Tigertriever Distal Vessels Registry

Ischemic Stroke Clinical Trial

Official title:

Tigertriever Distal Vessels Registry

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03871309
• Other study ID #: 005-035-006-ANTR-0607
• Status: Terminated
• Start date: February 7, 2020
• Est. completion date: October 10, 2023

Study information

• Verified date: October 2022
• Source: Rapid Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: October 10, 2023
• Est. primary completion date: August 4, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ischemic Stroke

Intervention

Device:
• Tigertriever
Mechanical Thrombectomy

Locations

Country	Name	City	State
United Kingdom	Imperial College Healthcare	London

Sponsors (1)

Lead Sponsor	Collaborator
Rapid Medical

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Percentage of participants with a new occlusion.	Safety Endpoints.	Day 0 (end of procedure)
Primary	Percentage of participants with a TICI Score =IIb post procedure.	Effectiveness Endpoints	Day 0 (end of procedure)
Primary	Percentage of participants with a TICI Score =IIb post procedure after first pass.	Effectiveness Endpoints	Day 0 (end of procedure)