ClinicalTrials.gg
CompletedNCT03474549TIGERUpdated May 8, 2024Results posted

Treatment With Intent to Generate Endovascular Reperfusion

An interventional study of Tigertriever revascularization device in Ischemic Stroke, sponsored by Rapid Medical. Completed at 17 sites in 2 countries. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-05-08.

Sponsored by Rapid Medical · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
160
Allocation
Not applicable
Ages
18 Years to 85 Years
Sex
All
01

Study summary

Tigertriever is a CE marked mechanical revascularization device indicated to restore blood flow by removing thrombus from a large intracranial vessel in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for IV t-PA or who fail IV t-PA therapy are candidates for treatment.

The objective of the TIGER Study is to evaluate the safety and effectiveness of the Tigertriever device in restoring blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke due to a large vessel occlusion (LVO). This study is designed to support substantial equivalence to approved and marketed products such as the Solitaire or Trevo Retriever.

02

Conditions studied

  • Ischemic Stroke

Keywords

  • Mechanical thrombectomy,
  • Brain
  • Brain clot
  • Brain infarction
  • Cerebral ischemia
  • Neurovascular intervention
  • Revascularization
  • Reperfusion
  • Stent retriever
  • Tigertriever
  • Stroke
  • Rapid Medical
03

In context

Ischemic Stroke

2,612 studies on the registry are indexed under Ischemic Stroke; 971 are open to participants now.

This study's enrollment of 160 is above the median of 120 across 1,776 interventional studies indexed under Ischemic Stroke.

Browse Ischemic Stroke studies →

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

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.

Inclusion criteria

  1. New focal neurologic deficit consistent with being of acute cerebral ischemia origin.
  2. Age 18-85 years old (inclusive).
  3. Interventionalist estimates that treatment with the Tigertriever (first deployment in target vessel) can be achieved within 8 hours of symptom onset.
  4. Patient either: a) eligible for, and received, IV t-PA within 3 hours of symptom onset, at the correct 0.9 mg/kg dose, or b) ineligible for IV t-PA.
  5. NIH Stroke Scale score of 8-29.
  6. No known significant pre-stroke disability (prestroke mRS 0 or 1).
  7. Catheter angiographic confirmation of a large vessel occlusion in the intracranial internal carotid artery, the M1 or M2 segments of the middle cerebral artery, the intracranial vertebral artery, or the basilar artery that is accessible to Tigertriever device.
  8. For strokes in the anterior circulation, the following imaging criteria should also be met:

    1. MRI criterion: volume of diffusion restriction visually assessed ≤50 mL, OR
    2. CT criterion: ASPECTS 6 to 10 on baseline NCCT or CTA-source images,
  9. For strokes in the posterior circulation, the following imaging criterion should also be met: pcASPECTS score 8 to 10 on baseline NCCT, CTA-source images, or DWI MRI.
  10. Anticipated of at least 6 months.
  11. A signed by patient or a Legally Authorized Representative or independent physician in case of oral consent.

Exclusion criteria

Exclusion Criteria:

  1. Subject already participating in another study of an treatment device or treatment.
  2. Use of any other intra-arterial recanalization drug or device prior to the Tigertriever (Tigertriever not as first choice device).
  3. Angiographically evident excessive arterial tortuosity precluding device access to the thrombus.
  4. For all patients, severe sustained hypertension with SBP >220 and/or DBP >120; for patients treated with IV tPA, sustained hypertension despite treatment with SBP >185 and/or DBP > 110.
  5. Glucose \< 50 mg/dl (2.78 mmol/L) or > 400 mg/dl (22.20 mmol/L).
  6. Known hemorrhagic diathesis.
  7. Coagulation factor deficiency or oral anti-coagulant therapy with an (INR) of more than 3.0.
  8. Treatment with heparin within 48 h with a partial thromboplastin time more than two times the laboratory normal.
  9. Patients who have received a direct thrombin inhibitor within the last 48 hours; must have a partial thromboplastin time (PTT) less than 1.5 times the normal to be eligible.
  10. count of less than 50,000/uL.
  11. History of severe allergy to contrast medium, nickel, or Nitinol.
  12. Intracranial hemorrhage.
  13. Significant mass effect with midline shift.
  14. Intracranial tumor (apart from small meningioma, ≤ 2 cm in diameter).
  15. Stenosis or any occlusion in the deployment site or in a proximal vessel requiring treatment or preventing device access to the thrombus (for example, stenosis or occlusion in the cervical internal carotid artery).
  16. Females who are pregnant or breastfeeding.
  17. Known current use of cocaine at time of treatment.
  18. Prior recent stroke in the past 3 months.
  19. Renal failure with serum creatinine >3.0 or (GFR) \<30.
  20. Known cerebral vasculitis.
  21. Rapidly improving neurological status defined as improvement of greater than 8 points on the NIHSS or improvement to NIHSS of \< 6 prior to procedure
  22. Clinical symptoms suggestive of bilateral stroke or stroke in multiple territories.
  23. Ongoing seizure due to stroke.
  24. Evidence of active systemic infection.
  25. Known cancer with .
  26. Suspicion of aortic dissection, septic embolus, or bacterial endocarditis.
  27. Evidence of dissection in the extra or intracranial cerebral arteries.
  28. Occlusions in multiple vascular territories (e.g., bilateral anterior circulation, or anterior/posterior circulation).
  29. Aneurysm in target vessel.
Terms in these criteria, in plain language(7)

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.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

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.

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.

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.

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.

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.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
160 participants (actual)

Study arms

  • Experimental
    Tigertriever revascularization device

    Mechanical thrombectomy with Tigertriever

    Device: Tigertriever revascularization device

Interventions

  • DeviceTigertriever revascularization device

    Mechanical Thrombectomy

06

What researchers measure

Primary outcomes

  1. Successful Reperfusion, Defined as mTICI Score ≥ 2b

    Effectiveness (Successful reperfusion)

    Time frame: Day 0 (end of procedure)

  2. All-cause Mortality

    Safety (All-cause mortality)

    Time frame: 90 days post treatment

  3. Symptomatic Intracranial Hemorrhage (sICH) 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 Hours

    Safety (Symptomatic intracranial hemorrhage (sICH)) 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 hours.

    Time frame: 24 hours post procedure

Secondary outcomes

  1. Modified Rankin Scale (mRS) Score of ≤2

    modified Ranking Scale is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke. The scale runs from 0-6, running from perfect health without symptoms to death.

    Time frame: 90 days post treatment

07

Results

Posted May 8, 2024

Participant flow

Participant flow — Overall Study
MilestoneTigertriever Revascularization Device
Started160
Completed123
Not completed37
Withdrew: Death31
Withdrew: Lost to follow-up4
Withdrew: Withdrawal by subject2

Outcome measures

PrimarySuccessful Reperfusion, Defined as mTICI Score ≥ 2b

Effectiveness (Successful reperfusion)

Time frame:
Day 0 (end of procedure)
Reported as:
Count of participants · Participants
Successful Reperfusion, Defined as mTICI Score ≥ 2b
ParticipantsTigertriever Revascularization Device
Successful Reperfusion, Defined as mTICI Score ≥ 2b130
PrimaryAll-cause Mortality

Safety (All-cause mortality)

Time frame:
90 days post treatment
Reported as:
Count of participants · Participants
All-cause Mortality
ParticipantsTigertriever Revascularization Device
All-cause Mortality31
PrimarySymptomatic Intracranial Hemorrhage (sICH) 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 Hours

Safety (Symptomatic intracranial hemorrhage (sICH)) 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 hours.

Time frame:
24 hours post procedure
Reported as:
Count of participants · Participants
Symptomatic Intracranial Hemorrhage (sICH) 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 Hours
ParticipantsTigertriever Revascularization Device
Symptomatic Intracranial Hemorrhage (sICH) 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 Hours3
SecondaryModified Rankin Scale (mRS) Score of ≤2

modified Ranking Scale is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke. The scale runs from 0-6, running from perfect health without symptoms to death.

Time frame:
90 days post treatment
Reported as:
Count of participants · Participants
Modified Rankin Scale (mRS) Score of ≤2
ParticipantsTigertriever Revascularization Device
Modified Rankin Scale (mRS) Score of ≤286

Adverse events

Collected over 90 days. Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Tigertriever Revascularization Device31/160 (19.4%)71/160 (44.4%)120/160 (75%)
Most frequent serious events
Showing 10 of 12
Most frequent serious events
EventTigertriever Revascularization Device
Nervous system disordersNervous system disorders17/160
Cardiac disordersCardiac disorders15/160
Vascular disordersVascular disorders12/160
Injury, poisoning and procedural complicationsInjury, poisoning and procedural complications6/160
Infections and infestationsInfections and infestations5/160
Gastrointestinal disordersGastrointestinal disorders4/160
Respiratory, thoracic and mediastinal disordersRespiratory, thoracic and mediastinal disorders4/160
Blood and lymphatic system disordersBlood and lymphatic system disorders3/160
General disorders and administration site conditionsGeneral disorders2/160
Metabolism and nutrition disordersMetabolism and nutrition disorders1/160
Most frequent other events
Showing 10 of 16
Most frequent other events
EventTigertriever Revascularization Device
Cardiac disordersCardiac disorders21/160
Gastrointestinal disordersGastrointestinal disorders18/160
Nervous system disordersNervous system disorders18/160
Blood and lymphatic system disordersBlood and lymphatic system disorders16/160
Vascular disordersVascular disorders9/160
Infections and infestationsInfections and infestations7/160
Metabolism and nutrition disordersMetabolism and nutrition disorders6/160
General disorders and administration site conditionsGeneral disorders5/160
Injury, poisoning and procedural complicationsInjury, poisoning and procedural complications5/160
Musculoskeletal and connective tissue disordersMusculoskeletal and connective tissue disorders5/160

Baseline characteristics

160 subjects enrolled

Age, Continuous
Age, Continuous(years)Tigertriever Revascularization Device
Mean65.5 ± 13.9
Sex: Female, Male
Sex: Female, Male(Participants)Tigertriever Revascularization Device
Female68
Male92
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Tigertriever Revascularization Device
American Indian or Alaska Native0
Asian2
Native Hawaiian or Other Pacific Islander0
Black or African American24
White134
More than one race0
Unknown or Not Reported0
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Study locations

17 sites
  • UCLA medical center
    Los Angeles, California 90095, United States
  • Los Robles
    Thousand Oaks, California 91360, United States
  • Tenet Health
    Coral Springs, Florida 33076, United States
  • Baptist Health Research Institute
    Jacksonville, Florida 32207, United States
  • Baptist Health South Florida
    Miami, Florida 33176, United States
  • University of Miami
    Miami, Florida 33316, United States
  • WellStar Research Institute
    Marietta, Georgia 30060, United States
  • University of Iowa
    Iowa City, Iowa 52242, United States
  • University of Massachusetts
    Worcester, Massachusetts 01655, United States
  • Maimonides Medical Center
    Brooklyn, New York 11219, United States
  • University of Buffalo
    Buffalo, New York 14203, United States
  • Riverside Methodist Hospital
    Columbus, Ohio 43214, United States
  • Mercy Health
    Toledo, Ohio 43604, United States
  • Oregon Health & Science University
    Portland, Oregon 97239, United States
  • UPMC
    Pittsburgh, Pennsylvania 15213, United States
  • VBMC Harlingen
    Harlingen, Texas 78550, United States
  • Rambam
    Haifa, Israel
09

References and documents

Publications

  • Gupta R, Saver JL, Levy E, Zaidat OO, Yavagal D, Liebeskind DS, Khaldi A, Gross B, Lang M, Narayanan S, Jankowitz B, Snyder K, Siddiqui A, Davies J, Lin E, Hassan A, Hanel R, Aghaebrahim A, Kaushal R, Malek A, Mueller-Kronast N, Starke R, Bozorgchami H, Nesbit G, Horikawa M, Priest R, Liu J, Budzik RF, Pema P, Vora N, Taqi MA, Samaniego E, Wang QT, Nossek E, Dabus G, Linfante I, Puri A, Abergel E, Starkman S, Tateshima S, Jadhav AP; TIGER Trial Investigators. New Class of Radially Adjustable Stentrievers for Acute Ischemic Stroke: Primary Results of the Multicenter TIGER Trial. Stroke. 2021 May;52(5):1534-1544. doi: 10.1161/STROKEAHA.121.034436. Epub 2021 Mar 19. Erratum In: Stroke. 2021 Jun;52(6):e310. doi: 10.1161/STR.0000000000000376. PubMed 33739136 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from May 2018 to primary completion in Apr 2020, 23 months.

Results were first posted in May 2024, 4 years after primary completion.

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 23 months is close to 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.

Registered
Mar 6, 2018
First posted
Mar 22, 2018
StartActual
May 9, 2018
Primary completionActual
Apr 15, 2020
CompletionActual
Jun 30, 2020
Results first posted
May 8, 2024
Last update
May 8, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 8, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03474549
Lead sponsor
Rapid Medical
Responsible party
Sponsor
First posted
Mar 22, 2018
Start date
May 9, 2018
Primary completion
Apr 15, 2020
Completion
Jun 30, 2020
Results posted
May 8, 2024
Last update
May 8, 2024

Study contacts

Jeffrey L Saver, Dr.
principal investigator · Geffen School of Medicine at UCLA
Rishi Gupta, Dr.
principal investigator · WellStar Medical Group

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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