SUMMIT RISE: Route 92 mechanical reperfusion for acute ischemic stroke
Official title: SUMMIT RISE Study of Acute Ischemic Stroke Patients Evaluating the Route 92 Medical Reperfusion Systems.
Run by Route 92 Medical, Inc. · NCT07436156 · Data updated 2026-11-12
This will test the Route 92 mechanical reperfusion system to see if it helps restore blood flow and improve recovery in adults treated for acute ischemic stroke who received the device as the first pass during thrombectomy.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 500 (estimated) |
| Sponsor | Route 92 Medical, Inc. Industry-sponsored |
| Locations | 1 site (West Jordan, Utah) |
| Status | Recruiting |
| Started | February 12, 2026 |
| Main results expected | May 31, 2029 |
| Study ends | November 30, 2029 |
| Registry record updated | February 27, 2026 |
| Trial ID | NCT07436156 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18 years) with acute ischemic stroke who were initially treated (first pass) with the Route 92 device during thrombectomy, with endovascular treatment started within 8 hours of last known well and consent documented within 72 hours.
✕Probably not a fit
Patients who were not treated with the Route 92 device as the first pass, those treated outside the 8‑hour window, or patients with hemorrhagic or non‑ischemic stroke are unlikely to be eligible or to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
SUMMIT RISE is a phase 4 interventional program collecting post‑market data on the Route 92 Medical Reperfusion System when used as the first pass during endovascular thrombectomy for acute ischemic stroke. Eligible adults had groin puncture within 8 hours of last known well and provide informed consent within 72 hours after the procedure. The protocol captures device performance, safety events, and clinical outcomes such as reperfusion rates and functional status over follow‑up. The study is sponsored and conducted at Route 92 Medical, Inc. in West Jordan, Utah.
Why it matters
Potential benefit: If successful, the Route 92 system could increase rates of successful vessel reperfusion and improve functional recovery after acute ischemic stroke.
How similar studies have gone: Large randomized trials have shown mechanical thrombectomy improves outcomes for large‑vessel ischemic stroke, but device‑specific post‑market data for the Route 92 system are limited and this phase 4 effort aims to add that evidence.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Route 92 Medical, Inc.
West Jordan, Utah, United States Recruiting
Study contacts
- Study coordinator: Renee Kochevar Vice President, Clinical Research, PhD, ALM
- Email: reneek@r92m.com
- Phone: 650-581-1179
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.