Distal Ischemic Stroke Treatment With Adjustable Low-profile Stentriever

NCT05152524 | Active Not Recruiting FDA Device

• 1 other identifier: CLN-TR13-001
• Study Type: interventional
• Target: 168
• Locations: 4 countries
• Sites: 20

Brief Summary

The objective of the DISTALS Study is to evaluate the safety and effectiveness of the Tigertriever 13 Revascularization Device in restoring blood flow in the neurovasculature by removing thrombus in patients presenting within 24 hours of onset with an ischemic stroke with disabling neurological deficits due to a primary distal vessel occlusion (DVO), as compared to medical management.

Conditions

Ischemic Stroke; Neovascularization

Outcome Measures

Primary Outcomes (1)

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

  \*Successful reperfusion is defined as \>50% reduction in substantial hypoperfusion (Tmax \>4 seconds) volume between baseline and 24 ±6 hours of randomization. \*\*sICH shall be defined as any parenchymal hematoma type 2, remote intracerebral hemorrhage, subarachnoid hemorrhage, or intraventricular hemorrhage that is the predominant cause of ≥4 point NIHSS deterioration at 24 ±6 hours of randomization.

  24±6 Hours post randomization

Secondary Outcomes (11)

• All cause mortality at 90 days.

  90 days post randomization.

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

  24±6 hours of randomization.

• Device/procedure related serious adverse events (SAEs).

  90 days post randomization.

• Unanticipated adverse device effect (UADEs).

  During procedure

• Volume of penumbral tissue salvaged at 24±6 hours of randomization (CTP or MR DWI/PWI).

  24±6 hours post randomization.

Study Arms (2)

Treatment

EXPERIMENTAL

Mechanical thrombectomy with Tigertriever 13 EVT + MM (without thrombolysis).

Device: Tigertriever 13

Control

NO INTERVENTION

Medical Management alone (without thrombolysis).

Interventions

Tigertriever 13 DEVICE

patients presenting within 24 hours of onset with an ischemic stroke with disabling neurological deficits due to a primary distal vessel occlusion (DVO) will be treated with the Tigertriever 13 device.

Treatment

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-85 years old.
• 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.
• NIHSS 4-24, or NIHSS 2-24 for patients with aphasia and/or hemianopia.
• Perfusion lesion (Tmax \>4.0 seconds) volume ≥10 cc on CTP or MR PWI within the territory of the anterior cerebral artery (ACA) segments, a non-dominant or co-dominant M2 middle cerebral artery (MCA) segment, an M3 MCA, or the posterior cerebral artery (PCA) segments.
• Occluded distal vessel diameter ≥1.5 mm as measured on CTA or MRA.
• Ischemic core lesion (rCBF\<30% on CTP or ADC \<620 on MR DWI) in ≤50% of the perfusion lesion volume.
• Study treatment can be initiated within 24 hours of last known well time (last known time without current stroke symptoms).
• Signed informed consent by patient or legally authorized representative.
• Subject is not eligible for intravenous thrombolysis within 3 hours from stroke onset per FDA label and American Heart Association/American Stroke Association national guidelines. (Note: administration of intravenous thrombolytics should not be avoided or delayed in order to achieve participation in this study.)

You may not qualify if:

• Evidence of acute brain hemorrhage on CT and/or MRI at admission.
• Use of any other intra-arterial (IA) recanalization device prior to the Tigertriever 13 in the target vessel, including aspiration catheter.
• The DVO is a secondary distal occlusion that occurred during a large vessel occlusion (LVO) thrombectomy procedure.
• Excessive tortuosity or stenosis that is anticipated to prevent placement of the microcatheter in the target vessel. Tortuosity or stenosis will be determined on CTA or MRA prior to randomization.
• Evidence of tandem occlusion in the cervical internal carotid artery (ICA), intracranial ICA, M1 MCA, dominant M2 MCA, vertebral artery (VA) or basilar artery (BA) on CTA or MRA.
• Evidence of dissection in the extra or intracranial cerebral arteries.
• Evidence of bilateral acute stroke or acute stroke in multiple territories (e.g., bilateral anterior circulation, anterior/posterior circulation).
• Prior stroke in the last 3 months.
• Anticipated inability to obtain 3-month follow-up assessments.
• Females who are pregnant or breastfeeding.
• Renal failure with serum creatinine \>3.0 or Glomerular Filtration Rate (GFR) \<30.
• Pre-procedural severe sustained hypertension with SBP \>220 and/or DBP \>120.
• Pre-procedural glucose \<50 mg/dl (2.78 mmol/L) or \>400 mg/dl (22.20 mmol/L).
• Pre-procedural coagulation factor deficiency or oral anti-coagulant therapy with an international normalized ratio (INR) of more than 1.7.
• Treatment with heparin within 48 hours with a partial thromboplastin time more than two times the laboratory normal.

Sponsors & Collaborators

• Rapid Medical: lead

Study Sites (20)

Lakewood Regional Medical Center

Los Angeles, California, 90013, United States

Location

Los Robles

Thousand Oaks, California, 91360, United States

Location

WellStar Research Institute

Marietta, Georgia, 30060, United States

Location

Advocate Aurora Research Institute,

Chicago, Illinois, 60657, United States

Location

Corewell Health (Spectrum)

Grand Rapids, Michigan, 49085, United States

Location

Munson Medical Center

Traverse City, Michigan, 49684, United States

Location

University of Buffalo

Buffalo, New York, 14203, United States

Location

NYU Langone Health

New York, New York, 10016, United States

Location

Mount Sinai

New York, New York, 10029, United States

Location

Stony Brook University

Stony Brook, New York, 11794, United States

Location

Mercy Health

Toledo, Ohio, 43604, United States

Location

Semmes Murphey Foundation

Memphis, Tennessee, 38120, United States

Location

Valley Baptist Medical Center

Harlingen, Texas, 78550, United States

Location

Texas Stroke Institute

Plano, Texas, 75075, United States

Location

CUB Hôpital Erasme

Brussels, 1070, Belgium

Location

Universitätsklinikum Bonn

Bonn, 53127, Germany

Location

Alfreid Krupp

Essen, Germany

Location

Universitätsklinikum Schleswig-Holstein

Kiel, Germany

Location

St. Lukas hospital, Radprax

Solingen, 42697, Germany

Location

Orebro University Hospital

Örebro, Sweden

Location

MeSH Terms

Conditions

Ischemic Stroke; Neovascularization, Pathologic

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2021
• First Posted: December 10, 2021
• Study Start: March 25, 2022
• Primary Completion: December 1, 2025
• Study Completion: March 1, 2026
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1); DE (4); US (14); BE (1)