Medical Reperfusion Device for Stroke

Recruiting in Palo Alto (17 mi)

+30 other locations

Overseen byGuilherme Dabus, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Route 92 Medical, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for adults over 18 with acute ischemic stroke, showing specific clinical signs and a certain severity level. They must have had a relatively independent lifestyle before the stroke and be within 8 hours from when they were last known well. Pregnant or breastfeeding individuals, those with severe allergies to contrast media, recent strokes, certain blood disorders, or life expectancy less than a year are excluded.

Inclusion Criteria

Your baseline ASPECTS score is 6 or higher.

I am a candidate for a specific clot removal procedure in my brain.

My treatment started within 8 hours after I was last known to be well.

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Exclusion Criteria

Known to be participating in another study involving an investigational device or drug

Your blood sugar level is lower than 50 mg/dL or higher than 400 mg/dL before starting the study.

I might have an infection in my heart or blood clot.

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Treatment Details

Interventions

Route 92 Medical Reperfusion System (Aspiration Thrombectomy Device)

Trial OverviewThe SUMMIT MAX study tests the Route 92 Medical MonoPoint Reperfusion System's safety and effectiveness in removing blood clots from the brain during an acute ischemic stroke through aspiration thrombectomy (suctioning out the clot).

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Route 92 Medical Monopoint Reperfusion SystemExperimental Treatment1 Intervention

Aspiration thrombectomy with the Route 92 Medical HiPoint 88 and HiPoint 70 Reperfusion Catheters as part of the Monopoint Reperfusion System to treat acute ischemic stroke

Group II: Aspiration PredicateActive Control1 Intervention

Aspiration thrombectomy with a predicate aspiration device to treat acute ischemic stroke