Acute Ischemic StrokeT-02NCT05342038

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

A study testing T-02 in people with Acute Ischemic Stroke and Large Vessel Occlusion, run by Biomedical Solutions Inc..

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Acute Ischemic Stroke, Large Vessel Occlusion, Vascular Occlusion
What is being tested?: T-02
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: No sites listed yet
Study dates: 22 Apr 2022to 30 Apr 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Show all 31Show fewer

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:
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
Moderate-to-good collateral circulation in MRA or CTA, (ii) Clinical Imaging Mismatch (CIM):
the occlusion site is identified as ICA or MCA (M1) as evidenced by MRA or CTA, and defined as one of the following on MR-DWI or CTP-rCBF maps:
Age < 80; infarct core ≤30 ml if NIHSS ≥10;
Age < 80; infarct core 31 to 50 ml if NIHSS ≥20; or
Age ≥ 80; infarct core ≤20 ml if NIHSS ≥10, (iii) Target Mismatch (TM):
the occlusion site is identified as ICA or MCA (M1) as evidenced by MRA or CTA; Age ≤90; NIHSS ≥6; and
defined as following on MR-DWI or CTP-rCBF maps: infarct core volume <70 ml; Penumbra volume >15 ml; and Penumbra volume/core volume >1.8,
If the procedure will start between 12 and 16 hours after the time last seen well, the occlusion site is identified as ICA or MCA (M1) as evidenced by MRA or CTA, and (i) Clinical Imaging Mismatch (CIM) or (ii) Target Mismatch (TM) is defined as one of the following on MR-DWI or CTP-rCBF maps:
Clinical Imaging Mismatch (CIM):
Age < 80; infarct core ≤30 ml if NIHSS ≥10;
Age < 80; infarct core 31 to 50 ml if NIHSS ≥20; or
Age ≥ 80; infarct core ≤20 ml if NIHSS ≥10 (ii) Target Mismatch (TM): Age ≤90; NIHSS ≥6; Infarct core volume <70 ml; Penumbra volume >15 ml; and Penumbra volume/core volume >1.8
If the procedure will start between 16 and 24 hours after the time last seen well, the occlusion site is identified as ICA or MCA (M1) as evidenced by MRA or CTA, and (i) Clinical Imaging Mismatch (CIM) is defined as one of the following on MR-DWI or CTP-rCBF maps:
Age < 80; infarct core ≤30 ml if NIHSS ≥10;
Age < 80; infarct core 31 to 50 ml if NIHSS ≥20; or
Age ≥ 80; infarct core ≤20 ml if NIHSS ≥10

Who cannot join

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).
21. 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).

About this study

Official title: Single-center, Single-Arm Study on the Efficacy and Safety of T-02 for the Treatment for Acute Ischemic Stroke

Read the detailed description

Stroke is the second leading cause of death and the third leading cause of disability worldwide, with a 16 million incidence. The Global prevalence of stroke was 104.2 million people, whereas that of ischemic stroke was 82.4 million in 2017. Countries in Eastern Europe and Central and East Asia have the highest prevalence rates of ischemic stroke, and countries in Eastern Europe, North Africa and Central Asia have among the highest mortality rates attributable to ischemic stroke.

Each year, there are about 800 000 new or recurrent cases of stroke in the United State. With all the advancements, 13.6% is still die. The incidence of large vessel occlusion (LVO) compromise 24% to 38% of acute ischemic stroke. The proportion increases to 46% on including A2 and P2 segments. Two-thirds of LVO occur in the anterior circulation, mainly in the Internal Carotid Artery (ICA) and Middle Cerebral Artery (MCA), and the remaining occur in the posterior circulation.

Intravenous tissue plasminogen activator (IV-tPA) was found to have some benefits to treat an acute ischemic stroke (AIS). However, IV-tPA has many limitations, including a short therapeutic window with administration being restricted to 4.5 hours post known symptom onset, and a strong time dependency. Another limitation is the high pharmacological resistance for more proximal occlusion (4%-8% for ICA vs 31%-44% distal recanalization).

T-02 which is the study device is indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion (LVO) such as internal carotid artery (ICA) and middle cerebral artery (MCA) segments as well as Medium-vessel occlusions (MeVOs) including M2 and M3 with smaller core infarcts. Endovascular therapy with the device should start up to 24 hours of time last seen well in patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy.

This study will be conducted:

To confirm that T-02 has similar efficacy and safety for treating European patients presenting acute ischemic stroke including distal vessel region such as M3 within 6 hours after time last seen well (TLSW) according to European Guidelines in comparison with the ones of stent retrievers available on the market;
To generate hypotheses for subsequent confirmatory clinical investigations to evaluate the efficacy and safety of T-02 and its associated performance characteristics in treatment of appropriately selected patients presenting AIS within 24 hours after TLSW while following the eligible criteria recommended by the current European guideline.

Conditions: Acute Ischemic Stroke, Large Vessel Occlusion, Vascular Occlusion, Thrombosis, Endovascular
Being tested: T-02
Keywords: Thrombectomy, stent retriever, revascularization, restoring flow, reperfusion, clot, thrombus
Medical subject headings: Ischemic Stroke, Thrombosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

T-02Device
Also called Tron FX
Stent retriever

Study groups in NCT05342038
Study group	Role	What they receive
Single Arm	Experimental	T-02 Receives: Device: T-02

What is being measured

The primary outcome is the main question the study is designed to answer.

eTICI 2b-3
Successful revascularization measured using eTICI score ≥2b in the target vessel following 3 or less passes of T-02 device(s).
Measured: immediately after the intervention
sICH
Incidence of symptomatic intracranial hemorrhage (SICH), by ECASS III definition, within 24 (-8/+12) hours post procedure
Measured: within 24 hours

Secondary outcomes (5)

modified Rankin scale (mRS)
90-day disability assessed by the modified Rankin scale (mRS) defined between 1 to 6 wherein higher scores mean a worse outcome.
Measured: 90 days
mRS 0-2 rate
The proportion of subjects with a good functional outcome at 90 days defined as mRS 0-2 with and without adjunction treatment, respectively.
Measured: 90 days
NIHSS score
The proportion of subjects with "early response", defined as a NIHSS drop of ≥10 from baseline of or NIHSS score 0 or 1 ( NIHSS score is defined between 1 and 42 wherein higher scores mean a worst outcome.)
Measured: Day 5-12 / Discharge (whichever is earlier)
Stroke-rerated mortality
Incidence of stroke-rerated mortality at 90 days
Measured: 90 days
All-cause mortality
Incidence of all-cause mortality at 90 days
Measured: 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Apr 202230 Apr 2023

First posted22 Apr 2022
Study start22 Apr 2022
Primary completion31 Jan 2023 (estimated)
Study completion30 Apr 2023

Why it stopped: Change of business strategy of Sponsor

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05342038
Sponsor's protocol ID: BSI-FXE2-CLIP-001-01
Acronym: T-02
Status last verified: Apr 2022
First submitted: 15 Apr 2022
Last updated: 7 Jun 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Acute Ischemic Stroke trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Single-center, Single-Arm Study on the Efficacy and Safety of T-02 for the Treatment for Acute Ischemic Stroke
ClinicalTrials.gov ID: NCT05342038
Acronym / sponsor ID: T-02 / BSI-FXE2-CLIP-001-01
Conditions: Acute Ischemic Stroke, Large Vessel Occlusion, Vascular Occlusion, Thrombosis, Endovascular
Keywords: Thrombectomy, stent retriever, revascularization, restoring flow, reperfusion, clot, thrombus
Study type: Interventional
Recruitment status: WithdrawnReason stopped: Change of business strategy of Sponsor
Enrolment: 0 participants (actual)
Lead sponsor: Biomedical Solutions Inc.Industry (pharma, biotech, devices)
Study start: 22 Apr 2022 (actual)
Primary completion: 31 Jan 2023 (estimated)
Study completion: 30 Apr 2023 (actual)
First posted: 22 Apr 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

This study will be conducted:

To confirm that T-02 has similar efficacy and safety for treating European patients presenting acute ischemic stroke including distal vessel region such as M3 within 6 hours after time last seen well (TLSW) according to European Guidelines in comparison with the ones of stent retrievers available on the market;
To generate hypotheses for subsequent confirmatory clinical investigations to evaluate the efficacy and safety of T-02 and its associated performance characteristics in treatment of appropriately selected patients presenting AIS within 24 hours after TLSW while following the eligible criteria recommended by the current European guideline.

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Single Arm	Experimental	Device: T-02T-02

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (31 listed)

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:
Baseline NIHSS ≥6
No significant pre-stroke disability (pre-stroke mRS must be 0 or 1)

Key exclusion criteria (2 listed)

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).
21. 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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
T-02Also: Tron FXStent retriever	Device	Single Arm

Primary outcome

eTICI 2b-3
Time frame: immediately after the intervention
Successful revascularization measured using eTICI score ≥2b in the target vessel following 3 or less passes of T-02 device(s).
sICH
Time frame: within 24 hours
Incidence of symptomatic intracranial hemorrhage (SICH), by ECASS III definition, within 24 (-8/+12) hours post procedure

5 secondary outcomes

modified Rankin scale (mRS)
Time frame: 90 days
mRS 0-2 rate
Time frame: 90 days
NIHSS score
Time frame: Day 5-12 / Discharge (whichever is earlier)
Stroke-rerated mortality
Time frame: 90 days
All-cause mortality
Time frame: 90 days

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2023.
Individual participant dataSharing planned: No

Related trials for Acute Ischemic Stroke

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Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
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RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Igor J. Kocijančič, MD principal investigator

University Medical Centre Ljubljana

Questions about this trial

What is this clinical trial studying?

A study testing T-02 in people with Acute Ischemic Stroke and Large Vessel Occlusion, run by Biomedical Solutions Inc..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 31 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 7 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

eTICI 2b-3 (time frame: immediately after the intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05342038.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2023.