Acute Ischemic StrokePhase 4NCT07436156
SUMMIT RISE Study of Acute Ischemic Stroke Patients
A Phase 4 study testing Route 92 Medical Reperfusion Systems in people with Acute Ischemic Stroke, run by Route 92 Medical, Inc. at 1 site in United States.
Trial summary
SUMMIT RISE Study of Acute Ischemic Stroke Patients Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Route 92 Medical Reperfusion Systems
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Feb 2026to 30 Nov 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Route 92 Medical, Inc.
West Jordan, Utah, 84088
Renee Kochevar Vice President, Clinical Research, PhD, ALM, 650-581-1179, reneek@r92m.com
About this study
Official title: SUMMIT RISE Study of Acute Ischemic Stroke Patients Evaluating the Route 92 Medical Reperfusion Systems.
SUMMIT RISE Study of Acute Ischemic Stroke Patients
Read the detailed description
SUMMIT RISE Study of Acute Ischemic Stroke Patients Evaluating the Route 92 Medical Reperfusion Systems.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Route 92 Medical Reperfusion Systems
- Keywords
- Acute Ischemic Stroke
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Route 92 Medical Reperfusion SystemsDevice
Mechanical thrombectomy with the Route 92 Medical Reperfusion Systems
| Study group | Role | What they receive |
|---|---|---|
| Route 92 Medical Reperfusion Systems | Experimental | Aspiration of thrombus using the Route 92 Medical Reperfusion Systems Receives: Device: Route 92 Medical Reperfusion Systems |
What is being measured
The primary outcome is the main question the study is designed to answer.
Periprocedural eTICI measurement of revascularization
Revascularization status checklist
Measured: Periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start12 Feb 2026
- Primary completion31 May 2029 (estimated)
- Study completion30 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Route 92 Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07436156
- Sponsor's protocol ID
- CIP 4262
- Status last verified
- Feb 2026
- First submitted
- 12 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: Depending on trial completion.
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SUMMIT RISE Study of Acute Ischemic Stroke Patients Evaluating the Route 92 Medical Reperfusion Systems.
- ClinicalTrials.gov ID
- NCT07436156
- Acronym / sponsor ID
- CIP 4262
- Conditions
- Acute Ischemic Stroke
- Keywords
- Acute Ischemic Stroke
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Route 92 Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Feb 2026 (actual)
- Primary completion
- 31 May 2029 (estimated)
- Study completion
- 30 Nov 2029 (estimated)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Route 92 Medical Reperfusion Systems | Experimental | Device: Route 92 Medical Reperfusion SystemsAspiration of thrombus using the Route 92 Medical Reperfusion Systems |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Route 92 Medical Reperfusion SystemsMechanical thrombectomy with the Route 92 Medical Reperfusion Systems | Device | Route 92 Medical Reperfusion Systems |
Primary outcome
Periprocedural eTICI measurement of revascularization
Time frame: Periprocedural
Revascularization status checklist
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: Undecided. Depending on trial completion.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Route 92 Medical Reperfusion Systems in people with Acute Ischemic Stroke, run by Route 92 Medical, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Renee Kochevar Vice President, Clinical Research, PhD, ALM (650-581-1179, reneek@r92m.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Periprocedural eTICI measurement of revascularization (time frame: Periprocedural). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026; AzTrials last refreshed its copy on 6 Nov 2026.