What side effects are associated with this type of intervention?

Mechanical thrombectomy, a common treatment for ischemic stroke, can have side effects such as bleeding at the puncture site, intracranial hemorrhage, vessel perforation, and arterial reocclusion. Other potential complications include infection, contrast-induced nephropathy, and allergic reactions to contrast dye. These side effects are generally rare but can be serious, requiring careful patient selection and monitoring.

What prior FDA approvals exist?

The FDA has approved several devices for mechanical thrombectomy in the treatment of ischemic stroke, which aim to restore blood flow by removing the thrombus. Notable devices include the Solitaire FR Revascularization Device and the Trevo ProVue Retriever. These devices are used in patients presenting with large vessel occlusions and have shown effectiveness in improving clinical outcomes when used within a specific time window from stroke onset. The Tigertriever 13 Revascularization Device, currently under study, is another mechanical thrombectomy device designed to treat distal vessel occlusions, potentially expanding the treatment options for ischemic stroke patients.

What other types of research exist?

Promising novel alternatives to the Tigertriever 13 Revascularization Device for ischemic stroke patients in 2024 include: 1) The EmboTrap II Revascularization Device, which has shown high efficacy in clot retrieval and rapid revascularization. 2) The Solitaire X Revascularization Device, known for its advanced stent retriever technology and improved patient outcomes. 3) The Trevo NXT ProVue Retriever, which offers enhanced visibility and control during thrombectomy procedures. These devices are part of the latest generation of mechanical thrombectomy tools designed to improve success rates and patient recovery.

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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

Must not have

Treatment with a direct oral anticoagulant (DOAC) within 48 hours

Evidence of active systemic infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24±6 hours of randomization.

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new device that removes blood clots from brain vessels in stroke patients with severe symptoms. The goal is to see if it works better than current methods.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have taken a blood thinner pill in the last 2 days.

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I currently have an infection that affects my whole body.

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My cancer has spread to other parts of my body.

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I've been treated with heparin recently and my blood clotting time is high.

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I might have a serious heart or blood vessel infection.

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My kidney function is severely impaired.

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My blood does not clot properly due to a condition or medication, with an INR over 1.7.

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I haven't used any other device in my arteries before the Tigertriever 13.

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I am experiencing seizures caused by a stroke.

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I have severe, ongoing high blood pressure above 220/120.

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I had a blockage in a smaller vessel during a procedure to remove a clot in a larger brain vessel.

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I have not had a stroke in the last 3 months.

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I have or might have inflammation of blood vessels in my brain.

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I have had a stroke affecting both sides of my brain or in multiple areas.

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I have a bleeding disorder.

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I have an aneurysm in a major blood vessel.

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I am not pregnant or breastfeeding.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24±6 hours post procedure for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Successful reperfusion (CTP or MR PWI*) without sICH**.

Secondary study objectives

All cause mortality at 90 days.

Any asymptomatic intracranial hemorrhage within 24±6 hours of randomization.

Device/procedure related serious adverse events (SAEs).

+8 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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).

0 / 24Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Mechanical thrombectomy, such as the use of the Tigertriever 13 Revascularization Device, involves the physical removal of a blood clot from a blocked artery in the brain. This procedure is performed using a specialized device that is navigated through the blood vessels to the site of the clot, where it captures and extracts the thrombus, thereby restoring blood flow. This treatment is crucial for ischemic stroke patients as it can significantly reduce the extent of brain damage, improve functional outcomes, and increase the chances of recovery when performed promptly after stroke onset.