Treatment With Intent to Generate Endovascular Reperfusion

Ischemic Stroke Clinical Trial

— TIGER  

Official title:

Treatment With Intent to Generate Endovascular Reperfusion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03474549
• Other study ID #: CLN-TI-001
• Status: Completed
• Phase: N/A
• Start date: May 9, 2018
• Est. completion date: June 30, 2020

Study information

• Verified date: July 2020
• Source: Rapid Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: June 30, 2020
• Est. primary completion date: April 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Ischemic Stroke
• Stroke

Intervention

Device:
• Tigertriever revascularization device
Mechanical Thrombectomy

Locations

Country	Name	City	State
Israel	Rambam	Haifa
United States	Maimonides Medical Center	Brooklyn	New York
United States	University of Buffalo	Buffalo	New York
United States	Riverside Methodist Hospital	Columbus	Ohio
United States	Tenet Health	Coral Springs	Florida
United States	VBMC Harlingen	Harlingen	Texas
United States	University of Iowa	Iowa City	Iowa
United States	Baptist Health Research Institute	Jacksonville	Florida
United States	UCLA medical center	Los Angeles	California
United States	WellStar Research Institute	Marietta	Georgia
United States	Baptist Health South Florida	Miami	Florida
United States	University of Miami	Miami	Florida
United States	UPMC	Pittsburgh	Pennsylvania
United States	Oregon Health & Science University	Portland	Oregon
United States	Los Robles	Thousand Oaks	California
United States	Mercy Health	Toledo	Ohio
United States	University of Massachusetts	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Rapid Medical

Countries where clinical trial is conducted

United States,  Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Successful reperfusion, defined as mTICI Score = 2b	Effectiveness (Successful reperfusion)	Day 0 (end of procedure)
Primary	All-cause mortality	Safety (All-cause mortality)	90 days post treatment
Primary	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.	24 hours post procedure
Secondary	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.	90 days post treatment