Tigertriever Distal Vessels Registry

A registry study to collect data on the Tigertriever device at restoring blood flow by removing clots in M2 or distal vessels in patients experiencing acute ischemic stroke, during commercial use.

Study Overview

• Status: Terminated
• Conditions: Ischemic Stroke
• Intervention / Treatment: Device: Tigertriever

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 9

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom
    • Imperial College Healthcare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Male or female patients (age ≥18) who present with an acute ischemic stroke due to a M2 or distal (medium to small) vessel occlusion confirmed by vessel imaging and treated with the Tigertriever 17 or 13 revascularization devices.

Description

Inclusion Criteria:

• Patients who present with acute ischemic stroke, who can be treated within 6 hours of symptoms onset, who are either refractory to or ineligible for IV t-PA treatment and intend to be treated with thrombectomy.
• Patients ≥18
• NIHSS Score of ≥2
• Angiographically confirmed occlusion in a M2 or distal (medium to small) branch that is accessible to the Tigertriever device (17 or 13) as determined by the vessel diameter (≥1mm).
• Anticipated life expectancy of at least 6 months from presentation
• Signed informed consent form by the patient or a legally acceptable representative.

Exclusion Criteria:

• Extended infarct - ischemic changes >1/3 MCA territory / 100 ml tissue or ASPECT score <5

  • Pre- stroke mRS ≥ 2
  • Unknown time of stroke symptom onset
  • Vessel diameter < 1mm
  • Angiographically evident extreme vessel tortuosity that may preclude the device from reaching the target area.
  • Occlusion/stenosis proximal to thrombus that precludes safe retrieval
  • Medical co-morbidities including but not limited to:
  • Uncontrolled coagulopathy such as International Normalized Ratio (INR) of > 3.0 or platelets count < 40 x109/L or APTT >50 sec
  • Serious concurrent medical illness: myocardial infarction, seizures, sepsis, uncontrolled diabetes, uncontrolled hypertension, brain tumor, renal impairment (eGFR <60).
  • Baseline glucose < 2.7 or > 22.2 mmol/L

  • Imaging features of:

    • raised intracranial pressure or significant mass effect (for example, midline shift, severe sulcal effacement, transcompartmental herniation)
    • intracranial hemorrhage
    • vascular malformation or aneurysm
    • significant vascular abnormality such as carotid dissection, complete carotid occlusion or large/medium vessel vasculitis
  • Allergy/sensitivity to nickel-titanium or contrast media
  • Females who are pregnant or lactating
  • Unable to obtain informed consent from the patient or a suitable legal representative
  • Any other contraindication to thrombectomy

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Tigertriever; Male or female patients (age ≥18) who present with an acute ischemic stroke due to a M2 or distal (medium to small) vessel occlusion confirmed by vessel imaging and treated with the Tigertriever 17 or 13 revascularization devices.	Device: Tigertriever; Mechanical Thrombectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of participants with Symptomatic Intracranial Hemorrhage (SICH) or new infarct within 24 (±12) hours post-procedure.	Safety Endpoints. SICH shall be defined as Parenchymal Hematoma type 2 coupled with ≥4-point NIHSS deterioration at 24 hours.	24 hours post procedure
Percentage of participants with a new occlusion.	Safety Endpoints.	Day 0 (end of procedure)
Percentage of participants with a TICI Score ≥IIb post procedure.	Effectiveness Endpoints	Day 0 (end of procedure)
Percentage of participants with a TICI Score ≥IIb post procedure after first pass.	Effectiveness Endpoints	Day 0 (end of procedure)

Collaborators and Investigators

• Sponsor: Rapid Medical
• Investigators: Principal Investigator: Kyri Lobotesis, MD, Imperial College Healthcare

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2020
• Primary Completion (Actual): August 4, 2022
• Study Completion (Actual): October 10, 2023

Study Registration Dates

• First Submitted: February 21, 2019
• First Submitted That Met QC Criteria: March 8, 2019
• First Posted (Actual): March 12, 2019

Study Record Updates

• Last Update Posted (Actual): April 12, 2024
• Last Update Submitted That Met QC Criteria: April 10, 2024
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: 005-035-006-ANTR-0607

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No