TY - JOUR
T1 - Stroke thrombectomy with a novel reperfusion system including a 0.088" aspiration catheter
T2 - The Imperative Trial
AU - Mack, William
AU - De Leacy, Reade Andrew
AU - Grossberg, Jonathan A.
AU - Majidi, Shahram
AU - Tomalty, Robert Dana
AU - Mokin, Maxim
AU - Vargas, Jan
AU - Cucchiara, Brett L.
AU - Snyder, Kenneth V.
AU - Mascitelli, Justin
AU - Parada, Victoria
AU - Shakir, Hakeem J.
AU - Rosenbaum-Halevi, David
AU - Aghaebrahim, Amin
AU - Hoit, Daniel
AU - Yim, Benjamin
AU - Tenser, Matthew S.
AU - Al-Bayati, Alhamza R.
AU - Milburn, James M.
AU - Nimjee, Shahid M.
AU - Haranhalli, Neil
AU - Nahhas, Michael
AU - Shaff, Darryn
AU - Layton, Kennith F.
AU - Beaty, Narlin
AU - Starke, Robert M.
AU - Hawk, Harris
AU - Haussen, Diogo C.
AU - Pabaney, Aqueel
AU - Kellner, Christopher Paul
AU - Nogueira, Raul G.
N1 - Publisher Copyright: © Author(s) (or their employer(s)) 2025. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ Group.
PY - 2025
Y1 - 2025
N2 - Background: Mechanical thrombectomy is the standard of care for large vessel occlusion (LVO) stroke, yet most device trials focus on individual technologies rather than complete systems. Objective: To evaluate the safety and efficacy of the Zoom Reperfusion System compared with performance goals derived from a meta-analysis of trials using established thrombectomy technologies. Methods: Prospective, multicenter, non-randomized, investigational device exemption trial conducted across 26 United States centers from October 2021 to March 2024. Adults with anterior circulation LVO stroke within 8 hours of onset were treated using the Zoom System, which includes aspiration catheters ranging from 0.035′ to 0.071′, and a novel 0.088′ intracranial guide/aspiration catheter. The primary efficacy endpoint was successful reperfusion (modified Thrombolysis in Cerebral Infarction (mTICI) 2b-3) within three passes using Zoom-only components, adjudicated by an independent core laboratory. The primary safety endpoint was symptomatic intracranial hemorrhage (sICH). Secondary outcomes included final reperfusion, first-pass success, time to reperfusion, 90-day modified Rankin Scale (mRS), and mortality. Results: Among 260 patients (median age 68 years; median National Institutes of Health Stroke Scale (NIHSS) 15), successful reperfusion within three passes was achieved in 83% (216/259; 95% CI: 78% to 89%), exceeding the performance goal (p<0.001). Final reperfusion was 92%, with 5.5% requiring rescue devices. First-pass mTICI 2b-3 success was 57%. Median puncture-to-reperfusion time was 19 min. At 90 days, 55% achieved mRS 0-2. The sICH rate was 1.9%, and 90-day mortality was 12.7%. Conclusions: The Zoom Reperfusion System demonstrated a safety and efficacy profile exceeding prespecified contemporary performance metrics with potential to significantly shorten reperfusion times and reduce the need for rescue therapy. Trial registration number: ClinicalTrials.gov - Identifier:NCT04129125.
AB - Background: Mechanical thrombectomy is the standard of care for large vessel occlusion (LVO) stroke, yet most device trials focus on individual technologies rather than complete systems. Objective: To evaluate the safety and efficacy of the Zoom Reperfusion System compared with performance goals derived from a meta-analysis of trials using established thrombectomy technologies. Methods: Prospective, multicenter, non-randomized, investigational device exemption trial conducted across 26 United States centers from October 2021 to March 2024. Adults with anterior circulation LVO stroke within 8 hours of onset were treated using the Zoom System, which includes aspiration catheters ranging from 0.035′ to 0.071′, and a novel 0.088′ intracranial guide/aspiration catheter. The primary efficacy endpoint was successful reperfusion (modified Thrombolysis in Cerebral Infarction (mTICI) 2b-3) within three passes using Zoom-only components, adjudicated by an independent core laboratory. The primary safety endpoint was symptomatic intracranial hemorrhage (sICH). Secondary outcomes included final reperfusion, first-pass success, time to reperfusion, 90-day modified Rankin Scale (mRS), and mortality. Results: Among 260 patients (median age 68 years; median National Institutes of Health Stroke Scale (NIHSS) 15), successful reperfusion within three passes was achieved in 83% (216/259; 95% CI: 78% to 89%), exceeding the performance goal (p<0.001). Final reperfusion was 92%, with 5.5% requiring rescue devices. First-pass mTICI 2b-3 success was 57%. Median puncture-to-reperfusion time was 19 min. At 90 days, 55% achieved mRS 0-2. The sICH rate was 1.9%, and 90-day mortality was 12.7%. Conclusions: The Zoom Reperfusion System demonstrated a safety and efficacy profile exceeding prespecified contemporary performance metrics with potential to significantly shorten reperfusion times and reduce the need for rescue therapy. Trial registration number: ClinicalTrials.gov - Identifier:NCT04129125.
KW - Catheter
KW - Reperfusion
KW - Stroke
KW - Thrombectomy
UR - https://www.scopus.com/pages/publications/105011258624
U2 - 10.1136/jnis-2025-023719
DO - 10.1136/jnis-2025-023719
M3 - Article
SN - 1759-8478
JO - Journal of NeuroInterventional Surgery
JF - Journal of NeuroInterventional Surgery
ER -