Surpass Intracranial Aneurysm Embolization System Pivotal Trial to Treat Large or Giant Wide-Neck Aneurysms - SCENT: 3-year outcomes.

Background: To report the 3-year safety and effectiveness of the Surpass Streamline flow diverter in the SCENT trial (Surpass Intracranial Aneurysm Embolization System Pivotal Trial to Treat Large or Giant Wide-Neck Aneurysms).
Methods: The Surpass Streamline flow diverter device was evaluated in a multicenter, prospective, single-arm, non-randomized interventional trial including patients with uncoilable or previously treated but failed aneurysms of the intracranial internal carotid artery. 3-year outcomes were tabulated with descriptive statistics and compared with 1-year outcomes.
Results: Of 180 patients in the modified intent-to-treat (mITT) cohort, 36-month clinical and angiographic follow-up was available in 134 and 117 cases, respectively. Effectiveness endpoint of complete aneurysm occlusion without clinically significant stenosis or retreatment was met in 71.8% (79/110, 95% CI 62.4% to 80.0%) of cases. Safety composite endpoint was 12.2% (22/180) over the 3-year period, with two major safety events (ipsilateral ischemic strokes) occurring between 12-36 months. Complete aneurysm occlusion was noted in 77.8% (91/117), and 99.1% (116/117) of the patients demonstrated adequate aneurysm occlusion (complete occlusion or neck residual). There were four cases (2.2%) of aneurysm rupture, all occurring within the first month of the index procedure. Target aneurysm retreatment rate was 2.8% (5/180).
Conclusion: The present findings support the long-term safety and effectiveness of the Surpass Streamline flow diverter device.
Trial Registration: NCT01716117.
Competing Interests: Competing interests: RAH is a consultant for Stryker, Medtronic, Cerenovous, Microvention, Balt, Phenox, Rapid Medical, and Q’Apel. He is on the advisory board for MiVI, eLum, Three Rivers, Shape Medical, and Corindus. Unrestricted research grant from NIH, Interline Endowment, Microvention, Stryker, CNX. Investor/stockholder for InNeuroCo, Cerebrotech, eLum, Endostream, Three Rivers Medical Inc, Scientia, RIST, BlinkTBI, and Corindus. GMC has no disclosures to report. ALC serves as a consultant for Stryker, Medtronic, Microvention, InNeuroCo, Rapid Medical, Q’Apel, Imperative Care, and AVAIL Medsystems. PTK serves as a consultant for Stryker, Imperative Care, Cerenovus, and Microvention; research grant from NIH, Siemens, Joe Niekro, and Medtronic; Journal of NeuroInterventional Surgery editorial board. PT serves as a consultant for Stryker, Cerenovus, and Medtronic. AKW has research grants from Philips Medical, fellowship grant from Medtronic; serves as a consultant for Stryker, Phenox, and Cerenovus JNJ; is a stockholder of InNeuroCo, EpiEP, Neural Analytics, RISt, Analytics 4 Life, and ThrombX; and is on the Speakers’ Bureau for SCENT trial (Surpass Intracranial Aneurysm Embolization System Pivotal Trial to Treat Large or Giant Wide Neck Aneurysms) presentations. BGW served as a consultant/proctor for Stryker and is the past Chair of AANS/CNS Cerebrovascular section. AD has no disclosures to report. MDB serves as a consultant for Stryker and was on the hemorrhagic advisory board for Stryker. JDV serves as a consultant for Stryker Neurovascular and Evasc Ltd and was part of the screening committee French EESIS study (Evasc). KE serves as a consultant for Stryker and Microvention and was a member of the Cerebrovascular Section Joint Guidelines Review Committee. PMM serves as a consultant for Stryker, Medtronic, and Penumbra.
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