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
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.
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 →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.
For strokes in the anterior circulation, the following imaging criteria should also be met:
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.
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.
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.
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.
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.
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.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
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.
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.
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.
Mechanical thrombectomy with Tigertriever
Device: Tigertriever revascularization device
Mechanical Thrombectomy
Successful Reperfusion, Defined as mTICI Score ≥ 2b
Effectiveness (Successful reperfusion)
Time frame: Day 0 (end of procedure)
All-cause Mortality
Safety (All-cause mortality)
Time frame: 90 days post treatment
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
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
| Milestone | Tigertriever Revascularization Device |
|---|---|
| Started | 160 |
| Completed | 123 |
| Not completed | 37 |
| Withdrew: Death | 31 |
| Withdrew: Lost to follow-up | 4 |
| Withdrew: Withdrawal by subject | 2 |
Effectiveness (Successful reperfusion)
| Participants | Tigertriever Revascularization Device |
|---|---|
| Successful Reperfusion, Defined as mTICI Score ≥ 2b | 130 |
Safety (All-cause mortality)
| Participants | Tigertriever Revascularization Device |
|---|---|
| All-cause Mortality | 31 |
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.
| Participants | Tigertriever 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 Hours | 3 |
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.
| Participants | Tigertriever Revascularization Device |
|---|---|
| Modified Rankin Scale (mRS) Score of ≤2 | 86 |
Collected over 90 days. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Tigertriever Revascularization Device | 31/160 (19.4%) | 71/160 (44.4%) | 120/160 (75%) |
| Event | Tigertriever Revascularization Device |
|---|---|
| Nervous system disordersNervous system disorders | 17/160 |
| Cardiac disordersCardiac disorders | 15/160 |
| Vascular disordersVascular disorders | 12/160 |
| Injury, poisoning and procedural complicationsInjury, poisoning and procedural complications | 6/160 |
| Infections and infestationsInfections and infestations | 5/160 |
| Gastrointestinal disordersGastrointestinal disorders | 4/160 |
| Respiratory, thoracic and mediastinal disordersRespiratory, thoracic and mediastinal disorders | 4/160 |
| Blood and lymphatic system disordersBlood and lymphatic system disorders | 3/160 |
| General disorders and administration site conditionsGeneral disorders | 2/160 |
| Metabolism and nutrition disordersMetabolism and nutrition disorders | 1/160 |
| Event | Tigertriever Revascularization Device |
|---|---|
| Cardiac disordersCardiac disorders | 21/160 |
| Gastrointestinal disordersGastrointestinal disorders | 18/160 |
| Nervous system disordersNervous system disorders | 18/160 |
| Blood and lymphatic system disordersBlood and lymphatic system disorders | 16/160 |
| Vascular disordersVascular disorders | 9/160 |
| Infections and infestationsInfections and infestations | 7/160 |
| Metabolism and nutrition disordersMetabolism and nutrition disorders | 6/160 |
| General disorders and administration site conditionsGeneral disorders | 5/160 |
| Injury, poisoning and procedural complicationsInjury, poisoning and procedural complications | 5/160 |
| Musculoskeletal and connective tissue disordersMusculoskeletal and connective tissue disorders | 5/160 |
160 subjects enrolled
| Age, Continuous(years) | Tigertriever Revascularization Device |
|---|---|
| Mean | 65.5 ± 13.9 |
| Sex: Female, Male(Participants) | Tigertriever Revascularization Device |
|---|---|
| Female | 68 |
| Male | 92 |
| Race (NIH/OMB)(Participants) | Tigertriever Revascularization Device |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 2 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 24 |
| White | 134 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
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.
This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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