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.
- Flow Diverter
Data availability statement
Data are available upon reasonable request.
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RAH and GMC are joint first authors.
Twitter @dralexandercoon, @PeterKa80460001
Collaborators SCENT Investigator Group (sorted by number of patients recruited):John Hopkins University (25) – A Coon (Past PI), G Colby (Past PI), Justin Caplan (Current PI) (did not treat patients but is current PI); Li-Mei Lin (Sub-I)Tampa General Hospital (16) - P Kan (PI), M Mokin (PI) (did not treat patients but is current PI); Zinovy Katz (Sub-I) Oregon Health and Science University (14) - A Dogan (PI and Past Sub-I), S Barnwell (Past PI), R Priest (Past PI and Current Sub-I), H Bozorgchami (Sub-I), W Clark (Sub-I); B Petersen (Sub-I); G Nesbit (Sub-I); H Lutsep (Sub-I); S Ford (Sub-I); Noah Beadell (Sub-I); Jeremy Fields (Sub-I); Kory Herrick (Sub-I); David Hoak (Sub-I); Scott Rewinkel (Sub-I); Andrew Rontal (Sub-I); Stewart Weber (Sub-I); University of Texas – Southwestern (11) - B Welch (PI), GL Pride (Sub-I); Kim Dutton-Johnson (Sub-I); Nikhil Mehta (PI); Cleveland Clinic (11) - M Bain (PI), G Toth (Sub-I) UMC St Radboud (The Netherlands) (10) – J DeVries (PI), H Boogaarts (Sub-I); University of Kansas Medical Center (10) - K Ebersole (PI), A Reeves (Sub-I), EJ Madarang (Sub-I) Rush University Medical Center (8) - DK Lopes (Past PI), R Moftakhar (Sub-I); M Chen (Current PI and Past Sub-I); Richard Crowley (Sub-I); R Moftakhar (Sub-I); University of Massachusetts Medical School (8) - A Puri (PI), F Massari (Sub-I); (7) - G Lanzino (PI), H Cloft (Sub-I); D Kallmes (Sub-I); Columbia University (7) - P Meyers (PI), S Lavine (Sub-I); G Mandigo (Sub-I); Daniel Sahlein (Past Sub-I); University of Florida – Gainesville (6) - B Hoh (Past PI and Current Sub-I), Spiros Blackburn, MD (Past PI), C Fox (Current PI did not treat patients but is the current PI); Thomas Jefferson University (6) - P Jabbour (PI), S Tjoumakaris (Sub-I); R Rosenwasser (Sub-I); Aaron Dumont (Sub-I); Fernando Gonzalez (Sub-I); Fort Sanders Regional Medical Center (6) - K Woodward (PI); University of California – Irvine (6) - LM Lin (PI), S Suzuki (Sub-I); K Golshani (Sub-I); Mayo Clinic – Florida (5) – R Hanel (past PI), R Tawk (PI and Past Sub-I); D Miller (Sub-I); Vanderbilt University Medical Center (4) – J Mocco (past PI), M Froehler (PI did not treat patients but is current PI), Lyerly Neurosurgery (4) - R Hanel (PI), E Sauvageau (Sub-I); Baylor College of Medicine (4) - P Kan (PI); Edward Duckworth (Sub-I); Hesham Morsi (Sub-I); University of Utah (3) - P Taussky (PI), E Stevens (Sub-I); Min Paru (Sub-I); University of Virginia (3) - A Evans (PI did not treat patients), K Liu (past PI) (Sub-I); R Crowley (Sub-I); P Schweickert (Sub-I); L Fulks (Sub-I); A Walton (Sub-I); H Hixon (Sub-I); JM Gingras (Sub-I); P Schmitt (Sub-I); D Raper (Sub-I); Christopher Durst (Sub-I); Robert Starke (Sub-I); Santa Barbara Cottage Hospital (2) - A Zauner (PI), R Taylor(Sub-I); Samuel Hou (Sub-I); Baptist Hospital of Miami (1) - G Dabus (PI); I Linfante (Sub-I); Medical University of South Carolina (1) - R Turner (Current PI Resigning Nov 30), M Chaudry(Sub-I); A Turk (Sub-I); A Spiotta (Current Sub-I. PI beginning Nov 30. Waiting on IRB Approval from Site) Medical College of Wisconsin Froedtert Hospital (1) – O Zaidat (Past PI), BF Fitzsimmons (Current PI Past Sub-I did not treat patients but is current PI), J Lynch (Sub-I); M Lazzaro (Sub-I); University of Buffalo (1) – A Siddiqui (PI), K Snyder (Sub-I); E Levy (Sub-I).
Contributors RAH and GMC drafted the initial manuscript and are joint first authors. All authors were involved and made substantial contributions to the conception or design of the work, or the acquisition, analysis, or interpretation of the data; revising it critically for important intellectual content; final approval of the version published; and agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. RAH is responsible for the overall content as the guarantor.
Funding This study was sponsored by Stryker. The sponsor of the study was responsible for site management, data management and monitoring, safety reporting, and statistical analysis. An academic steering committee supervised trial design and operations. A publication committee comprised of the academic steering committee and academic principal investigators who enrolled most patients interpreted the results and wrote the report. The corresponding author had full access to all the data and had final responsibility for the decision to submit for publication. SCENT (Surpass Intracranial Aneurysm Embolization System Pivotal Trial to Treat Large or Giant Wide Neck Aneurysms) is registered with ClinicalTrials.gov (URL: https://www.clinicaltrials.gov Unique identifier: NCT01716117).
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.
Provenance and peer review Not commissioned; externally peer reviewed.
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