Intra-arterial TNK Following Endovascular Thrombectomy in Patients With Large Vessel Occlusion of Posterior Circulation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

208 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-24

Study Completion Date

2023-11-24

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Rationale: Recently, one prospective multicenter RCT reported a potential beneficial effect of intra-arterial alteplase following successful endovascular thrombectomy (EVT) in patients with an acute intracranial large vessel occlusion. In 2018, another prospective multicenter RCT supported the superiority of tenecteplase over alteplase in ischemic stroke patients with large vessel occlusion.

Objective: To assess the effect of EVT in addition to intra-arterial tenecteplase compared to EVT alone, in patients with large vessel occlusion of posterior circulation, on functional and safety outcomes.

Study design: This is a parallel group, randomized clinical trial of EVT with IA-TNK versus EVT. The trial has observer blind assessment of the primary outcome and of neuro-imaging at baseline and follow-up.

Study population: Patients with acute intracranial large vessel occlusion of posterior circulation and an eTICI 2b-3 after EVT.

Main study parameters/outcomes: The primary effect parameter will be excellent functional status at day 90 defined as a modified Rankin Score (mRS) of 0-1. The estimate will be adjusted for the known prognostic variables age, pre-stroke mRS, time from onset to randomization, stroke severity (NIHSS) and collaterals and adjusted and unadjusted estimates with corresponding 95% confidence intervals will be reported.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Endovascular Treatment With or Without Preceding Intravenous Tenecteplase (TNK) in Patients With Late-window acUte Ischemic Stroke Due to Middle Cerebral Artery Occlusion

NCT06221371

Ischemic Stroke, Acute Thrombolysis Endovascular Treatment

COMPLETED PHASE3

Neuronavigation-assisted Stereotactic Puncture With Tenecteplase for Acute Intracerebral Hemorrhage

NCT06868511

Deep Intracerebral Hemorrhage (ICH)

RECRUITING PHASE3

Endovascular Thrombectomy Alone Versus Intravenous Thrombolysis Plus Thrombectomy on Acute Basilar Artery Occlusion

NCT05827042

Basilar Artery Occlusion Acute Cerebrovascular Accident Stroke Due to Basilar Artery Occlusion

RECRUITING PHASE3

Direct Intra-arterial Thrombectomy in Order to Revascularize AIS Patients With Large Vessel Occlusion Efficiently in Chinese Tertiary Hospitals

NCT03469206

Ischemic Stroke Large Vessel Occlusion Thrombectomy +2 more

COMPLETED NA

Early Recanalization After Intravenous Thrombolysis With Tenecteplase Versus Alteplase in Distal Vessel Occlusion Strokes

NCT05635786

Acute Distal Vessel Occlusion Stroke

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Ischemic Stroke Intracranial Artery Occlusion Endovascular Thrombectomy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

endovascular thrombectomy

For patients randomized to the control group, EVT has to be completed within 24 hours of stroke onset. The choice of EVT strategy will be made by the treating neurointerventionalist. All mechanical thrombectomy devices for EVT, which are approved by CFDA for this purpose, are allowed in the trial.

Group Type ACTIVE_COMPARATOR

endovascular thrombectomy alone

Intervention Type OTHER

Patients will receive randomization if the eTICI score on cerebral angiography is 2b-3 and will stop the procedure if they have been assigned to the control group.

endovascular thrombectomy+intra-arterial tenecteplase

For patients randomized to the endovascular treatment arm, tenecteplase will be injected according to protocol, proceeding to inject TNK through a distal access catheter or microcatheter located proximal to the residual thrombus (if still present) and distally to the origin of the lenticulostriates branches. The administration of TNK will be infused for 15 seconds.

Group Type EXPERIMENTAL

Tenecteplase

Intervention Type DRUG

If patients are randomized and assigned to receive intra-arterial tenecteplase thrombolysis, tenecteplase will be injected according to protocol, proceeding to inject TNK through a distal access catheter or microcatheter located proximal to the residual thrombus (if still present) and distally to the origin of the pontine arteries.

endovascular thrombectomy alone

Intervention Type OTHER

Patients will receive randomization if the eTICI score on cerebral angiography is 2b-3 and will stop the procedure if they have been assigned to the control group.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Tenecteplase

If patients are randomized and assigned to receive intra-arterial tenecteplase thrombolysis, tenecteplase will be injected according to protocol, proceeding to inject TNK through a distal access catheter or microcatheter located proximal to the residual thrombus (if still present) and distally to the origin of the pontine arteries.

Intervention Type DRUG

endovascular thrombectomy alone

Patients will receive randomization if the eTICI score on cerebral angiography is 2b-3 and will stop the procedure if they have been assigned to the control group.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Acute ischemic stroke patients with symptomatic intracranial large vessel occlusion (LVO) in the intracranial vertebral artery, basilar artery, or the P1 segment of the posterior cerebral artery.
* Treated with endovascular thrombectomy (EVT) resulting in an eTICI score 2b50/3 at end of the procedure.
* Age of 18 years or older;
* National Institutes of Health Stroke Scale (NIHSS) score on admission≥6;
* Posterior Circulation ASPECTS ≥ 6 on CT/CTA-Source Images/MRI-DWI.
* Time from estimated time of basilar artery occlusion to randomization\<24 hours;
* Written informed consent.

Exclusion Criteria

* Pre-existing dependency with mRS \>1;
* Contraindication to Intravenous Thrombolysis (except time to therapy);
* Complete clinical recovery in the angiography suite by end of EVT procedure;
* Pregnancy; if a woman is of childbearing potential a urine or serum beta HCG test is positive;
* Severe contrast allergy or absolute contraindication to iodinated contrast;
* Participation in other investigational drug or device clinical trials;
* Systolic pressure \>185 mmHg or diastolic pressure \>110 mmHg, and cannot be controlled by antihypertensive drugs;
* Known genetic or acquired bleeding diathesis, lack of anticoagulant factors, or oral anticoagulant drugs and INR \> 1.7, or treated with direct oral anticoagulant agents in the prior 48 hours;
* platelets \<100 000/mm3, aPTT \>40 s, or PT \>15 s; Blood glucose \< 2.7 or \>22.2 mmol/L;
* Severe renal Failure as defined by a serum creatinine \> 3.0 mg/dl (or 265.2 μmol/l) or glomerular Filtration Rate \[GFR\] \< 30, or patient requires hemodialysis or peritoneal dialysis;
* Clinical presentation suggests a subarachnoid hemorrhage, even if initial CT or MRI scan is normal;
* Suspicion of aortic dissection;
* Presumed vasculitis or septic embolization;
* Life expectancy \< 1 year;
* Patients that cannot complete 90-day follow-up (e.g. no fixed residence, overseas patients, etc.)；
* CT/MR shows intracranial hemorrhage;
* Ischemic stroke within 3 months;
* Severe head trauma within 3 months;
* Major surgery or severe trauma within the last 2 weeks.
* History of prior intracranial hemorrhage.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No