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A Randomized, Controlled Trial to Evaluate the Safety and Effectiveness of the Route 92 Medical Reperfusion System (SUMMIT MAX)

NCT05018650 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2025-04-09

No results posted yet for this study

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.

Conditions

  • Acute Ischemic Stroke

Interventions

DEVICE

Route 92 Medical Reperfusion System

Mechanical thrombectomy for acute ischemic stroke patients with large vessel occlusions will be performed with direct aspiration consisting of navigating a large-bore catheter up to the face of the clot and initiating vacuum suction.

Sponsors & Collaborators

  • Route 92 Medical, Inc.

    lead INDUSTRY

Principal Investigators

  • Guilherme Dabus, MD · Baptist Health - Miami

  • Ajit Puri, MD · University of Massachusetts, Worcester

  • Thanh Nguyen, MD · Boston Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-21
Primary Completion
2024-02-19
Completion
2024-05-22
FDA Device
Yes

Countries

  • United States
  • New Zealand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05018650 on ClinicalTrials.gov