Study on the Efficacy and Safety of T-02 for the Treatment for Acute Ischemic Stroke

NCT05342038 | Withdrawn

• 1 other identifier: BSI-FXE2-CLIP-001-01
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

To examine the revascularization efficacy and safety of T-02 and its associated performance characteristics in treatment of appropriately selected subjects experiencing an acute ischemic stroke when the treatment is initiated within 24 hours after last seen well under the current guideline, and to generate hypotheses to be confirmed in subsequent confirmatory clinical investigations

Conditions

Acute Ischemic Stroke; Large Vessel Occlusion; Vascular Occlusion; Thrombosis; Endovascular

Keywords

Thrombectomy; stent retriever; revascularization; restoring flow; reperfusion; clot; thrombus

Outcome Measures

Primary Outcomes (2)

• eTICI 2b-3

  Successful revascularization measured using eTICI score ≥2b in the target vessel following 3 or less passes of T-02 device(s).

  immediately after the intervention

• sICH

  Incidence of symptomatic intracranial hemorrhage (SICH), by ECASS III definition, within 24 (-8/+12) hours post procedure

  within 24 hours

Secondary Outcomes (5)

• modified Rankin scale (mRS)

  90 days

• mRS 0-2 rate

  90 days

• NIHSS score

  Day 5-12 / Discharge (whichever is earlier)

• Stroke-rerated mortality

  90 days

• All-cause mortality

  90 days

Study Arms (1)

Single Arm

EXPERIMENTAL

T-02

Device: T-02

Interventions

T-02 DEVICE

Stent retriever

Also known as: Tron FX

Single Arm

Eligibility Criteria

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

You may qualify if:

• Clinical signs and symptoms consistent with the diagnosis of an acute ischemic stroke
• Subject can be treated within 24 hours after time last seen well (TLSW)
• Subject belongs to one of the following subgroups:
• Subject has received IV t-PA therapy; or
• Subject is contraindicated for IV t-PA administration
• Baseline NIHSS ≥6
• No significant pre-stroke disability (pre-stroke mRS must be 0 or 1)
• Age ≥18
• Baseline ASPECTS ≥6
• Subject willing/able to return for protocol required follow up visits
• Subject or subject's Legally Authorized Representative (LAR) has signed the study Informed Consent form,
• If the procedure will start within 6 hours after the time last seen well, the occlusion site is identified as the intracranial ICA, MCA (M1, M2, M3), ACA (A1, A2), PCA (P1, P2), BA or VA as evidenced by MRA or CTA
• If the procedure will start between 6 and 12 hours after the time last seen well, one of the following (i) to (iii) is defined:
• (i) ESCAPE criteria (if CTP-rCBF is not available or cannot be analyzed )
• \- the occlusion site is identified as the intracranial ICA, MCA (M1, M2, M3), ACA (A1, A2), PCA (P1, P2), BA or VA as evidenced by MRA or CTA; and

You may not qualify if:

• \- 1. Patients having allergy or contraindication to contrast agents or significant allergy to metals 2. Patients who have been administered heparin within 48 hours and PTT/ APTT exceeded double the normal values\* 3. Patients with known hemorrhagic diathesis, OR blood clotting factor deficiency OR patient who underwent oral anticoagulant therapy (warfarin etc.), patient whose INR exceeds 3\* 4. Patients with the platelet count under 30,000 mm3 5. Patients with a blood sugar level under 50 mg/dL 6. Patients with hypertension (systolic \>185 mmHg, diastolic \>110 mmHg) which cannot be controlled by drugs 7. Patients whose estimated life expectancy is less than 6 months 8. Pregnant OR lactating female patients 9. Patients participating in trials of medical products OR medical devices 10. Patients who were judged as inappropriate to participate in this trial due to reasons other than those mentioned above by the principal investigator (sub-investigator) for the study 11. Pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations, e.g. dementia with prescribed anti-cholinesterase inhibitor (e.g. Aricept) 12. Seizures at stroke onset if it makes the diagnosis of stroke doubtful and precludes obtaining an accurate baseline NIHSS assessment 13. Baseline hemoglobin counts of \<7 mmol/L (11.28 g/dL) 14. Abnormal baseline electrolyte parameters as defined by sodium concentration \<130 mmol/L, potassium concentration \<3 mEq/L or \>6 mEq/L 15. Renal failure as defined by a serum creatinine \>3.0 mg/dL (264 µmol/L) 16. Any active or recent hemorrhage within the past 30 days 17. Presumed septic embolus, or suspicion of bacterial endocarditis 18. Treatment with any cleared thrombectomy devices or other intra-arterial (neurovascular) therapies prior to the procedure 19. Evidence of intracranial hemorrhage on pre-treatment CT/MRI 20. CTA or MRA evidence of flow limiting carotid dissection, high-grade stenosis, or complete cervical carotid occlusion requiring stenting at the time of the index procedure (i.e., mechanical thrombectomy).
• \. Excessive tortuosity of cervical vessels on CTA/MRA that would likely preclude device delivery/deployment 22. Suspected cerebral vasculitis based on medical history and CTA/MRA 23. Suspected aortic dissection based on medical history and CTA/MRA 24. Intracranial stent implanted in the same vascular territory that would preclude the safe deployment/removal of the investigational device 25. Acute symptomatic arterial occlusions in more than one vascular territory confirmed on CTA/MRA (e.g., bilateral MCA occlusions, or an MCA and basilar artery occlusion).

Sponsors & Collaborators

• Biomedical Solutions Inc.: lead

MeSH Terms

Conditions

Ischemic Stroke; Thrombosis

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Embolism and Thrombosis

Study Officials

• Igor J. Kocijančič, MD

  University Medical Centre Ljubljana

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 15, 2022
• First Posted: April 22, 2022
• Study Start: April 22, 2022
• Primary Completion: January 31, 2023
• Study Completion: April 30, 2023
• Last Updated: June 7, 2023

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share