Journal article
SUMMIT MAX: A randomized trial of the super large bore HiPoint Reperfusion System versus Vecta System for aspiration thrombectomy
Stroke (1970), Vol.56(8), pp.1980-1990
08/2025
DOI: 10.1161/STROKEAHA.125.051742
PMID: 40395106
Abstract
Rapid and complete recanalization is a primary goal in the endovascular treatment of large vessel occlusion stroke. The effectiveness and safety of super large bore aspiration catheters (.088" inner diameter) for the treatment of large vessel occlusion stroke have not been demonstrated in a randomized trial.
SUMMIT MAX was a prospective, randomized, controlled, open label clinical trial of patients with ICA and MCA M1 occlusions, comparing the super large bore HiPoint Reperfusion system (Route 92 Medical) to the Vecta Aspiration system (Stryker Neurovascular) (NCT05018650). We hypothesized that the effectiveness and safety of the HiPoint reperfusion system was non-inferior (12.5% non-inferiority margin) to the Vecta Aspiration system. The primary effectiveness endpoint was successful reperfusion, defined as mTICI ≥ 2b as adjudicated by an independent core lab, using only the assigned study device, with any use of a non-study device prior to or following use of study device defined as failure. The primary safety endpoint was symptomatic intracranial hemorrhage (sICH) within 24h (-8/+24) post-procedure.
There were 250 patients enrolled of whom 166 met criteria for the modified intent-to-treat population: 89 in HiPoint and 77 in Vecta. The median age was 69; 54.2% were female. Successful reperfusion with any adjunctive therapy counted as a failure was 77.5% (69/89) in the HiPoint group versus 50.6% (39/77) in the Vecta group (p<0.0001 for non-inferiority). SICH within 24h (-8/+24h) post procedure was similar between groups (3.6% vs. 2.7%, respectively). At 90 days, good clinical outcome (mRS<2) was achieved in 50.6% in the HiPoint group and 53.3% in the Vecta group (absolute difference -2.8%, 95% CI -18.2%, 12.7%, p=0.75).
In this randomized trial of patients with anterior large vessel occlusion, the super large bore HiPoint system was non-inferior to the Vecta system in achieving successful reperfusion, with a similar safety profile. This study supports the super large bore HiPoint system for mechanical thrombectomy.
NCT05018650.
Details
- Title: Subtitle
- SUMMIT MAX: A randomized trial of the super large bore HiPoint Reperfusion System versus Vecta System for aspiration thrombectomy
- Creators
- Thanh N Nguyen - Boston UniversitySantiago Ortega-Gutierrez - University of Iowa Hospitals and ClinicsEdgar A Samaniego - University of IowaGuilherme Dabus - Baptist Health South FloridaBen McGuinness - Auckland City HospitalJames Caldwell - Auckland City HospitalRyan Priest - Dayton Interventional RadiologyAnsaar Rai - West Virginia UniversityOsama O Zaidat - Mercy St. Vincent Medical CenterBradley A Gross - University of PittsburghRicardo A Hanel - The Neurological InstituteShane Sang Hyun Lee - Auckland City HospitalMuhammad Shazam Hussain - Cleveland ClinicHamza Shaikh - Cooper University Health CareMohamad Abdalkader - Boston UniversityRonald F Budzik - Riverside Methodist HospitalCraig Kilburg - University of UtahBritton K Woodward - Radiology, Vista Radiology, P.C, UNITED STATESMarco Colasurdo - Oregon Health & Science UniversityJesse Liu - Oregon Health & Science UniversityAlbert J Yoo - Neurointervention, Texas Stroke Institute, UNITED STATESPriyank Khandelwal - Rutgers, The State University of New JerseySoHyun Boo - West Virginia UniversityPhong Vu - Blanchette Rockefeller Neurosciences InstituteEugene Lin - Mercy St. Vincent Medical CenterMohammad AlMajali - University of IowaJasmeet Singh - Wake Forest UniversityAlhamza R Al-Bayati - UPMC Health SystemMichael J Lang - University of PittsburghMichael G Abraham - University of Kansas Medical CenterAmeer E Hassan - Valley Baptist Medical CenterPeter Pema - Riverside Community HospitalColeman O Martin - University of Missouri–Kansas CityRamesh Grandhi - University of UtahDaniel A Tonetti - Cooper University HospitalHarry Robert Hixson - Fort Sanders Regional Medical CenterAmin Aghaebrahim - The Neurological InstituteEric Sauvageau - The Neurological InstituteDileep R Yavagal - University of MiamiEsteban Cheng-Ching - Miami Valley HospitalJane Khalife - Neurology, Cooper Health, UNITED STATESItalo Linfante - Neuroscience InstituteVolodymyr Vulkanov - Rutgers, The State University of New JerseyJazba Haq Soomro - Neurointervention, Texas Stroke Institute, UNITED STATESJohanna T Fifi - Icahn School of Medicine at Mount SinaiLucien Maidan - Sisters of Mercy Health SystemAlexander Z Copelan - Abbott Northwestern HospitalClemens M Schirmer - Geisinger Neuroscience InstituteMark Bain - Cleveland ClinicGabor Toth - Cleveland ClinicMahesh V Jayaraman - Brown UniversityRoberta Novakovic-White - The University of Texas Southwestern Medical CenterSudhakar R Satti - Christiana Care Health SystemNicolas Villelli - Central Baptist HospitalPascal M Jabbour - Thomas Jefferson University HospitalMatthew Page - Auckland City HospitalDavina Joy Mcallister - Auckland City HospitalRobert Araujo Contreras - Boston UniversityDavid S Liebeskind - University of California, Los AngelesSteven W Hetts - Laboratoire d’Imagerie BiomédicaleRaul G Nogueira - University of PittsburghJoey English - California Pacific Medical CenterAjit S Puri - Radiology and Neurosurgery, University of Massachussets Medical School, UNITED STATES
- Resource Type
- Journal article
- Publication Details
- Stroke (1970), Vol.56(8), pp.1980-1990
- DOI
- 10.1161/STROKEAHA.125.051742
- PMID
- 40395106
- NLM abbreviation
- Stroke
- ISSN
- 1524-4628
- eISSN
- 1524-4628
- Publisher
- LIPPINCOTT WILLIAMS & WILKINS
- Grant note
- Route 92
Supportted by Route 92.
- Language
- English
- Electronic publication date
- 05/21/2025
- Date published
- 08/2025
- Academic Unit
- Neurology; Radiology; Iowa Neuroscience Institute; Neurosurgery
- Record Identifier
- 9984824330302771
Metrics
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