Treatment With Intent to Generate Endovascular Reperfusion

NCT03474549 | Completed Results DMC FDA Device

• 1 other identifier: CLN-TI-001
• Study Type: interventional
• Target: 160
• Locations: 2 countries
• Sites: 17

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.

Conditions

Ischemic Stroke

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Successful Reperfusion, Defined as mTICI Score ≥ 2b

  Effectiveness (Successful reperfusion)

  Day 0 (end of procedure)

• All-cause Mortality

  Safety (All-cause mortality)

  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.

  24 hours post procedure

Secondary Outcomes (1)

• Modified Rankin Scale (mRS) Score of ≤2

  90 days post treatment

Study Arms (1)

Tigertriever revascularization device

EXPERIMENTAL

Mechanical thrombectomy with Tigertriever

Device: Tigertriever revascularization device

Interventions

Tigertriever revascularization device DEVICE

Mechanical Thrombectomy

Tigertriever revascularization device

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Rapid Medical: lead

Study Sites (17)

UCLA medical center

Los Angeles, California, 90095, United States

Location

Los Robles

Thousand Oaks, California, 91360, United States

Location

Tenet Health

Coral Springs, Florida, 33076, United States

Location

Baptist Health Research Institute

Jacksonville, Florida, 32207, United States

Location

Baptist Health South Florida

Miami, Florida, 33176, United States

Location

University of Miami

Miami, Florida, 33316, United States

Location

WellStar Research Institute

Marietta, Georgia, 30060, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

University of Massachusetts

Worcester, Massachusetts, 01655, United States

Location

Maimonides Medical Center

Brooklyn, New York, 11219, United States

Location

University of Buffalo

Buffalo, New York, 14203, United States

Location

Riverside Methodist Hospital

Columbus, Ohio, 43214, United States

Location

Mercy Health

Toledo, Ohio, 43604, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

VBMC Harlingen

Harlingen, Texas, 78550, United States

Location

Rambam

Haifa, Israel

Location

Related Publications (1)

• 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.

  PMID: 33739136 DERIVED

MeSH Terms

Conditions

Ischemic Stroke; Brain Infarction; Brain Ischemia; Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Results Point of Contact

• Title: Dr. Walid Haddad- Chief Clinical Officer
• Organization: Rapid-Medical

walid@rapid-medical.com

+972 72 2503331

Study Officials

• Jeffrey L Saver, Dr.

  Geffen School of Medicine at UCLA

  PRINCIPAL INVESTIGATOR

• Rishi Gupta, Dr.

  WellStar Medical Group

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2018
• First Posted: March 22, 2018
• Study Start: May 9, 2018
• Primary Completion: April 15, 2020
• Study Completion: June 30, 2020
• Last Updated: May 8, 2024
• Results First Posted: May 8, 2024

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1); US (16)