Safety and Efficacy of Honeycomb Microporous Covered Stents (NCVC-CS1) for the Treatment of Intracranial Aneurysms

Inclusion criteria

(Provisional registration)

• Age between 20 and 75 years.
• Target lesion is an unruptured aneurysm regardless of prior treatment diagnosed by angiography, CTA, or MRA within 180 days

• Target aneurysm located in petrous/cavernous portion of internal carotid artery, intradural vertebral artery except for its union, or basilar artery below the orifice of superior cerebellar artery.
• Target aneurysm is considered difficult to treat by conventional surgical/endovascular procedures
• Target aneurysm with a sac diameter exceeding 7 mm.
• Target aneurysm with a neck diameter over 4 mm or with a ratio "dome/neck" smaller than 2.
• Modified Rankin score of 3 or less
• Agreement for participating in the study and informed consent signed by the patient.

(definitive registration)

• Target lesion must be reconfirmed by angiography or interventional procedure and is compatible with the conditions as follows:

• Target aneurysm located in petrous/cavernous portion of internal carotid artery, intradural vertebral artery except for its union, or basilar artery below the orifice of superior cerebellar artery.
• Target aneurysm is considered difficult to treat by conventional surgical/endovascular procedures
• Target aneurysm with a sac diameter exceeding 7 mm.
• Target aneurysm with a neck diameter over 4 mm or with a ratio "dome/neck" smaller than 2.
• Parent artery of target aneurysm is accessible by the investigational devices
• The diameter of the parent artery between 3.5 and 5 mm.

Exclusion criteria

(Provisional registration)

• Any invasive surgical procedure within 30 days before registration.
• Prior stent implantation at the site of target aneurysm
• Existence of intracranial tumor, arteriovenous malformation for which any intervention is considered necessary, or co-existence of unruptured intracranial aneurysm whose sac diameter over 5mm within the target vessel.
• Coexistence of other unruptured intracranial aneurysms which are planned for intervention
• Target vessel not suitable for delivery and placement of covered stent because of anatomical configuration (i.e. severe bend or tortuosity).
• More than 50% stenosis in the target vessel or its proximity including extracranial region.
• Any intracranial hemorrhage within 42 days before registration.
• Co-morbid conditions that may limit survival to less than 6 months, or difficult to observe the patient for 6 months.
• Renal dysfunction whose serum creatinine more than 2.0
• Contraindications to antiplatelet or anticoagulant treatment because of allergy or hemorrhagic diathesis.
• Platelets less than 100,000/mm3 or known dysfunction of platelets.
• Active bacterial infection.
• Any cardiac, hematological, intracranial, or vessel disease which are considered to have high risk of neurological events (severe cardiac failure, atrial fibrillation, arteritis, known carotid artery stenosis, etc.).
• History of severe allergy to contrast dye.
• Known allergy to cobalt-chromium alloy and polyurethane. clopidogrel, heparin, nitinol, local or general anesthesia
• Subjects who have enrolled, or are planned to participate in other clinical trial or intervention study.
• Pregnant woman
• Unsuitable patients judged by the physician attending this trial.

(definitive registration)

• History of any invasive surgical procedure after the provisional registration.
• Any new neurological signs within 24 hours prior to the procedure.