Ischemic StrokeDISTALSNCT05152524
Distal Ischemic Stroke Treatment With Adjustable Low-profile Stentriever
A study testing Tigertriever 13 in people with Ischemic Stroke and Neovascularization, run by Rapid Medical at 20 sites in 4 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Ischemic Stroke, Neovascularization
- What is being tested?
- Tigertriever 13
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 149 participants
- Where
- 20 sitesin 4 countries
- Study dates
- 25 Mar 2022to 30 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.)
Who cannot join
- 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.
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- 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.
- Treatment with a direct oral anticoagulant (DOAC) within 48 hours.
- Platelet count of less than 50,000/uL.
- History of severe allergy to contrast medium, nickel, or Nitinol.
- Known current use of cocaine at time of treatment.
- Known or suspected cerebral vasculitis.
- Known hemorrhagic diathesis.
- Aneurysm in target vessel.
- Intracranial tumor (apart from small meningioma, ≤2 cm in diameter).
- Ongoing seizure due to stroke.
- Evidence of active systemic infection.
- Known cancer with metastases.
- Suspicion of aortic dissection, septic embolus, or bacterial endocarditis.
- Subject already participating in another study of an investigational treatment device or treatment.
Trial locations and contacts
20 sites in 4 countries.
20 sites in 4 countries
United States14 sites
University of Buffalo
Buffalo, New York, 14203
Advocate Aurora Research Institute,
Chicago, Illinois, 60657
Corewell Health (Spectrum)
Grand Rapids, Michigan, 49085
Valley Baptist Medical Center
Harlingen, Texas, 78550
Lakewood Regional Medical Center
Los Angeles, California, 90013
WellStar Research Institute
Marietta, Georgia, 30060
Semmes Murphey Foundation
Memphis, Tennessee, 38120
NYU Langone Health
New York, New York, 10016
Mount Sinai
New York, New York, 10029
Texas Stroke Institute
Plano, Texas, 75075
Stony Brook University
Stony Brook, New York, 11794
Los Robles
Thousand Oaks, California, 91360
Mercy Health
Toledo, Ohio, 43604
Munson Medical Center
Traverse City, Michigan, 49684
Germany4 sites
Universitätsklinikum Bonn
Bonn, 53127
Alfreid Krupp
Essen
Universitätsklinikum Schleswig-Holstein
Kiel
St. Lukas hospital, Radprax
Solingen, Solingen, 42697
About this study
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
- Being tested
- Tigertriever 13
- Medical subject headings
- Ischemic Stroke, Neovascularization, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tigertriever 13Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Mechanical thrombectomy with Tigertriever 13 EVT + MM (without thrombolysis). Receives: Device: Tigertriever 13 |
| Control | No intervention | Medical Management alone (without thrombolysis). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24±6 Hours post randomization
Secondary outcomes (11)
All cause mortality at 90 days.
All cause mortality at 90 days.
Measured: 90 days post randomization.
Any asymptomatic intracranial hemorrhage within 24±6 hours of randomization.
Any asymptomatic intracranial hemorrhage within 24±6 hours of randomization.
Measured: 24±6 hours of randomization.
Device/procedure related serious adverse events (SAEs).
Device/procedure related serious adverse events (SAEs).
Measured: 90 days post randomization.
Unanticipated adverse device effect (UADEs).
Unanticipated adverse device effect (UADEs).
Measured: During procedure
Volume of penumbral tissue salvaged at 24±6 hours of randomization (CTP or MR DWI/PWI).
Volume of penumbral tissue salvaged at 24 ±6 hours of randomization (CTP or MR DWI/PWI).
Measured: 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).
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).
Measured: 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).
Successful reperfusion (eTICI ≥2b50) rate in the distal occluded vessel after Tigertriever 13 mechanical thrombectomy (assessed in Treatment arm only).
Measured: 24±6 hours Post procedure
modified Rankin Scale (mRS) score
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.
Measured: 90 days post randomization
National Institutes of Health Stroke Scale (NIHSS) shift
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.
Measured: 4 days post procedure
EQ-5D score
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.
Measured: 90 days post randomization
MoCA: Montreal Cognitive Assessment
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.
Measured: 90 days post randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2021
- Study start25 Mar 2022
- Primary completion30 Dec 2025
- Study completion30 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rapid Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05152524
- Sponsor's protocol ID
- CLN-TR13-001
- Acronym
- DISTALS
- Status last verified
- Dec 2025
- First submitted
- 26 Sep 2021
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Distal Ischemic Stroke Treatment With Adjustable Low-profile Stentriever
- ClinicalTrials.gov ID
- NCT05152524
- Acronym / sponsor ID
- DISTALS / CLN-TR13-001
- Conditions
- Ischemic Stroke, Neovascularization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- Rapid MedicalIndustry (pharma, biotech, devices)
- Study start
- 25 Mar 2022 (actual)
- Primary completion
- 30 Dec 2025 (actual)
- Study completion
- 30 Mar 2026 (actual)
- First posted
- 10 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: Tigertriever 13Mechanical thrombectomy with Tigertriever 13 EVT + MM (without thrombolysis). |
| Control | No intervention | –Medical Management alone (without thrombolysis). |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (28 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tigertriever 13patients 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. | Device | Treatment |
Primary outcome
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.
11 secondary outcomes
All cause mortality at 90 days.
Time frame: 90 days post randomization.
Any asymptomatic intracranial hemorrhage within 24±6 hours of randomization.
Time frame: 24±6 hours of randomization.
Device/procedure related serious adverse events (SAEs).
Time frame: 90 days post randomization.
Unanticipated adverse device effect (UADEs).
Time frame: 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.
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 (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
modified Rankin Scale (mRS) score
Time frame: 90 days post randomization
National Institutes of Health Stroke Scale (NIHSS) shift
Time frame: 4 days post procedure
EQ-5D score
Time frame: 90 days post randomization
MoCA: Montreal Cognitive Assessment
Time frame: 90 days post randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
20 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tigertriever 13 in people with Ischemic Stroke and Neovascularization, run by Rapid Medical at 20 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States, Germany, Belgium, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful reperfusion (CTP or MR PWI*) without sICH**. (time frame: 24±6 Hours post randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.