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Treatment With Intent to Generate Endovascular Reperfusion (TIGER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03474549
Recruitment Status : Completed
First Posted : March 22, 2018
Last Update Posted : July 21, 2020
Sponsor:
Information provided by (Responsible Party):
Rapid Medical

Brief 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.


Condition or disease Intervention/treatment Phase
Ischemic Stroke Device: Tigertriever revascularization device Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment With Intent to Generate Endovascular Reperfusion
Actual Study Start Date : May 9, 2018
Actual Primary Completion Date : April 15, 2020
Actual Study Completion Date : June 30, 2020

Arm Intervention/treatment
Experimental: Tigertriever revascularization device
Mechanical thrombectomy with Tigertriever
Device: Tigertriever revascularization device
Mechanical Thrombectomy




Primary Outcome Measures :
  1. Successful reperfusion, defined as mTICI Score ≥ 2b [ Time Frame: Day 0 (end of procedure) ]
    Effectiveness (Successful reperfusion)

  2. All-cause mortality [ Time Frame: 90 days post treatment ]
    Safety (All-cause mortality)

  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 [ 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.


Secondary Outcome Measures :
  1. modified Rankin Scale (mRS) score of ≤2 [ Time Frame: 90 days post treatment ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 life expectancy of at least 6 months.
  11. A signed informed consent by patient or a Legally Authorized Representative or independent physician in case of oral consent.

Exclusion Criteria:

  1. Subject already participating in another study of an investigational 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 international normalized ratio (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. Platelet 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 Glomerular Filtration Rate (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 metastases.
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03474549


Locations
Show Show 17 study locations
Sponsors and Collaborators
Rapid Medical
Investigators
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Principal Investigator: Jeffrey L Saver, Dr. Geffen School of Medicine at UCLA
Principal Investigator: Rishi Gupta, Dr. WellStar Medical Group
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Responsible Party: Rapid Medical
ClinicalTrials.gov Identifier: NCT03474549    
Other Study ID Numbers: CLN-TI-001
First Posted: March 22, 2018    Key Record Dates
Last Update Posted: July 21, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by Rapid Medical:
Mechanical thrombectomy,
Brain
Brain clot
Brain infarction
Cerebral ischemia
Neurovascular intervention
Revascularization
Reperfusion
Stent retriever
Tigertriever
Stroke
Rapid Medical
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases