmbolizatioN System Pivotal Trial to Treat
Large or Giant Wide Neck Aneurysms (SCENT) is a multi-center, prospective,
non-randomized trial to evaluate the safety and effectiveness of the Surpass
Flow Diverter..
The study will initially include approximately 100 subjects treated with the
Surpass Flow Diverter. Following evaluation of the first 40 subjects at 6
months, an adaptive sample size approach will set the final sample size for the
SCENT trial between 100 and 180. Those physicians that have not used the study
device in a clinical setting will complete 1-3 roll-in cases before completing
a study case, allowing for a total of 45 roll-in cases. Subjects in the roll-in
cohort are not included in the target sample of 100 to 180 treated subjects.
Subjects are considered enrolled once they sign the informed consent.
All enrolled subjects that have the study device inserted in their body,
regardless of whether or not implantation of the device takes place, will
undergo post procedure follow up evaluations at one (1) month, six (6)
months, and twelve (12) months. All subjects that have the study device
implanted will continue to be followed annually for sixty (60) months
post-procedure.
Enrolled subjects that have the pre-procedure angiogram performed but do not
have the study device enter their body will be followed for thirty days. This
subject population will be referred to as *enrolled, not treated,
angio* (ENTa). Subjects that are enrolled but exit the study before the
pre-procedure angiogram will be referred to as *enrolled, not treated, no
angio* (ENTna). Enrolled subjects that are found to not be eligible to
participate in the study after signing the consent form, will be exited from
the study at determination of ineligibility
After the completion of the 12 month follow up evaluation, Stryker will submit
a Pre-market Approval (PMA) application to FDA, which will include SCENT data
to establish the safety and efficacy of the device. All subjects enrolled in
this pivotal study will continue to be followed according to this protocol and
regular annual reports will be submitted to FDA.
This study incorporates a rigorous design that involves the use of an
independent Clinical Events Committee (CEC), an angiographic core lab and study
monitors will confirm neurological assessments, all adverse events and study
data with source documentation.
Intervention
The device is called the Surpass Flow Diverter and is intended to treat large
or giant wide neck intracranial aneurysms.
Study burden and risks
The study is designed to minimize potential risks and complications in the
subjects. Risks associated with using the Surpass Flow Diverter are believed
to be similar as those associated with intracranial catheterization or
intracranial stent placement. The following risks associated with intracranial
catheterization or intracranial stent placements have been identified as
possible (anticipated) risks and may occur:
• Aneurysm recanalization
• Aneurysm enlargement
• Allergic reaction including, but not limited to, contrast medium, metals
(cobalt chromium, platinum and tungsten) and medications
• Arrhythmia
• Arteriovenous fistula
• Confusion, coma, loss of consciousness or other change in mental status
• Death
• Detachment of a component of the system
• Device migration / embolization
• Device thrombosis / occlusion
• Emboli (air, tissue or thrombotic emboli)
• Emergent neurosurgery
• Failure to deliver the Device to the intended site
• Headache
• Hemorrhage including intracranial, vascular, peritoneal, and groin
• Hematoma
• Hypotension / hypertension
• Hydrocephalous
• Incomplete aneurysm occlusion
• Infection
• Injury to normal vessels or tissue
• Ischemia
• Mass effect
• Myocardial infarction
• Nausea
• Neurologic deficit
• Occlusion of side branch
• Pain at insertion site
• Perforation of aneurysm
• Pseudoaneurysm
• Renal failure
• Reaction due to radiation exposure
• Rupture, vessel or aneurysm
• Seizures
• Stenosis of treated segment
• Stroke / TIA / cerebrovascular accident - new or worsening of symptoms
• Total occlusion of treated segment
• Vasospasm
• Vision impairment/blindness
• Vessel dissection or perforation
• Vessel thrombosis/occlusion
• Vomiting
Possible benefits:
• Less cases of ruptures
• The ability to large and wide neck aneurysms leads to treatment with fewer
resources by the available sizes of the Surpass-tool.
Haarbeemd 33
Bavel 4854MG
NL
Haarbeemd 33
Bavel 4854MG
NL
Listed location countries
Age
Inclusion criteria
age 19-80 years
subject has a single targeted intracranial aneurysm that:
- located in the internal carotid artery distribution up to the terminus
-is able to cross with a standard 0,014"guide wire
-has a neck > 4mm or no discernible neck and an aneurysm size > 10mm
Exclusion criteria
- known allergy or contraindication to Aspirin, Clopidogrel/Plavix, heparin,local or general anesthesia.
- known history of life threathening allergy to contrast dye
- More than one intracranial aneurysm that requires treatment within 12 months
- unstable neurological deficit
- extra-cranial stenosis or parent vessel with stenosis > 50% in the area proximal to the aneurysm
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 | NL41777.091.12 |