US IDE Study of the Contour NEurovasCular System™ for IntraCranial Aneurysm Repair

Ki vehet részt

• Patient is 18-75 years of age at the time of screening
• Patient has a single ruptured or unruptured IA requiring treatment. If the patient has an additional IA requiring treatment, the additional IA must not require treatment within 60 days of the index procedure
• The target IA must have the following characteristics:; Saccular morphology; Located at a bifurcation in the anterior or posterior circulation; Aneurysm neck diameter between 2 and 10 mm and aneurysm equatorial diameter between 2 and 10.5 mm; Wide-necked, defined as neck size ≥ 4 mm or a dome/neck ratio < 2
• Patient may be treated with Contour without the use of additional implanted devices
• Patient is able to comply with all aspects of the screening, evaluation, treatment, and the post-procedure follow-up schedule
• Patient or legally authorized representative has signed and dated an institutional review board (IRB)/Ethics Committee (EC)-approved written informed consent prior to initiation of any study procedures; FOR PATIENTS WITH UNRUPTURED ANEURYSM
• Patient meets the criteria outlined in the "Guidelines for the Management of Patients With Unruptured Intracranial Aneurysms" as published by the AHA/ASA FOR PATIENTS WITH RUPTURED ANEURYSM
• Patient meets the criteria outlined in the "Guidelines for the Management of Aneurysmal Subarachnoid Hemorrhage: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association" as published by the AHA/ASA
• Patient must be neurologically stable with Hunt \& Hess Score of I, II or III

Ki nem vehet részt

• Anatomy or physiology considered unsuitable for endovascular treatment with the Contour device by the implanting physician and/or the Patient Selection Committee
• Target IA contains other devices/implants (e.g., coils) that could interfere with the correct placement of the Contour device
• Anticoagulation medications (e.g., warfarin) that cannot be discontinued
• Conditions placing them at high risk for ischemic stroke or had exhibited ischemic symptoms such as transient ischemic attacks, minor strokes, or stroke-in-evolution within the prior 60-days
• modified Rankin Scale (mRS) score ≥ 2 prior to presentation or rupture (as applicable)
• Subject is enrolled in another device or drug study in which participation could confound study results
• Subject has a known, untreatable hypersensitivity to contrast dye, iodine, or any component of the treatment device
• Vascular disease or other vascular anomaly that precluded the necessary access to the aneurysm for use of the study device
• Any circulatory, neurovascular, cardiovascular, or neurologic conditions that can result in unstable neurological symptoms (e.g., multiple sclerosis, established seizure disorder)
• SAH from a non-index aneurysm or any other intracranial hemorrhage within 90 days
• Physical, neurologic or psychiatric conditions which precluded his/her ability to comply with all aspects of the screening, evaluation, treatment, and the post-procedure follow-up schedule
• Life expectancy of less than 2 years due to an illness or condition other than the index intracranial aneurysm
• Contraindication to anticoagulants or anti-platelet medications
• Acute / chronic renal failure (unless on dialysis) and/or creatinine > 2.00 mg/dl or > 182 μmol/L
• Stenosis of the target IA's parent vessel is >50%
• Clinical, angiographic or CT evidence of vasospasm, vasculitis, an intracranial tumor (except small meningioma) or any other intracranial vascular malformations on presentation
• Pregnant, breastfeeding or planning pregnancy in the next 2 years