Who is sponsoring NCT05018650?

NCT05018650 is sponsored by Route 92 Medical, Inc..

What drugs are being tested in NCT05018650?

Interventions in NCT05018650: Route 92 Medical Reperfusion System.

What condition does NCT05018650 study?

NCT05018650 studies Acute Ischemic Stroke.

Is NCT05018650 still recruiting?

NCT05018650 is currently completed. Last updated 9 April 2025.

Last reviewed 2025-04-09 · How we verify

NCT05018650

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Randomized, Controlled Trial to Evaluate the Safety and Effectiveness of the Route 92 Medical Reperfusion System (SUMMIT MAX)

Completed NA Last updated 9 April 2025

What this trial tests

NA trial testing Route 92 Medical Reperfusion System in Acute Ischemic Stroke in 250 participants. Completed in 22 May 2024.

Timeline

21 December 2021

Primary endpoint
19 February 2024

22 May 2024

Quick facts

Lead sponsor	Route 92 Medical, Inc.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	250
Start date	21 December 2021
Primary completion	19 February 2024
Estimated completion	22 May 2024
Sites	30 locations across New Zealand, United States

Drugs / interventions tested

Route 92 Medical Reperfusion System

Conditions studied

Acute Ischemic Stroke — all drugs for Acute Ischemic Stroke →

Sponsor

Route 92 Medical, Inc. — full company profile →

Who can join

18 and older, any sex, with Acute Ischemic Stroke. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The SUMMIT MAX study is a prospective, randomized, controlled, interventional clinical trial to evaluate the safety and effectiveness of the Route 92 Medical MonoPoint® Reperfusion System with the Hi Point 88 and HiPoint 70 Reperfusion Catheters for aspiration thrombectomy in acute ischemic stroke patients.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

SUMMIT MAX: A Randomized Trial of the Super Large Bore HiPoint Reperfusion System Versus Vecta System for Aspiration Thrombectomy.
Nguyen TN, Dabus G, McGuinness B, Caldwell J, et al · · 2025 · cited 7× · PMID 40395106 · DOI 10.1161/strokeaha.125.051742
Multicenter experience of the Monopoint reperfusion system in acute large vessel occlusion stroke thrombectomy.
Koneru M, Khalife J, Colasurdo M, Priest R, et al · · 2026 · cited 2× · PMID 40633937 · DOI 10.1136/jnis-2025-023398
Unmet Needs in Acute Ischemic Stroke: Overcoming Recalcitrant Clots.
Mirza M, Ulfert C, Ulfert C, McCarthy R, et al · · 2025 · PMID 40576345 · DOI 10.1097/crd.0000000000000977

Verify or expand the search:

Other recruiting trials for Acute Ischemic Stroke

Currently open trials in the same condition.

NCT07115940 — Medical Management With Endovascular Thrombectomy Versus Medical Management Alone in Patients Presenting Beyond 24 Hours · NA · recruiting
NCT07404852 — Non-invasive Vagus Nerve Stimulation to Reduce Inflammation and Brain Injury Blood Biomarkers Following an Acute Ischemi · NA · recruiting
NCT07361302 — A Study to Test if Tenecteplase Helps People to Recover From an Acute Stroke When Given More Than 4.5 Hours After the Pe · Phase 3 · recruiting
NCT07436156 — SUMMIT RISE Study of Acute Ischemic Stroke Patients · Phase 4 · recruiting
NCT07203625 — Tenecteplase Before Interhospital Transfer in Acute Basilar Artery Occlusion at 4.5 to 24 Hours · Phase 4 · recruiting

Other Route 92 Medical, Inc. trials

Trials by the same sponsor.

NCT07436156 — SUMMIT RISE Study of Acute Ischemic Stroke Patients · Phase 4 · recruiting
NCT05429658 — Single Arm Trial to Evaluate the Safety and Effectiveness of the Route 92 Medical Reperfusion System · NA · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05018650 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Route 92 Medical, Inc.
Last refreshed: 9 April 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05018650.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing