NCT07436156

Brief Summary

SUMMIT RISE Study of Acute Ischemic Stroke Patients

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for phase_4

Timeline
42mo left

Started Feb 2026

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress9%
Feb 2026Nov 2029

First Submitted

Initial submission to the registry

February 12, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

February 12, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 27, 2026

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2029

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2029

Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

3.3 years

First QC Date

February 12, 2026

Last Update Submit

February 25, 2026

Conditions

Acute Ischemic Stroke

Keywords

Acute Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

  • Periprocedural eTICI measurement of revascularization

    Revascularization status checklist

    Periprocedural

Study Arms (1)

Route 92 Medical Reperfusion Systems

EXPERIMENTAL

Aspiration of thrombus using the Route 92 Medical Reperfusion Systems

Device: Route 92 Medical Reperfusion Systems

Interventions

Route 92 Medical Reperfusion SystemsDEVICE

Mechanical thrombectomy with the Route 92 Medical Reperfusion Systems

Route 92 Medical Reperfusion Systems

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Route 92 Medical, Inc.

West Jordan, Utah, 84088, United States

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Renee Kochevar Vice President, Clinical Research, PhD, ALM

CONTACT

650-581-1179reneek@r92m.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2026

First Posted

February 27, 2026

Study Start

February 12, 2026

Primary Completion (Estimated)

May 31, 2029

Study Completion (Estimated)

November 30, 2029

Last Updated

February 27, 2026

Record last verified: 2026-02

Locations

US(1)