A Randomized, Controlled Trial to Evaluate the Safety and Effectiveness of the Route 92 Medical R… (NCT05018650) | Clinical Trial Compass
CompletedNot Applicable
A Randomized, Controlled Trial to Evaluate the Safety and Effectiveness of the Route 92 Medical Reperfusion System (SUMMIT MAX)
United States250 participantsStarted 2021-12-21
Plain-language summary
The SUMMIT MAX study is a prospective, randomized, controlled, interventional clinical trial to evaluate the safety and effectiveness of the Route 92 Medical MonoPoint® Reperfusion System with the Hi Point 88 and HiPoint 70 Reperfusion Catheters for aspiration thrombectomy in acute ischemic stroke patients.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. The consent process has been completed and documented according to applicable country regulations and as approved by the IRB / Ethics Committee
✓. Age \>=18 years
✓. Patient presenting with clinical signs consistent with an acute ischemic stroke
✓. Baseline National Institutes of Health Stroke Scale (NIHSS) score \>= 6
✓. Pre-stroke modified Rankin Score (mRS) \<= 2
✓. Baseline ASPECTS \>= 6
✓. Endovascular treatment initiated (defined as time of groin puncture) within 8 hours from time last known well
✓. If indicated, thrombolytic therapy shall be initiated per clinical guidelines. If eligible for thrombolytic therapy, subjects should be treated as soon as possible and lytic use should not be delayed regardless of potential eligibility for mechanical neurothrombectomy.
Exclusion criteria
✕. Known pregnancy or breast feeding
✕. In the Investigator's opinion, any known comorbidity (including COVID-19 positivity) that may complicate treatment or prevent improvement or follow-up
✕. Known serious, advanced, or terminal illness with anticipated life expectancy \< 12 months
✕. Known history of severe allergy to contrast medium
What they're measuring
1
Proportion of subjects with successful arterial revascularization defined as a modified Thrombolysis in Cerebrovascular Infarction (mTICI) score of 2b or greater
Timeframe: During procedure
2
Incidence of all symptomatic intracerebral hemorrhage (sICH)