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Aspiration Thrombectomy Device
Medical Reperfusion Device for Stroke
N/A
Waitlist Available
Led By Guilherme Dabus, MD
Research Sponsored by Route 92 Medical, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Pre-stroke modified Rankin Score (mRS) <= 2
Endovascular treatment initiated (defined as time of groin puncture) within 8 hours from time last known well
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 24 hours post-procedure
Awards & highlights
Study Summary
This trial is testing a new medical device to see if it is safe and effective at treating strokes.
Who is the study for?
This trial is for adults over 18 with acute ischemic stroke, showing specific clinical signs and a certain severity level. They must have had a relatively independent lifestyle before the stroke and be within 8 hours from when they were last known well. Pregnant or breastfeeding individuals, those with severe allergies to contrast media, recent strokes, certain blood disorders, or life expectancy less than a year are excluded.Check my eligibility
What is being tested?
The SUMMIT MAX study tests the Route 92 Medical MonoPoint Reperfusion System's safety and effectiveness in removing blood clots from the brain during an acute ischemic stroke through aspiration thrombectomy (suctioning out the clot).See study design
What are the potential side effects?
While not explicitly listed here, potential side effects may include risks associated with catheter-based procedures such as bleeding at the puncture site, infection risk, possible allergic reactions to contrast media used during imaging studies involved in this procedure.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I was mostly independent before my stroke.
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My treatment started within 8 hours after I was last known to be well.
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I am 18 years old or older.
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I am showing signs of a recent stroke.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ during procedure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during procedure
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of all symptomatic intracerebral hemorrhage (sICH)
Proportion of subjects with successful arterial revascularization defined as a modified Thrombolysis in Cerebrovascular Infarction (mTICI) score of 2b or greater
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Route 92 Medical Monopoint Reperfusion SystemExperimental Treatment1 Intervention
Aspiration thrombectomy with the Route 92 Medical HiPoint 88 and HiPoint 70 Reperfusion Catheters as part of the Monopoint Reperfusion System to treat acute ischemic stroke
Group II: Aspiration PredicateActive Control1 Intervention
Aspiration thrombectomy with a predicate aspiration device to treat acute ischemic stroke
Find a Location
Who is running the clinical trial?
Route 92 Medical, Inc.Lead Sponsor
1 Previous Clinical Trials
66 Total Patients Enrolled
Guilherme Dabus, MDPrincipal InvestigatorBaptist Health - Miami
Ajit Puri, MDPrincipal InvestigatorUniversity of Massachusetts, Worcester
2 Previous Clinical Trials
202 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your baseline ASPECTS score is 6 or higher.I am a candidate for a specific clot removal procedure in my brain.My treatment started within 8 hours after I was last known to be well.Your blood sugar level is lower than 50 mg/dL or higher than 400 mg/dL before starting the study.I might have an infection in my heart or blood clot.I have an aneurysm or AVM near my cancer.You have used cocaine or methamphetamine in the last 6 months.You have blockages in multiple blood vessels in your brain, as shown in an angiogram.Doctors have seen signs of blood vessel problems or blockages in your brain.I was mostly independent before my stroke.You have a blockage in a major blood vessel in the brain.I have had a brain bleed in the past.I had a stroke within the last 3 months.You have an abnormal blood vessel in the area where the study treatment will be given.Your platelet count is less than 50,000 per microliter before starting the study.I have a connective tissue disorder like Marfan or Ehlers-Danlos syndrome.My doctor expects I have less than 12 months to live due to a serious illness.My doctor thinks I have no health issues that would interfere with the treatment.I have a known blood clotting disorder.I have symptoms that suggest I might have had strokes in more than one area of my brain.The medical team thinks it's difficult to reach the blood vessels in the brain.I have a bleeding disorder or take blood thinners with INR over 3.0.You recently had a bleeding in your brain shown on a CT scan or MRI. Finding small areas of bleeding is okay.My scans show a brain tumor or significant swelling caused by the tumor.My cancer has spread to other parts of my body.I have been treated with heparin or low molecular weight heparin in the last 48 hours.I am experiencing seizures caused by a stroke.My kidney function is severely impaired.You have signs of a tear in a blood vessel that the study treatment needs to pass through.There is evidence of a tear in the blood vessels in or around the brain.I have a severe blockage in a blood vessel that needs to be crossed.I have severe, uncontrolled high blood pressure.I currently have an infection that affects my whole body.You have signs or suspicion of a tear in the main blood vessel coming out of the heart.I need a procedure to open narrowed arteries.I am 18 years old or older.I am showing signs of a recent stroke.Your NIH Stroke Scale score is 6 or higher before starting the study.If needed, I will receive clot-dissolving medication as per guidelines without delay.
Research Study Groups:
This trial has the following groups:- Group 1: Aspiration Predicate
- Group 2: Route 92 Medical Monopoint Reperfusion System
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who fulfills the criteria for participating in this research experiment?
"In order to qualify for this medical experiment, potential participants must have suffered from a stroke and be between 18-85 years of age. Currently, 220 people are being sought out in total."
Answered by AI
How many study participants are currently receiving treatment?
"This medical study necessitates the recruitment of 220 participants that meet the requirements. Those interested in participating can join at either University of Massachusetts in Worcester, MA or Advocate Aurora Health in Chicago, IL."
Answered by AI
Does this clinical trial have an age cap, and if so, is it over the age of seventy-five?
"For those hoping to participate in this medical research, they must be between the ages of 18 and 85."
Answered by AI
Are there still spots available for this clinical research?
"Affirmative, this clinical trial is actively recruiting patients. It was first made available on December 15th 2021 and the most recent edit to the study's details occurred on November 30th 2022."
Answered by AI
How many US-based medical centers are administering this clinical trial?
"The University of Massachusetts in Worcester, Advocate Aurora Health in Chicago, and the Baptist Health Lexington in Lexington are some examples of institutions running this clinical trial. Furthermore, there are 21 other recruiting sites located throughout America."
Answered by AI
Who else is applying?
What state do they live in?
West Virginia
How old are they?
18 - 65
What site did they apply to?
West Virginia University
What portion of applicants met pre-screening criteria?
Met criteria
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