Tigertriever Distal Vessels Registry

NCT03871309 | Terminated

• 1 other identifier: 005-035-006-ANTR-0607
• Study Type: observational
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ischemic Stroke

Outcome Measures

Primary Outcomes (4)

• 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)

Study Arms (1)

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

Interventions

Tigertriever DEVICE

Mechanical Thrombectomy

Tigertriever

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Rapid Medical: lead

Study Sites (1)

Imperial College Healthcare

London, United Kingdom

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Kyri Lobotesis, MD

  Imperial College Healthcare

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2019
• First Posted: March 12, 2019
• Study Start: February 7, 2020
• Primary Completion: August 4, 2022
• Study Completion: October 10, 2023
• Last Updated: April 12, 2024

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)