Distal Ischemic Stroke Treatment With Adjustable Low-profile Stentriever (DISTALS)

April 18, 2024 updated by: Rapid Medical
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

168

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Belgium
      • Brussels, Belgium, 1070
        • Recruiting
        • CUB Hôpital Erasme
        • Principal Investigator:
          • Noémie Ligot, MD
        • Contact:
          • Nick Alaerts, SN
        • Sub-Investigator:
          • Adrien Guenego, MD
  • Germany
      • Bochum, Germany, 44892
        • Withdrawn
        • University Hospital Knappschaftskrankenhaus
      • Essen, Germany
        • Recruiting
        • Alfreid Krupp
        • Principal Investigator:
          • Rene Chapot, MD
      • Kiel, Germany
        • Recruiting
        • Universitatsklinikum Schleswig-Holstein
        • Principal Investigator:
          • Olav Jansen, MD
      • Solingen, Germany, 42697
        • Recruiting
        • St. Lukas hospital, Radprax
        • Contact:
          • Vera Theresa Strzoda, SN
        • Principal Investigator:
          • Hannes Nordmeyer, MD
  • Sweden
      • Orebro, Sweden
        • Recruiting
        • Orebro University Hospital
        • Principal Investigator:
          • Alex Szolics, MD
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85027
      • Tucson, Arizona, United States, 85711
        • Recruiting
        • Carondelet St. Jospeh's Hospital
        • Contact:
        • Principal Investigator:
          • Alexander Coon, MD
    • California
      • Fullerton, California, United States, 92835
        • Recruiting
        • Providence Health
        • Principal Investigator:
          • Radoslav Raychev, MD
        • Contact:
      • Los Angeles, California, United States, 90013
        • Recruiting
        • Lakewood Regional Medical Center
        • Principal Investigator:
          • Radoslav Raychev, MD
      • Thousand Oaks, California, United States, 91360
        • Recruiting
        • Los Robles
        • Contact:
        • Principal Investigator:
          • Muhammad Asif Taqi
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Recruiting
        • WellStar Research Institute
        • Principal Investigator:
          • Rishi Gupta, MD
        • Contact:
          • Marianne Bain, RN
        • Sub-Investigator:
          • Ahmad Khaldy, MD
    • Michigan
      • Grand Rapids, Michigan, United States, 49085
        • Recruiting
        • Corewell Health (Spectrum)
        • Principal Investigator:
          • Justin Singer, MD
      • Traverse City, Michigan, United States, 49684
        • Recruiting
        • Munson Medical Center
        • Principal Investigator:
          • David Rosenbaum, MD
    • New York
      • Buffalo, New York, United States, 14203
        • Recruiting
        • University of Buffalo
        • Principal Investigator:
          • Kenneth Snyder, MD
        • Contact:
        • Sub-Investigator:
          • Elad Levy, MD
        • Sub-Investigator:
          • Adnan Siddiqui, MD
        • Sub-Investigator:
          • Jason Davis, MD
      • New York, New York, United States, 10016
      • New York, New York, United States, 10029
      • Stony Brook, New York, United States, 11794
    • Ohio
      • Toledo, Ohio, United States, 43604
        • Recruiting
        • Mercy Health
        • Principal Investigator:
          • Osama Zaidat, MD
        • Contact:
          • Ronda White, RN
        • Sub-Investigator:
          • Eigine Lin, MD
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
    • Texas
      • Harlingen, Texas, United States, 78550
      • Plano, Texas, United States, 75075
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53233,
        • Recruiting
        • Advocate Aurora Research Institute,
        • Principal Investigator:
          • Demetrius Lopes, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age 18-85 years old.
  2. Pre-stroke mRS ≤2.
  3. 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.
  4. NIHSS 4-24, or NIHSS 2-24 for patients with aphasia and/or hemianopia.
  5. 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.
  6. Occluded distal vessel diameter ≥1.5 mm as measured on CTA or MRA.
  7. Ischemic core lesion (rCBF<30% on CTP or ADC <620 on MR DWI) in ≤50% of the perfusion lesion volume.
  8. Study treatment can be initiated within 24 hours of last known well time (last known time without current stroke symptoms).
  9. Signed informed consent by patient or legally authorized representative.
  10. 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.)

Exclusion Criteria:

  1. Evidence of acute brain hemorrhage on CT and/or MRI at admission.
  2. Use of any other intra-arterial (IA) recanalization device prior to the Tigertriever 13 in the target vessel, including aspiration catheter.
  3. The DVO is a secondary distal occlusion that occurred during a large vessel occlusion (LVO) thrombectomy procedure.
  4. 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.
  5. 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.
  6. Evidence of dissection in the extra or intracranial cerebral arteries.
  7. Evidence of bilateral acute stroke or acute stroke in multiple territories (e.g., bilateral anterior circulation, anterior/posterior circulation).
  8. Prior stroke in the last 3 months.
  9. Anticipated inability to obtain 3-month follow-up assessments.
  10. Females who are pregnant or breastfeeding.
  11. Renal failure with serum creatinine >3.0 or Glomerular Filtration Rate (GFR) <30.
  12. Pre-procedural severe sustained hypertension with SBP >220 and/or DBP >120.
  13. Pre-procedural glucose <50 mg/dl (2.78 mmol/L) or >400 mg/dl (22.20 mmol/L).
  14. Pre-procedural coagulation factor deficiency or oral anti-coagulant therapy with an international normalized ratio (INR) of more than 1.7.
  15. Treatment with heparin within 48 hours with a partial thromboplastin time more than two times the laboratory normal.
  16. Treatment with a direct oral anticoagulant (DOAC) within 48 hours.
  17. Platelet count of less than 50,000/uL.
  18. History of severe allergy to contrast medium, nickel, or Nitinol.
  19. Known current use of cocaine at time of treatment.
  20. Known or suspected cerebral vasculitis.
  21. Known hemorrhagic diathesis.
  22. Aneurysm in target vessel.
  23. Intracranial tumor (apart from small meningioma, ≤2 cm in diameter).
  24. Ongoing seizure due to stroke.
  25. Evidence of active systemic infection.
  26. Known cancer with metastases.
  27. Suspicion of aortic dissection, septic embolus, or bacterial endocarditis.
  28. Subject already participating in another study of an investigational treatment device or treatment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
Mechanical thrombectomy with Tigertriever 13 EVT + MM (without thrombolysis).
Device: Tigertriever 13
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.
No Intervention: Control
Medical Management alone (without thrombolysis).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Successful reperfusion (CTP or MR PWI*) without sICH**.
Time Frame: 24±6 Hours post randomization

*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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
All cause mortality at 90 days.
Time Frame: 90 days post randomization.
All cause mortality at 90 days.
90 days post randomization.
Any asymptomatic intracranial hemorrhage within 24±6 hours of randomization.
Time Frame: 24±6 hours of randomization.
Any asymptomatic intracranial hemorrhage within 24±6 hours of randomization.
24±6 hours of randomization.
Device/procedure related serious adverse events (SAEs).
Time Frame: 90 days post randomization.
Device/procedure related serious adverse events (SAEs).
90 days post randomization.
Unanticipated adverse device effect (UADEs).
Time Frame: During procedure
Unanticipated adverse device effect (UADEs).
During procedure
Volume of penumbral tissue salvaged at 24±6 hours of randomization (CTP or MR DWI/PWI).
Time Frame: 24±6 hours post randomization.
Volume of penumbral tissue salvaged at 24 ±6 hours of randomization (CTP or MR DWI/PWI).
24±6 hours post randomization.
Successful reperfusion at 24 hours, defined as >50% reduction in substantial hypoperfusion (Tmax >4 seconds) volume between baseline and 24 ±6 hours of randomization (assessed in both Treatment and Control arms).
Time Frame: 24±6 hours post randomization
Successful reperfusion at 24 hours, defined as >50% reduction in substantial hypoperfusion (Tmax >4 seconds) volume between baseline and 24 ±6 hours of randomization (assessed in both Treatment and Control arms).
24±6 hours post randomization
Successful reperfusion (eTICI ≥2b50) rate in the distal occluded vessel after Tigertriever 13 mechanical thrombectomy (assessed in Treatment arm only).
Time Frame: 24±6 hours Post procedure
Successful reperfusion (eTICI ≥2b50) rate in the distal occluded vessel after Tigertriever 13 mechanical thrombectomy (assessed in Treatment arm only).
24±6 hours Post procedure
modified Rankin Scale (mRS) score
Time Frame: 90 days post randomization
Level of global disability at 90 days measured by the modified Rankin Scale (mRS) shift (tetrachotomized: 0, 1, 2, 3-6). Minimum score: 0; Maximum score: 6. Lower scores reflects a better clinical outcome, and higher scores reflects worse clinical outcome.
90 days post randomization
National Institutes of Health Stroke Scale (NIHSS) shift
Time Frame: 4 days post procedure
NIHSS change from Baseline to Day 4. Minimum score: 0; Maximum score: 42. Lower scores reflects a better clinical outcome, and higher scores reflects worse clinical outcome.
4 days post procedure
EQ-5D score
Time Frame: 90 days post randomization
Health-related quality of life at 90 days - EQ-5D. Minimum score: 1; Maximum score: 9. Lower scores reflects a better clinical outcome, and higher scores reflects worse clinical outcome.
90 days post randomization
MoCA: Montreal Cognitive Assessment
Time Frame: 90 days post randomization
Cognitive function at 90 days. Minimum score: 0; Maximum score: 30. Higher scores reflects a better clinical outcome, and Lower scores reflects worse clinical outcome.
90 days post randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rapid Medical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 25, 2022

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

August 1, 2024

Study Registration Dates

First Submitted

September 26, 2021

First Submitted That Met QC Criteria

November 28, 2021

First Posted (Actual)

December 10, 2021

Study Record Updates

Last Update Posted (Actual)

April 19, 2024

Last Update Submitted That Met QC Criteria

April 18, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLN-TR13-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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