SUMMIT RISE Study of Acute Ischemic Stroke Patients

February 25, 2026 updated by: Route 92 Medical, Inc.

SUMMIT RISE Study of Acute Ischemic Stroke Patients Evaluating the Route 92 Medical Reperfusion Systems.

SUMMIT RISE Study of Acute Ischemic Stroke Patients

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

SUMMIT RISE Study of Acute Ischemic Stroke Patients Evaluating the Route 92 Medical Reperfusion Systems.

Study Type

Interventional

Enrollment (Estimated)

500

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Renee Kochevar Vice President, Clinical Research, PhD, ALM
  • Phone Number: 650-581-1179
  • Email: reneek@r92m.com

Study Locations

  • United States
    • Utah
      • West Jordan, Utah, United States, 84088
        • Recruiting
        • Route 92 Medical, Inc.
        • Contact:
          • Renee Kochevar Vice President, Clinical Research, PhD, ALM
          • Phone Number: 650-581-1179
          • Email: reneek@r92m.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Acute ischemic stroke patient initially treated (first pass) with a Route 92 Medical Reperfusion System
  • Informed consent completed and documented within 72 hours following thrombectomy procedure
  • Endovascular treatment initiated (defined as time of groin puncture) within 8 hours from time last known well
  • Age ≥ 18 years

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Route 92 Medical Reperfusion Systems
Aspiration of thrombus using the Route 92 Medical Reperfusion Systems
Device: Route 92 Medical Reperfusion Systems
Mechanical thrombectomy with the Route 92 Medical Reperfusion Systems

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Periprocedural eTICI measurement of revascularization
Time Frame: Periprocedural
Revascularization status checklist
Periprocedural

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Route 92 Medical, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 12, 2026

Primary Completion (Estimated)

May 31, 2029

Study Completion (Estimated)

November 30, 2029

Study Registration Dates

First Submitted

February 12, 2026

First Submitted That Met QC Criteria

February 25, 2026

First Posted (Actual)

February 27, 2026

Study Record Updates

Last Update Posted (Actual)

February 27, 2026

Last Update Submitted That Met QC Criteria

February 25, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIP 4262

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Depending on trial completion.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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