SUMMIT RISE Study of Acute Ischemic Stroke Patients

Purpose

SUMMIT RISE Study of Acute Ischemic Stroke Patients

Condition

  • Acute Ischemic Stroke

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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 Design

Phase
Phase 4
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

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

More Details

NCT ID
NCT07436156
Status
Recruiting
Sponsor
Route 92 Medical, Inc.

Study Contact

Renee Kochevar Vice President, Clinical Research, PhD, ALM
650-581-1179
reneek@r92m.com

Detailed Description

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