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Stentriever
Adjustable Low-profile Stentriever for Ischemic Stroke (DISTALS Trial)
N/A
Recruiting
Research Sponsored by Rapid Medical
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Pre-stroke mRS ≤2
Disabling presenting deficits that localize to the territory of the distal vessel occlusion. Disabling deficits are deficits that, if unchanged, would prevent the subject from performing basic activities of daily living (i.e., bathing, ambulating, toileting, hygiene, and eating) or returning to work
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24±6 hours of randomization.
Awards & highlights
DISTALS Trial Summary
This trial is testing a new device to see if it is safe and effective at restoring blood flow in the neurovasculature for people who have had a stroke with disabling neurological deficits due to a primary distal vessel occlusion.
Who is the study for?
This trial is for adults aged 18-85 with a recent ischemic stroke causing significant disability, who can't receive standard clot-dissolving drugs. They must have had symptoms start within the last 24 hours and not be pregnant or breastfeeding. Participants need to have certain levels of stroke severity and brain imaging findings, but cannot join if they've had another stroke treatment first or have conditions like severe allergies to metals used in the device.Check my eligibility
What is being tested?
The DISTALS Study tests the Tigertriever 13 Device's ability to remove blood clots from smaller brain vessels in patients with disabling strokes compared to usual medical care. The goal is to see if this new device can improve blood flow better than current treatments when started within a day of symptom onset.See study design
What are the potential side effects?
Potential side effects may include risks associated with inserting the device into blood vessels such as bleeding, additional blockages caused by dislodged clots, vessel damage, allergic reactions to materials in the device, and possible interactions with other medications.
DISTALS Trial 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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I have severe symptoms from a stroke that stop me from doing daily tasks or working.
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I have a brain lesion larger than 10 cc in specific areas.
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I cannot receive clot-dissolving medication within 3 hours of my stroke.
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I can start the study treatment within 24 hours of my last stroke symptom-free moment.
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I am between 18 and 85 years old.
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I have severe symptoms from a stroke that stop me from doing daily tasks or working.
DISTALS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24±6 hours post procedure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24±6 hours post procedure
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Successful reperfusion (CTP or MR PWI*) without sICH**.
Secondary outcome measures
All cause mortality at 90 days.
Any asymptomatic intracranial hemorrhage within 24±6 hours of randomization.
Device/procedure related serious adverse events (SAEs).
+8 moreDISTALS Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: TreatmentExperimental Treatment1 Intervention
Mechanical thrombectomy with Tigertriever 13 EVT + MM (without thrombolysis).
Group II: ControlActive Control1 Intervention
Medical Management alone (without thrombolysis).
Find a Location
Who is running the clinical trial?
Rapid MedicalLead Sponsor
6 Previous Clinical Trials
1,221 Total Patients Enrolled
4 Trials studying Ischemic Stroke
707 Patients Enrolled for Ischemic Stroke
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I was mostly independent before my stroke.I have taken a blood thinner pill in the last 2 days.I do not have a brain tumor larger than 2 cm, except for a small meningioma.I currently have an infection that affects my whole body.Your platelet count is lower than 50,000 per microliter.You have had a serious allergic reaction to contrast medium, nickel, or Nitinol in the past.My cancer has spread to other parts of my body.I've been treated with heparin recently and my blood clotting time is high.There are signs of a tear in the arteries of your brain.I might have a serious heart or blood vessel infection.You have signs of recent bleeding in your brain on a CT or MRI at the time of admission.You have a score between 4 and 24 on the NIH Stroke Scale, or a score between 2 and 24 if you have trouble speaking or seeing.My kidney function is severely impaired.My blood does not clot properly due to a condition or medication, with an INR over 1.7.I have a brain lesion larger than 10 cc in specific areas.I cannot receive clot-dissolving medication within 3 hours of my stroke.I can start the study treatment within 24 hours of my last stroke symptom-free moment.I have severe symptoms from a stroke that stop me from doing daily tasks or working.I haven't used any other device in my arteries before the Tigertriever 13.You have a specific type of brain damage in less than half of the affected area.I am experiencing seizures caused by a stroke.I am between 18 and 85 years old.I have severe, ongoing high blood pressure above 220/120.Your blood sugar levels are too low (less than 50 mg/dl) or too high (more than 400 mg/dl).There is blockage in specific blood vessels in your neck or brain.I had a blockage in a smaller vessel during a procedure to remove a clot in a larger brain vessel.I have severe symptoms from a stroke that stop me from doing daily tasks or working.I have not had a stroke in the last 3 months.You are currently using cocaine.I have or might have inflammation of blood vessels in my brain.Your blood vessels are too twisted or narrowed, making it difficult to place a small catheter in the right spot.Your small blood vessels are blocked and measure at least 1.5 millimeters in diameter on a special imaging test.I have had a stroke affecting both sides of my brain or in multiple areas.I have a bleeding disorder.I have an aneurysm in a major blood vessel.I am not pregnant or breastfeeding.
Research Study Groups:
This trial has the following groups:- Group 1: Control
- Group 2: Treatment
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.
Ischemic Stroke Patient Testimony for trial: Trial Name: NCT05152524 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this experiment have an age limit, and if so, is it above 55 years old?
"This clinical trial is accepting applications from adults aged 18 or above and below 85 years of age."
Answered by AI
Might I be eligible to volunteer for this experiment?
"This research trial is seeking 168 individuals aged 18-85 who have suffered a wake-up stroke and meet the prerequisites listed here: Age between 18 years and 85 years old, Preceding mRS ≤2, Impedimental symptoms that localize to a distal vessel occlusion territory (which would impede everyday activities such as bathing, eating etc. or returning to work), NIHSS 4-24/NIHSS 2-24 in cases of aphasia/hemianopia , Perfusion lesion Tmax >4.0 seconds volume ≥10 cc on CTP or MR PWI within ACA segments,"
Answered by AI
Is this medical experiment currently open to participants?
"The research posted on clinicaltrials.gov shows that this study is currently looking for applicants, with the original post date of March 25th 2022 and last updated July 5th 2022."
Answered by AI
How many participants have been approved to partake in this experiment?
"168 patients that meet the predetermined eligibility requirements are required to partake in this clinical study. Patients can take part from WellStar Research Institute in Marietta, Georgia and Los Robles in Thousand Oaks, California among other designated sites."
Answered by AI
In how many distinct sites is this research being conducted?
"This trial is conducted across 4 medical sites, such as WellStar Research Institute in Marietta, Los Robles in Thousand Oaks and University of Buffalo in Buffalo. Additionally, there are another 4 locations facilitating the study."
Answered by AI
Who else is applying?
What state do they live in?
Tennessee
Ontario
What site did they apply to?
University of Buffalo
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1
Why did patients apply to this trial?
His sounds are clear but they don't make words. i.e. he's not moaning or slurring etc. If you met him, you'd get excited about helping him get his speech back. He was such a quick wit and clever punster.
PatientReceived 2+ prior treatments
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