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

Collaborators, Affiliations

Collaborators

SCENT Investigator Group:
A Coon, G Colby, Justin Caplan, Li-Mei Lin, P Kan, M Mokin, Zinovy Katz, A Dogan, S Barnwell, R Priest, H Bozorgchami, W Clark, B Petersen, G Nesbit, H Lutsep, S Ford, Noah Beadell, Jeremy Fields, Kory Herrick, David Hoak, Scott Rewinkel, Andrew Rontal, Stewart Weber, B Welch, G L Pride, Kim Dutton-Johnson, Nikhil Mehta, M Bain, G Toth, J DeVries, H Boogaarts, K Ebersole, A Reeves, E J Madarang, D K Lopes, R Moftakhar, M Chen, Richard Crowley, R Moftakhar, A Puri, F Massari, G Lanzino, H Cloft, D Kallmes, P Meyers, S Lavine, G Mandigo, Daniel Sahlein, B Hoh, Spiros Blackburn, C Fox, P Jabbour, S Tjoumakaris, R Rosenwasser, Aaron Dumont, Fernando Gonzalez, K Woodward, L M Lin, S Suzuki, K Golshani, R Hanel, R Tawk, D Miller, J Mocco, M Froehler, R Hanel, E Sauvageau, P Kan, Edward Duckworth, Hesham Morsi, P Taussky, E Stevens, Min Paru, A Evans, K Liu, R Crowley, P Schweickert, L Fulks, A Walton, H Hixon, J M Gingras, P Schmitt, D Raper, Christopher Durst, Robert Starke, A Zauner, R Taylor, Samuel Hou, G Dabus, I Linfante, R Turner, M Chaudry, A Turk, A Spiotta, O Zaidat, B F Fitzsimmons, J Lynch, M Lazzaro, A Siddiqui, K Snyder, E Levy

Affiliations

¹ Lyerly Neurosurgery, Baptist Neurological Institute, Jacksonville, Florida, USA rhanel@lyerlyneuro.com.
² Lyerly Neurosurgery, Baptist Neurological Institute, Jacksonville, Florida, USA.
³ Carondelet Neurological Institute, Carondelet Saint Joseph's Hospital, Tucson, Arizona, USA.
⁴ Department of Neurosurgery, The University of Texas Medical Branch at Galveston School of Medicine, Galveston, Texas, USA.
⁵ Department of Neurosurgery, University of Utah Medical Center, Salt Lake City, Utah, USA.
⁶ Neurointerventional Radiology, Lahey Clinic Medical Center, Burlington, Massachusetts, USA.
⁷ Neurosurgery, The University of Texas Southwestern Medical Center, Dallas, Texas, USA.
⁸ Interventional Neuroradiology, Oregon Health & Science University, Portland, Oregon, USA.
⁹ Neurosurgery, Cleveland Clinic, Cleveland, Ohio, USA.
¹⁰ Neurosurgery, Radboud University Nijmegen, Nijmegen, Gelderland, The Netherlands.
¹¹ Neurosurgery, Radiology, University of Kansas Medical Center Department of Neurosurgery, Kansas City, Kansas, USA.
¹² Radiology and Neurological Surgery, Columbia University, New York, New York, USA.

PMID: 36375835
DOI: 10.1136/jnis-2022-019512

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

Ricardo A Hanel et al. J Neurointerv Surg. 2023 Nov.

. 2023 Nov;15(11):1084-1089.

doi: 10.1136/jnis-2022-019512. Epub 2022 Nov 14.

Authors

Collaborators

SCENT Investigator Group:
A Coon, G Colby, Justin Caplan, Li-Mei Lin, P Kan, M Mokin, Zinovy Katz, A Dogan, S Barnwell, R Priest, H Bozorgchami, W Clark, B Petersen, G Nesbit, H Lutsep, S Ford, Noah Beadell, Jeremy Fields, Kory Herrick, David Hoak, Scott Rewinkel, Andrew Rontal, Stewart Weber, B Welch, G L Pride, Kim Dutton-Johnson, Nikhil Mehta, M Bain, G Toth, J DeVries, H Boogaarts, K Ebersole, A Reeves, E J Madarang, D K Lopes, R Moftakhar, M Chen, Richard Crowley, R Moftakhar, A Puri, F Massari, G Lanzino, H Cloft, D Kallmes, P Meyers, S Lavine, G Mandigo, Daniel Sahlein, B Hoh, Spiros Blackburn, C Fox, P Jabbour, S Tjoumakaris, R Rosenwasser, Aaron Dumont, Fernando Gonzalez, K Woodward, L M Lin, S Suzuki, K Golshani, R Hanel, R Tawk, D Miller, J Mocco, M Froehler, R Hanel, E Sauvageau, P Kan, Edward Duckworth, Hesham Morsi, P Taussky, E Stevens, Min Paru, A Evans, K Liu, R Crowley, P Schweickert, L Fulks, A Walton, H Hixon, J M Gingras, P Schmitt, D Raper, Christopher Durst, Robert Starke, A Zauner, R Taylor, Samuel Hou, G Dabus, I Linfante, R Turner, M Chaudry, A Turk, A Spiotta, O Zaidat, B F Fitzsimmons, J Lynch, M Lazzaro, A Siddiqui, K Snyder, E Levy

Affiliations

¹ Lyerly Neurosurgery, Baptist Neurological Institute, Jacksonville, Florida, USA rhanel@lyerlyneuro.com.
² Lyerly Neurosurgery, Baptist Neurological Institute, Jacksonville, Florida, USA.
³ Carondelet Neurological Institute, Carondelet Saint Joseph's Hospital, Tucson, Arizona, USA.
⁴ Department of Neurosurgery, The University of Texas Medical Branch at Galveston School of Medicine, Galveston, Texas, USA.
⁵ Department of Neurosurgery, University of Utah Medical Center, Salt Lake City, Utah, USA.
⁶ Neurointerventional Radiology, Lahey Clinic Medical Center, Burlington, Massachusetts, USA.
⁷ Neurosurgery, The University of Texas Southwestern Medical Center, Dallas, Texas, USA.
⁸ Interventional Neuroradiology, Oregon Health & Science University, Portland, Oregon, USA.
⁹ Neurosurgery, Cleveland Clinic, Cleveland, Ohio, USA.
¹⁰ Neurosurgery, Radboud University Nijmegen, Nijmegen, Gelderland, The Netherlands.
¹¹ Neurosurgery, Radiology, University of Kansas Medical Center Department of Neurosurgery, Kansas City, Kansas, USA.
¹² Radiology and Neurological Surgery, Columbia University, New York, New York, USA.

PMID: 36375835
DOI: 10.1136/jnis-2022-019512

Abstract

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.

Keywords: Aneurysm; Flow Diverter; Technology.

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Conflict of interest statement

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

Collaborators

Affiliations

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

Authors

Collaborators

Affiliations

Abstract

Conflict of interest statement

Associated data

LinkOut - more resources

Full Text Sources

Medical

Miscellaneous