Surpass Intracranial Aneurysm Embolization System Pivotal Trial to Treat Large or Giant Wide-Neck Aneurysms - SCENT : 3-year outcomes
© Author(s) (or their employer(s)) 2023. No commercial re-use. See rights and permissions. Published by BMJ..
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.
| Medienart: |
E-Artikel |
|---|
| Erscheinungsjahr: |
2023 |
|---|---|
| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:15 |
|---|---|
| Enthalten in: |
Journal of neurointerventional surgery - 15(2023), 11 vom: 14. Nov., Seite 1084-1089 |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Hanel, Ricardo A [VerfasserIn] |
|---|
| Links: |
|---|
| Themen: |
|---|
| Anmerkungen: |
Date Revised 12.10.2023 published: Print-Electronic ClinicalTrials.gov: NCT01716117 Citation Status Publisher |
|---|
| doi: |
10.1136/jnis-2022-019512 |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM348893078 |
|---|
| LEADER | 01000naa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM348893078 | ||
| 003 | DE-627 | ||
| 005 | 20231226041337.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 231226s2023 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1136/jnis-2022-019512 |2 doi | |
| 028 | 5 | 2 | |a pubmed24n1162.xml |
| 035 | |a (DE-627)NLM348893078 | ||
| 035 | |a (NLM)36375835 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a Hanel, Ricardo A |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Surpass Intracranial Aneurysm Embolization System Pivotal Trial to Treat Large or Giant Wide-Neck Aneurysms - SCENT |b 3-year outcomes |
| 264 | 1 | |c 2023 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Revised 12.10.2023 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a ClinicalTrials.gov: NCT01716117 | ||
| 500 | |a Citation Status Publisher | ||
| 520 | |a © Author(s) (or their employer(s)) 2023. No commercial re-use. See rights and permissions. Published by BMJ. | ||
| 520 | |a 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) | ||
| 520 | |a 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 | ||
| 520 | |a 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) | ||
| 520 | |a CONCLUSION: The present findings support the long-term safety and effectiveness of the Surpass Streamline flow diverter device | ||
| 520 | |a TRIAL REGISTRATION: NCT01716117 | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Aneurysm | |
| 650 | 4 | |a Flow Diverter | |
| 650 | 4 | |a Technology | |
| 700 | 1 | |a Cortez, Gustavo M |e verfasserin |4 aut | |
| 700 | 1 | |a Coon, Alexander L |e verfasserin |4 aut | |
| 700 | 1 | |a Kan, Peter |e verfasserin |4 aut | |
| 700 | 1 | |a Taussky, Philipp |e verfasserin |4 aut | |
| 700 | 1 | |a Wakhloo, Ajay K |e verfasserin |4 aut | |
| 700 | 1 | |a Welch, Babu G |e verfasserin |4 aut | |
| 700 | 1 | |a Dogan, Aclan |e verfasserin |4 aut | |
| 700 | 1 | |a Bain, Mark |e verfasserin |4 aut | |
| 700 | 1 | |a De Vries, Joost |e verfasserin |4 aut | |
| 700 | 1 | |a Ebersole, Koji |e verfasserin |4 aut | |
| 700 | 1 | |a Meyers, Philip M |e verfasserin |4 aut | |
| 700 | 0 | |a SCENT Investigator Group |e verfasserin |4 aut | |
| 700 | 1 | |a Coon, A |e investigator |4 oth | |
| 700 | 1 | |a Colby, G |e investigator |4 oth | |
| 700 | 1 | |a Caplan, Justin |e investigator |4 oth | |
| 700 | 1 | |a Lin, Li-Mei |e investigator |4 oth | |
| 700 | 1 | |a Kan, P |e investigator |4 oth | |
| 700 | 1 | |a Mokin, M |e investigator |4 oth | |
| 700 | 1 | |a Katz, Zinovy |e investigator |4 oth | |
| 700 | 1 | |a Dogan, A |e investigator |4 oth | |
| 700 | 1 | |a Barnwell, S |e investigator |4 oth | |
| 700 | 1 | |a Priest, R |e investigator |4 oth | |
| 700 | 1 | |a Bozorgchami, H |e investigator |4 oth | |
| 700 | 1 | |a Clark, W |e investigator |4 oth | |
| 700 | 1 | |a Petersen, B |e investigator |4 oth | |
| 700 | 1 | |a Nesbit, G |e investigator |4 oth | |
| 700 | 1 | |a Lutsep, H |e investigator |4 oth | |
| 700 | 1 | |a Ford, S |e investigator |4 oth | |
| 700 | 1 | |a Beadell, Noah |e investigator |4 oth | |
| 700 | 1 | |a Fields, Jeremy |e investigator |4 oth | |
| 700 | 1 | |a Herrick, Kory |e investigator |4 oth | |
| 700 | 1 | |a Hoak, David |e investigator |4 oth | |
| 700 | 1 | |a Rewinkel, Scott |e investigator |4 oth | |
| 700 | 1 | |a Rontal, Andrew |e investigator |4 oth | |
| 700 | 1 | |a Weber, Stewart |e investigator |4 oth | |
| 700 | 1 | |a Welch, B |e investigator |4 oth | |
| 700 | 1 | |a Pride, G L |e investigator |4 oth | |
| 700 | 1 | |a Dutton-Johnson, Kim |e investigator |4 oth | |
| 700 | 1 | |a Mehta, Nikhil |e investigator |4 oth | |
| 700 | 1 | |a Bain, M |e investigator |4 oth | |
| 700 | 1 | |a Toth, G |e investigator |4 oth | |
| 700 | 1 | |a DeVries, J |e investigator |4 oth | |
| 700 | 1 | |a Boogaarts, H |e investigator |4 oth | |
| 700 | 1 | |a Ebersole, K |e investigator |4 oth | |
| 700 | 1 | |a Reeves, A |e investigator |4 oth | |
| 700 | 1 | |a Madarang, E J |e investigator |4 oth | |
| 700 | 1 | |a Lopes, D K |e investigator |4 oth | |
| 700 | 1 | |a Moftakhar, R |e investigator |4 oth | |
| 700 | 1 | |a Chen, M |e investigator |4 oth | |
| 700 | 1 | |a Crowley, Richard |e investigator |4 oth | |
| 700 | 1 | |a Moftakhar, R |e investigator |4 oth | |
| 700 | 1 | |a Puri, A |e investigator |4 oth | |
| 700 | 1 | |a Massari, F |e investigator |4 oth | |
| 700 | 1 | |a Lanzino, G |e investigator |4 oth | |
| 700 | 1 | |a Cloft, H |e investigator |4 oth | |
| 700 | 1 | |a Kallmes, D |e investigator |4 oth | |
| 700 | 1 | |a Meyers, P |e investigator |4 oth | |
| 700 | 1 | |a Lavine, S |e investigator |4 oth | |
| 700 | 1 | |a Mandigo, G |e investigator |4 oth | |
| 700 | 1 | |a Sahlein, Daniel |e investigator |4 oth | |
| 700 | 1 | |a Hoh, B |e investigator |4 oth | |
| 700 | 1 | |a Blackburn, Spiros |e investigator |4 oth | |
| 700 | 1 | |a Fox, C |e investigator |4 oth | |
| 700 | 1 | |a Jabbour, P |e investigator |4 oth | |
| 700 | 1 | |a Tjoumakaris, S |e investigator |4 oth | |
| 700 | 1 | |a Rosenwasser, R |e investigator |4 oth | |
| 700 | 1 | |a Dumont, Aaron |e investigator |4 oth | |
| 700 | 1 | |a Gonzalez, Fernando |e investigator |4 oth | |
| 700 | 1 | |a Woodward, K |e investigator |4 oth | |
| 700 | 1 | |a Lin, L M |e investigator |4 oth | |
| 700 | 1 | |a Suzuki, S |e investigator |4 oth | |
| 700 | 1 | |a Golshani, K |e investigator |4 oth | |
| 700 | 1 | |a Hanel, R |e investigator |4 oth | |
| 700 | 1 | |a Tawk, R |e investigator |4 oth | |
| 700 | 1 | |a Miller, D |e investigator |4 oth | |
| 700 | 1 | |a Mocco, J |e investigator |4 oth | |
| 700 | 1 | |a Froehler, M |e investigator |4 oth | |
| 700 | 1 | |a Hanel, R |e investigator |4 oth | |
| 700 | 1 | |a Sauvageau, E |e investigator |4 oth | |
| 700 | 1 | |a Kan, P |e investigator |4 oth | |
| 700 | 1 | |a Duckworth, Edward |e investigator |4 oth | |
| 700 | 1 | |a Morsi, Hesham |e investigator |4 oth | |
| 700 | 1 | |a Taussky, P |e investigator |4 oth | |
| 700 | 1 | |a Stevens, E |e investigator |4 oth | |
| 700 | 1 | |a Paru, Min |e investigator |4 oth | |
| 700 | 1 | |a Evans, A |e investigator |4 oth | |
| 700 | 1 | |a Liu, K |e investigator |4 oth | |
| 700 | 1 | |a Crowley, R |e investigator |4 oth | |
| 700 | 1 | |a Schweickert, P |e investigator |4 oth | |
| 700 | 1 | |a Fulks, L |e investigator |4 oth | |
| 700 | 1 | |a Walton, A |e investigator |4 oth | |
| 700 | 1 | |a Hixon, H |e investigator |4 oth | |
| 700 | 1 | |a Gingras, J M |e investigator |4 oth | |
| 700 | 1 | |a Schmitt, P |e investigator |4 oth | |
| 700 | 1 | |a Raper, D |e investigator |4 oth | |
| 700 | 1 | |a Durst, Christopher |e investigator |4 oth | |
| 700 | 1 | |a Starke, Robert |e investigator |4 oth | |
| 700 | 1 | |a Zauner, A |e investigator |4 oth | |
| 700 | 1 | |a Taylor, R |e investigator |4 oth | |
| 700 | 1 | |a Hou, Samuel |e investigator |4 oth | |
| 700 | 1 | |a Dabus, G |e investigator |4 oth | |
| 700 | 1 | |a Linfante, I |e investigator |4 oth | |
| 700 | 1 | |a Turner, R |e investigator |4 oth | |
| 700 | 1 | |a Chaudry, M |e investigator |4 oth | |
| 700 | 1 | |a Turk, A |e investigator |4 oth | |
| 700 | 1 | |a Spiotta, A |e investigator |4 oth | |
| 700 | 1 | |a Zaidat, O |e investigator |4 oth | |
| 700 | 1 | |a Fitzsimmons, B F |e investigator |4 oth | |
| 700 | 1 | |a Lynch, J |e investigator |4 oth | |
| 700 | 1 | |a Lazzaro, M |e investigator |4 oth | |
| 700 | 1 | |a Siddiqui, A |e investigator |4 oth | |
| 700 | 1 | |a Snyder, K |e investigator |4 oth | |
| 773 | 0 | 8 | |i Enthalten in |t Journal of neurointerventional surgery |d 2009 |g 15(2023), 11 vom: 14. Nov., Seite 1084-1089 |w (DE-627)NLM19772521X |x 1759-8486 |7 nnns |
| 773 | 1 | 8 | |g volume:15 |g year:2023 |g number:11 |g day:14 |g month:11 |g pages:1084-1089 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.1136/jnis-2022-019512 |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |d 15 |j 2023 |e 11 |b 14 |c 11 |h 1084-1089 | ||