Abstract
Abstract 24: Primary Results Of The Preset For Occlusive Stroke Treatment Randomized Clinical Trial
Stroke (1970), Vol.54(S_1), p.A24
02/01/2023
DOI: 10.1161/str.54.suppl_1.24
Abstract
Byline: Raul G Nogueira, Univ of Pittsburgh, Pittsburgh, PA; Ricardo Hanel, Lyerly Neurosurgery, Jacksonville, FL; Joachim Klisch, Helios General Hosp, Erfurt, Germany; Markus Moehlenbruch, Heidelberg Univ Hosp, Heidelberg; Hormozd Bozorgchami, Baylor Univ, The Woodlands, TX; Edgar A Samaniego, Univ of Iowa Hosps, Iowa City, IA; David S Liebeskind, UCLA, Los Angeles, CA; Donald Lobsien, Helios General Hosp, Erfurt, Germany; Daniel Pielenz, Helios General Hosp, Erfurt, Germany; Eric Sauvageau, Tampa, FL; Amin N Aghaebrahim, Baptist Health, Ponte Vedra Beach, FL; Wayne M Clark, Oregon Stroke Cntr at OHSU, Portland, OR; Ryan Priest, Oregon Health and Science Universit, Portland, OR; Santiago Ortega-Gutierrez, UNIVERSITY OF IOWA HOSPITALS, Iowa City, IA; Demetrius Lopes, Chicago, IL; Joshua Billingsley, Advocate Aurora Health, Park Ridge, IL; Diogo C Haussen, EMORY UNIVERSITY SCHOOL OF MEDICINE, Atlanta, GA; Alhamza R Al-Bayati, UPMC Stroke Institute, Pittsburgh, PA; Adnan H Siddiqui, UNIVERSITY AT BUFFALO, Buffalo, NY; Michael Chen, Rush Univ Med Cntr, Chicago, IL; Peter Schramm, Univ, Heidelberg; Sandra Narayanan, Pittsburgh, PA; Christian Roth, Standort Klinikum Bremen Mitte, Bremen, Germany; Tobias Boeckh-Behrens, Klinikum Rechts der Isar der, Munich, Germany; Ameer E Hassan, UTRGV - VALLEY BAPTIST MEDICAL CENT, Harlingen, TX; Johanna T Fifi, Mount Sinai Health System, New York, NY; Ronald Budzik, Riverside Methodist Hosp, Columbus, OH; Jason W Tarpley, Pacific Neuroscience Institute, Torrance, CA; Robert Starke, Miami, FL; Eytan Raz, Brooklyn, NY Importance: Clinical trials focusing on new mechanical thrombectomy (MT) technologies have been typically single-arm studies using historical comparison data to determine the safety and efficacy of the novel device. To date, there has not been a contemporaneous prospective, randomized, controlled study comparing standard to newer designed stent-retrievers. Objective: To evaluate the safety and efficacy of the pRESET (phenox Ltd) compared to the Solitaire (Medtronic Corp) thrombectomy devices in the treatment of large vessel occlusion strokes (LVOS). Methods: Multicenter, prospective, randomized, open-label, blinded endpoint, core lab adjudicated, non-inferiority trial that enrolled 340 patients from October 2019 to February 2022 across 19 US & 5 German sites. Patients aged [greater than or equal] 18 years with either anterior or posterior circulation LVOS were included up to 8 hours after symptom onset. Patients were randomly assigned in a 1:1 ratio to either pRESET or Solitaire for the first three device passes.The Primary Endpoint was the proportion of patients achieving a modified Rankin Scale score of 0-2, analyzed by intent to treat with a non-inferiority margin of 0.125 based on the lower bound 95% Confidence Interval. The Primary Safety Endpoint was the proportion of subjects with device- or procedure-related symptomatic intracerebral hemorrhage at 24 (-8/+12) hours as per the SITS-MOST criteria. Secondary Outcome Measures included the rates of (1) Successful Revascularization (defined as expanded Thrombolysis in Cerebrovascular Infarction [eTICI] [greater than or equal] 2b50 ëñ3 passes of the assigned device; (2) eTICI [greater than or equal] 2c following the first pass of the assigned device; (3) 90-day mortality and (4) Distribution of 90-day mRS across the entire spectrum of disability (ordinal shift). Results: The study database was locked in August 2022. The analysis is ongoing and the final results will be presented at the 2023 International Stroke Conference. Conclusions and Relevance: PROST is the first randomized clinical trial aiming to compare a novel versus an established stent-retriever technology, establishing a new scientific benchmark for stroke device trials. (ClinicalTrials.gov: NCT03994822).
Details
- Title: Subtitle
- Abstract 24: Primary Results Of The Preset For Occlusive Stroke Treatment Randomized Clinical Trial
- Creators
- Raul G Nogueira - University of PittsburghRicardo Hanel - Lyerly Neurosurgery, Jacksonville, FLJoachim Klisch - Helios Klinikum ErfurtMarkus Moehlenbruch - Heidelberg Univ Hosp, HeidelbergHormozd Bozorgchami - Baylor UniversityEdgar A Samaniego - University of IowaDavid S Liebeskind - University of California, Los AngelesDonald LobsienDaniel PielenzEric SauvageauAmin N AghaebrahimWayne M ClarkRyan PriestSantiago Ortega-Gutiérrez - University of Iowa, RadiologyDemetrius LopesJoshua BillingsleyDiogo C Haussen - Emory UniversityAlhamza R Al-BayatiAdnan H Siddiqui - University at Buffalo, State University of New York
- Resource Type
- Abstract
- Publication Details
- Stroke (1970), Vol.54(S_1), p.A24
- Publisher
- Lippincott Williams & Wilkins, WK Health
- DOI
- 10.1161/str.54.suppl_1.24
- ISSN
- 0039-2499
- eISSN
- 1524-4628
- Language
- English
- Date published
- 02/01/2023
- Description audience
- Academic
- Academic Unit
- Neurosurgery; Radiology; Neurology; Iowa Neuroscience Institute
- Record Identifier
- 9984367614602771
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