Ischemic StrokeTIGERNCT03474549
Treatment With Intent to Generate Endovascular Reperfusion
A study testing Tigertriever revascularization device in people with Ischemic Stroke, run by Rapid Medical at 17 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Tigertriever revascularization device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 17 sitesin 2 countries
- Study dates
- 9 May 2018to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- New focal neurologic deficit consistent with being of acute cerebral ischemia origin.
- Age 18-85 years old (inclusive).
- Interventionalist estimates that treatment with the Tigertriever (first deployment in target vessel) can be achieved within 8 hours of symptom onset.
- 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.
- NIH Stroke Scale score of 8-29.
- No known significant pre-stroke disability (prestroke mRS 0 or 1).
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- 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.
- For strokes in the anterior circulation, the following imaging criteria should also be met:
- MRI criterion: volume of diffusion restriction visually assessed ≤50 mL, OR
- CT criterion: ASPECTS 6 to 10 on baseline NCCT or CTA-source images,
- 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.
- Anticipated life expectancy of at least 6 months.
- A signed informed consent by patient or a Legally Authorized Representative or independent physician in case of oral consent.
Who cannot join
- Subject already participating in another study of an investigational treatment device or treatment.
- Use of any other intra-arterial recanalization drug or device prior to the Tigertriever (Tigertriever not as first choice device).
- Angiographically evident excessive arterial tortuosity precluding device access to the thrombus.
- 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.
- Glucose < 50 mg/dl (2.78 mmol/L) or > 400 mg/dl (22.20 mmol/L).
- Known hemorrhagic diathesis.
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- Coagulation factor deficiency or oral anti-coagulant therapy with an international normalized ratio (INR) of more than 3.0.
- Treatment with heparin within 48 h with a partial thromboplastin time more than two times the laboratory normal.
- 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.
- Platelet count of less than 50,000/uL.
- History of severe allergy to contrast medium, nickel, or Nitinol.
- Intracranial hemorrhage.
- Significant mass effect with midline shift.
- Intracranial tumor (apart from small meningioma, ≤ 2 cm in diameter).
- 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).
- Females who are pregnant or breastfeeding.
- Known current use of cocaine at time of treatment.
- Prior recent stroke in the past 3 months.
- Renal failure with serum creatinine >3.0 or Glomerular Filtration Rate (GFR) <30.
- Known cerebral vasculitis.
- Rapidly improving neurological status defined as improvement of greater than 8 points on the NIHSS or improvement to NIHSS of < 6 prior to procedure
- Clinical symptoms suggestive of bilateral stroke or stroke in multiple territories.
- Ongoing seizure due to stroke.
- Evidence of active systemic infection.
- Known cancer with metastases.
- Suspicion of aortic dissection, septic embolus, or bacterial endocarditis.
- Evidence of dissection in the extra or intracranial cerebral arteries.
- Occlusions in multiple vascular territories (e.g., bilateral anterior circulation, or anterior/posterior circulation).
- Aneurysm in target vessel.
Trial locations and contacts
17 sites in 2 countries.
17 sites in 2 countries
United States16 sites
Maimonides Medical Center
Brooklyn, New York, 11219
University of Buffalo
Buffalo, New York, 14203
Riverside Methodist Hospital
Columbus, Ohio, 43214
Tenet Health
Coral Springs, Florida, 33076
VBMC Harlingen
Harlingen, Texas, 78550
University of Iowa
Iowa City, Iowa, 52242
Baptist Health Research Institute
Jacksonville, Florida, 32207
UCLA medical center
Los Angeles, California, 90095
WellStar Research Institute
Marietta, Georgia, 30060
Baptist Health South Florida
Miami, Florida, 33176
University of Miami
Miami, Florida, 33316
UPMC
Pittsburgh, Pennsylvania, 15213
Oregon Health & Science University
Portland, Oregon, 97239
Los Robles
Thousand Oaks, California, 91360
Mercy Health
Toledo, Ohio, 43604
University of Massachusetts
Worcester, Massachusetts, 01655
About this study
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.
- Conditions
- Ischemic Stroke
- Being tested
- Tigertriever revascularization device
- Keywords
- Mechanical thrombectomy,, Brain, Brain clot, Brain infarction, Cerebral ischemia, Neurovascular intervention, Revascularization, Reperfusion, Stent retriever, Tigertriever, Stroke, Rapid Medical
- Medical subject headings
- Ischemic Stroke, Brain Infarction, Brain Ischemia, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tigertriever revascularization deviceDevice
Mechanical Thrombectomy
| Study group | Role | What they receive |
|---|---|---|
| Tigertriever revascularization device | Experimental | Mechanical thrombectomy with Tigertriever Receives: Device: Tigertriever revascularization device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful Reperfusion, Defined as mTICI Score ≥ 2b
Effectiveness (Successful reperfusion)
Measured: Day 0 (end of procedure)
All-cause Mortality
Safety (All-cause mortality)
Measured: 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.
Measured: 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.
Measured: 90 days post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2018
- Study start9 May 2018
- Primary completion15 Apr 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rapid Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeffrey L Saver, Dr., Principal investigator, Geffen School of Medicine at UCLARishi Gupta, Dr., Principal investigator, WellStar Medical Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03474549
- Sponsor's protocol ID
- CLN-TI-001
- Acronym
- TIGER
- Status last verified
- Jul 2020
- First submitted
- 6 Mar 2018
- Last updated
- 8 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
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.
PubMed 33739136
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment With Intent to Generate Endovascular Reperfusion
- ClinicalTrials.gov ID
- NCT03474549
- Acronym / sponsor ID
- TIGER / CLN-TI-001
- Conditions
- Ischemic Stroke
- Keywords
- Mechanical thrombectomy,, Brain, Brain clot, Brain infarction, Cerebral ischemia, Neurovascular intervention, Revascularization, Reperfusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Rapid MedicalIndustry (pharma, biotech, devices)
- Study start
- 9 May 2018 (actual)
- Primary completion
- 15 Apr 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 22 Mar 2018 (actual)
- Results
- Posted 8 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tigertriever revascularization device | Experimental | Device: Tigertriever revascularization deviceMechanical thrombectomy with Tigertriever |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- New focal neurologic deficit consistent with being of acute cerebral ischemia origin.
- Age 18-85 years old (inclusive).
- Interventionalist estimates that treatment with the Tigertriever (first deployment in target vessel) can be achieved within 8 hours of symptom onset.
- 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.
- NIH Stroke Scale score of 8-29.
Key exclusion criteria (29 listed)
- Subject already participating in another study of an investigational treatment device or treatment.
- Use of any other intra-arterial recanalization drug or device prior to the Tigertriever (Tigertriever not as first choice device).
- Angiographically evident excessive arterial tortuosity precluding device access to the thrombus.
- 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.
- Glucose < 50 mg/dl (2.78 mmol/L) or > 400 mg/dl (22.20 mmol/L).
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 revascularization deviceMechanical Thrombectomy | Device | Tigertriever revascularization device |
Primary outcome
Successful Reperfusion, Defined as mTICI Score ≥ 2b
Time frame: Day 0 (end of procedure)
Effectiveness (Successful reperfusion)
All-cause Mortality
Time frame: 90 days post treatment
Safety (All-cause mortality)
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
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.
1 secondary outcome
Modified Rankin Scale (mRS) Score of ≤2
Time frame: 90 days post treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33739136Gupta 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.
- 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.
Jeffrey L Saver, Dr. principal investigator
Geffen School of Medicine at UCLA
Rishi Gupta, Dr. principal investigator
WellStar Medical Group
17 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tigertriever revascularization device in people with Ischemic Stroke, run by Rapid Medical at 17 sites in 2 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 13 inclusion and 29 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 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States, Israel. 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?
Yes. Results are posted in the registry (first posted 8 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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, Defined as mTICI Score ≥ 2b (time frame: Day 0 (end of procedure)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03474549, which also lists 1 linked publication.
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 8 May 2024.