Route 92 Medical Reperfusion System for Stroke, Acute, Stroke Ischemic

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Texas Stroke Institute, Plano, TX
Stroke, Acute, Stroke Ischemic+1 More
Route 92 Medical Reperfusion System - Device
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

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

See full description

Eligible Conditions

  • Stroke, Acute, Stroke Ischemic

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether Route 92 Medical Reperfusion System will improve 2 primary outcomes in patients with Stroke, Acute, Stroke Ischemic. Measurement will happen over the course of During procedure.

During procedure
Proportion of subjects with successful arterial revascularization defined as a modified Thrombolysis in Cerebrovascular Infarction (mTICI) score of 2b or greater
within 24 hours post-procedure
Incidence of all symptomatic intracerebral hemorrhage (sICH)

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Aspiration Predicate
1 of 2
Route 92 Medical Reperfusion System
1 of 2
Active Control
Experimental Treatment

This trial requires 220 total participants across 2 different treatment groups

This trial involves 2 different treatments. Route 92 Medical Reperfusion System is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Route 92 Medical Reperfusion System
Device
Aspiration thrombectomy with the Route 92 Reperfusion System to treat acute ischemic stroke
Aspiration Predicate
Device
Aspiration thrombectomy with a predicate aspiration device to treat acute ischemic stroke

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: within 24 hours post-procedure
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly within 24 hours post-procedure for reporting.

Closest Location

Texas Stroke Institute - Plano, TX

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 9 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
The consent process has been completed and documented according to applicable country regulations and as approved by the IRB / Ethics Committee
Age >=18 years and <= 85
Patient presenting with clinical signs consistent with an acute ischemic stroke
Baseline National Institutes of Health Stroke Scale (NIHSS) score >= 6
Pre-stroke modified Rankin Score (mRS) <= 1
Baseline ASPECTS >= 6
Endovascular treatment initiated (defined as time of first angiogram) within 8 hours from time last known well
If indicated, thrombolytic therapy shall be initiated per clinical guidelines. If eligible for thrombolytic therapy, subjects should be treated as soon as possible and lytic use should not be delayed regardless of potential eligibility for mechanical neurothrombectomy.
The patient is indicated for aspiration neurothrombectomy with the Route 92 Medical Reperfusion System as determined by the Investigator Angiographic confirmation of a large vessel occlusion of the M1 segment of the middle cerebral artery or distal internal carotid artery

Patient Q&A Section

What are the signs of stroke, acute, stroke ischemic?

"A stroke event is characterized by a set of clinical signs of stroke. These signs include weakness or numbness in the area of the stroke and loss of consciousness." - Anonymous Online Contributor

Unverified Answer

Can stroke, acute, stroke ischemic be cured?

"Clinical trials for acute stroke should focus on prevention protocols; as of 2002, there has still not been a significant shift in the research toward stroke prevention. If the goal of stroke prevention is to produce a better quality of life, then more money should be allocated for research on the neurological and other long-term results of stroke, including the cognitive and functional outcome of stroke patients." - Anonymous Online Contributor

Unverified Answer

What causes stroke, acute, stroke ischemic?

"Symptoms, acute brain damage on cerebral MRI, and family history do NOT indicate ischemic cerebral stroke. Other factors in this population might include a high-risk profile of depression, hypertension, and elevated homocysteine levels all associated with ischemic stroke." - Anonymous Online Contributor

Unverified Answer

How many people get stroke, acute, stroke ischemic a year in the United States?

"The burden of stroke is heavy in the U.S. with the prevalence of stroke ischemic being about 10 times higher than that of CAD. We must prepare for and invest in a comprehensive strategy to reduce the morbidity and mortality of stroke and stroke ischemic." - Anonymous Online Contributor

Unverified Answer

What is stroke, acute, stroke ischemic?

"Stroke is the most common cause of a neurological deficit in adulthood. About 10% of the general population experienced a stroke in 2010. The incidence of stroke among the population is likely to increase in future due to lifestyle factors. The major risk factors for stroke are the usual cardiovascular risk factors. It was evident that cardio-cerebro-vascular diseases are being recognized in the modern era due to increased usage of imaging technology." - Anonymous Online Contributor

Unverified Answer

What are common treatments for stroke, acute, stroke ischemic?

"What are common treatments for acute stroke ischemia are aspirin and thrombolytic agents such as tissue plasminogen activator and enoxaparin. Patients that have acute stroke ischemic are treated with aspirin, anticoagulants (aspirin-warfarin combination), antiplatelets, and NSAIDs and antihyperglycemia (metformin/glipizide) are often prescribed. These treatments are also effective on improving functionality for these patients." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating stroke, acute, stroke ischemic?

"The development of modern magnetic resonance imaging (MRI) devices has brought some new possibilities of treatments for acute stroke, acute ischemic stroke, and for recovery (including rehabilitation) after the brain is damaged from a stroke." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in route 92 medical reperfusion system for therapeutic use?

"The route 92 system in recent years has come a great advance, and we think that this system will be universally used, as it can be easily used by the clinical technicians at all levels, and more so than conventional systems." - Anonymous Online Contributor

Unverified Answer

How serious can stroke, acute, stroke ischemic be?

"About 10% of patients who have an ischemic stroke die within 30 days, and the risk of stroke death increases threefold after the first 90 days after onset. The overall risk of stroke death is about 5%--about 3% by 90 days and about 2% by 190 days." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of stroke, acute, stroke ischemic?

"It was found that stroke was caused primarily by atherosclerosis. The number of affected women increased as both the age and the number of children increased, because the time taken to conceive children increased as well." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for stroke, acute, stroke ischemic?

"In this patient sample, only the presence of stroke complaints in conjunction with a history of previous stroke was associated with a higher likelihood of benefiting from clinical trials. This suggests that patients with a history of stroke should be considered candidates for clinical trials as the condition of their stroke might be related to the treatment being tested. Clinical trial programs should also consider the availability of such patients in their geographic region to ensure equitable treatment allocation." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving route 92 medical reperfusion system?

"The medical reperfusion system using the SENTI protocol, after previous trials in acute limb ischemia, is a useful treatment during percutaneous coronary intervention. This therapy may delay or even increase mortality, even after a successful stent implantation." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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