SUMMIT MAX: A randomized trial of the super large bore HiPoint Reperfusion System versus Vecta System for aspiration thrombectomy.
Background: 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.
Methods: 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.
Results: 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).
Conclusion: 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. Registration: NCT05018650.