An interventional study of Tigertriever 13 in Ischemic Stroke and Neovascularization, sponsored by Rapid Medical. Completed at 20 sites in 4 countries. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-08-12.
Sponsored by Rapid Medical · Not applicable, Interventional, and Treatment
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.
2,612 studies on the registry are indexed under Ischemic Stroke; 971 are open to participants now.
This study's enrollment of 149 is above the median of 120 across 1,776 interventional studies indexed under Ischemic Stroke.
Browse Ischemic Stroke studies →Rapid Medical is the lead sponsor of 6 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Mechanical thrombectomy with Tigertriever 13 EVT + MM (without thrombolysis).
Device: Tigertriever 13
Medical Management alone (without thrombolysis).
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.
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.
Time frame: 24±6 Hours post randomization
All cause mortality at 90 days.
All cause mortality at 90 days.
Time frame: 90 days post randomization.
Any asymptomatic intracranial hemorrhage within 24±6 hours of 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).
Device/procedure related serious adverse events (SAEs).
Time frame: 90 days post randomization.
Unanticipated adverse device effect (UADEs).
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).
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).
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).
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 90 days post randomization
Plan to share: No
No publications or documents are linked to this record.
Ran from Mar 2022 to primary completion in Dec 2025, 45 months.
Of 81 industry-sponsored interventional studies with no phase under Ischemic Stroke, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 46. This study's 45 months is above that.
Counting every sponsor, half of 653 studies reached it within 27 months; a quarter within 14 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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