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Clinical Trial
Results of the ANSWER Trial Using the PulseRider for the Treatment of Broad-Necked, Bifurcation Aneurysms.
- Alejandro M Spiotta, Colin P Derdeyn, Satoshi Tateshima, Jay Mocco, R Webster Crowley, Kenneth C Liu, Lee Jensen, Koji Ebersole, Alan Reeves, Demetrius K Lopes, Ricardo A Hanel, Eric Sauvageau, Gary Duckwiler, Adnan Siddiqui, Elad Levy, Ajit Puri, Lee Pride, Roberta Novakovic, M Imran Chaudry, Raymond D Turner, and Aquilla S Turk.
- Department of Neurosurgery, Medical University of South Carolina, Charleston, South Carolina.
- Neurosurgery. 2017 Jul 1; 81 (1): 56-65.
BackgroundThe safety and probable benefit of the PulseRider (Pulsar Vascular, Los Gatos, California) for the treatment of broad-necked, bifurcation aneurysms was studied in the context of the prospective, nonrandomized, single arm clinical trial-the Adjunctive Neurovascular Support of Wide-neck aneurysm Embolization and Reconstruction (ANSWER) Trial.ObjectiveTo present the results of the United States cases employing the PulseRider device as part of the ANSWER clinical trial.MethodsAneurysms treated with the PulseRider device among sites enrolling in the ANSWER trial were prospectively studied and the results are summarized. Aneurysms arising at either the carotid terminus or basilar apex that were relatively broad necked were considered candidates for inclusion into the ANSWER study.ResultsThirty-four patients were enrolled (29 female and 5 male) with a mean age of 60.9 years (27 basilar apex and 7 carotid terminus). Mean aneurysm height ranged from 2.4 to 15.9 mm with a mean neck size of 5.2 mm (range 2.3-11.6 mm). In all patients, the device was delivered and deployed. Immediate Raymond I or II occlusion was achieved in 82.4% and progressed to 87.9% at 6-month follow-up. A modified Rankin Score of 2 or less was seen in 94% of patients at 6 months.ConclusionThe results from the ANSWER trial demonstrate that the PulseRider device is safe and offers probable benefit as for the treatment of bifurcation aneurysms arising at the basilar apex or carotid terminus. As such, it represents a useful addition to the armamentarium of the neuroendovascular specialist.Copyright © 2017 by the Congress of Neurological Surgeons
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