SUMMIT RISE Study of Acute Ischemic Stroke Patients | NCT07436156

Studies
SUMMIT RISE Study of Acute Ischemic Stroke Patients

NCT07436156

Sponsor

Route 92 Medical, Inc.

Status

Recruiting

Last Update Posted

Feb 27, 2026Actual

Enrollment

500Estimated

Phase

Phase 4

Conditions

Acute Ischemic Stroke

Interventions

Route 92 Medical Reperfusion Systems

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 12, 2026Actual

Primary Completion Date

May 31, 2029Estimated

Completion Date

Nov 30, 2029Estimated

First Submitted Date

Feb 12, 2026

First Submission Date that Met QC Criteria

Feb 25, 2026

First Posted Date

Feb 27, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 25, 2026

Last Update Posted Date

Feb 27, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

SUMMIT RISE Study of Acute Ischemic Stroke Patients

Detailed Description

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Route 92 Medical Reperfusion Systems	Experimental	Aspiration of thrombus using the Route 92 Medical Reperfusion Systems	Device: Route 92 Medical Reperfusion Systems

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Route 92 Medical Reperfusion Systems	Device	Mechanical thrombectomy with the Route 92 Medical Reperfusion Systems	Route 92 Medical Reperfusion Systems

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Renee Kochevar Vice President, Clinical Research, PhD, ALM	Contact	650-581-1179		reneek@r92m.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Route 92 Medical, Inc.	Recruiting	West Jordan	Utah	84088	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Depending on trial completion.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000083242	Ischemic Stroke

Ancestor Terms

ID	Term
D020521	Stroke
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided