Recruiting

Acute Ischemic Stroke

Sponsor:

Route 92 Medical, Inc.

Code:

NCT07436156

Conditions

Acute Ischemic Stroke

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Route 92 Medical Reperfusion Systems

Study Details

Brief summary:

SUMMIT RISE Study of Acute Ischemic Stroke Patients

Conditions

Acute Ischemic Stroke

Study ID

NCT07436156

Start date

Feb 12, 2026

Status verified date

Feb, 2026

Completion date

Nov 30, 2029

Anticipated

Primary completion date

May 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

500 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Route 92 Medical Reperfusion Systems

Aspiration of thrombus using the Route 92 Medical Reperfusion Systems

Interventions

Route 92 Medical Reperfusion Systems

Mechanical thrombectomy with the Route 92 Medical Reperfusion Systems

Primary outcome measure

  • Periprocedural eTICI measurement of revascularization [ Time Frame: Periprocedural ]

Central Contacts and Locations

Central contacts

Renee Kochevar Vice President, Clinical Research, PhD, ALM

650-581-1179reneek@r92m.com

Locations

Route 92 Medical, Inc.

Recruiting

West Jordan, Utah, United States, 84088

Contacts

Renee Kochevar Vice President, Clinical Research, PhD, ALM

650-581-1179reneek@r92m.com

More Information

Sponsor

Route 92 Medical, Inc.

Last update posted

Feb 27, 2026

Last verified

Feb, 2026

Keywords

  • Acute Ischemic Stroke

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Route 92 Medical, Inc. on 2026-02-27.