The patients with wide neck and/or large/giant cerebral aneurysms that are difficult to be treated by conventional surgical (clipping or carotid artery bypass) or endovascular procedures (Coil embolization alone).
Conditions
Interventions
Intervention type:DEVICE
Name of intervention:Treatment plan, Stent implantation
Dose form / Japanese Medical Device Nomenclature:DEVICE
VRD (Vascular Reconstruction Device) to facilitate endovascular
Sponsors
PEN001 Clinical Trial Office
The Jikei University Hospital, Tokyo Medical and Dental University Hospital, Dokkyo Medical University Koshigaya Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Unruptured wide-neck (neck of 4mm or more or a dome-to-neck ratio of less than 2) intracranial aneurysm with a sac diameter of 5mm or more diagnosed by angiography or CT angiography or MR angiography 1 year prior to informed consent.2) The parent vessel is with a diameter within a range from 2 to 5 mm.3) The aneurysm is difficult to be treated by conventional surgical (clipping or carotid artery bypass) or endovascular procedure (Coil embolization alone).4) Subject is aged between 20 and 80. 5) Subject is willing and able to provide informed consent. 6) Subject is willing and able to comply with protocol follow-up requirements.
Exclusion criteria
Exclusion criteria: 1)Prior ruptured aneurysms. 2)Prior deployment of the other VRD into the cervical or intracranial lesions 4 weeks prior to the study treatment. 3)Multiple aneurysms of 10mm or more. 4)Target aneurysm neck of 22mm or more.5)Target aneurysm is potentially inaccessible for the study device with anatomical or procedural reasons or due to severe vasospasm that is inefficient to pharmacological treatment. 6)Patient with bleeding disorders 7)Patient with contraindication of anticoagulation therapy. 8)Patient with cardiac diseases caused to cardiogenic cerebral embolism (atrial fibrillation, artificial heart valve, AMI within 6 weeks prior to the study treatment, mitral valve stenosis, intracardiac coagulation, bacterial endocarditis, ventricular aneurysm).9)Patient with severe heart failure (Class IV) based on the NYHA classification guidelines. 10)Patient taking warfarin for cardiac disease treatment.11)Patient with long term treatment of steroid hormone (Ointment cream, eyedrop and etc. for skin diseases and steroid for asthma are acceptable).12)Patient with kidney failure (Serum creatinine level of 2.0mg/dL or more).13)Patient with contrast media reactions in past. 14)Patient with allergy to cobalt-chromium alloy and/or platinum.15) Patient with life expectancy of 6 months or less. 16)Pregnant women or women wishing to get pregnant during study.17)Patient with significant severe intracranial artery stenosis caused by cerebral tumors and cerebral arteriovenous malformation.18)Patient who received surgical treatment within 30 days prior to the study treatment which may affects to outcome of the study.19)Patient who enrolled to other clinical studies and/or Post Marketing Surveillance (except clinical experience study) within 6 months prior to the study treatment.20)Patient who would be ineligible in the opinion of the principle investigator and/or other investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effective ratio of procedure and the endovascular aneurysm treatment planning program success 1. Procedural success 2. Success of the endovascular aneurysm treatment planning program | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluated for the efficacy of the VRD and the endovascular aneurysm treatment planning program under angiography within 180 days post procedure. Evaluated for the safety with neurological examinations. | — |
Countries
Japan
Contacts
Public ContactNoriko Horikawa
The Jikei University Hospital
Outcome results
None listed