Last updated on November 2017

Aneurysm


Brief description of study

The PulseRider® Aneurysm Neck Reconstruction Device (ANRD) is a self-expanding nitinol implant designed to retain embolic coils at a vessel bifurcation. PulseRider® is comprised of the torque device, delivery wire, introducer, and implant. (Figure 1). The implant is provided attached to the delivery wire. The PulseRider system is intended to be used with commercially available detachment power supplies (not shown) and microcatheters (not shown) with minimum inner diameter of 0.53 mm (0.021”). The torque device provided may be attached to the proximal end of the delivery wire to aid in orienting the implant prior to detachment. All the PulseRider® components are packaged in a sealed pouch and are provided sterile. PulseRider® is available in T and Y shapes with 8 mm and 10 mm wide arches. The anchor base is available in sizes to treat parent arteries from 2.7 mm to 4.5 mm. Depending on the size of the aneurysm neck and parent vessel, the appropriate size PulseRider® implant must be chosen to ensure adequate stability and anatomical fit. Note: The optimal treatment for unruptured cerebral aneurysm is not specific due to many variables and concern related to subarachnoid hemorrhage (SAH), a life-threatening event. To ensure that the probable benefits outweigh the risk of treatment, in addition to the size of the aneurysm, other risk factors should be considered, e.g., morphology, hemodynamic characteristics, patient age, family history, prior SAH, and general medical history.

Eligibility Criteria:

Patients ≥ 18 years of age with angiographically documented wide-neck, intracranial, unruptured aneurysms, originating on or near a vessel bifurcation of the basilar tip or carotid terminus, who are deemed by the attending neurointerventionalist to be acceptable candidates for endovascular embolization. The PulseRider® Aneurysm Neck Reconstruction Device (ANRD) has not been studied in women who are pregnant or lactating. A brain aneurysm is a weakening in the wall of an artery in the brain, causing the affected area to stretch out like a balloon. A wide-neck aneurysm is one that has a wide opening where the aneurysm arises from the artery. Wide-neck aneurysms have a neck width greater than or equal to 4mm or a dome-to-neck ratio of less than 2.1,2 These types of aneurysms occur in about 25% of persons with brain aneurysms.3 Wide-neck aneurysms are difficult to treat both surgically and endovascularly.The PulseRider® Aneurysm Neck Reconstruction Device (ANRD) is authorized by Federal Law for use with embolic coils for the treatment of wide-neck, intracranial, unruptured aneurysms, with neck widths of ≥ 4 mm or dome to neck ratio < 2 originating on or near a vessel bifurcation of the basilar tip or carotid terminus with at least a portion of the aneurysm neck overlapping the lumen of the parent artery. The inflow vessels should have diameters from 2.7 mm to 4.5 mm. The effectiveness of this device for this use has not been demonstrated. Using a neck bridge to support coils has been shown to improve endovascular treatment for bifurcation aneurysms.

Clinical Study Identifier: TX133519

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Sara Renfrow

Baptist Health Clinical Research Center & Lexington Cardiac Research Foundation
Lexington, KY USA
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