Reperfusion Completion Via Local Arterial Infusion of Tenecteplase After Incomplete Mechanical Thrombectomy
ConditionStroke
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorChuansheng Zhao
About this trial
To evaluate the efficacy and safety of intra-arterial TNK bridging therapy following incomplete recanalization (2b ≤ eTICI \< 3) after mechanical thrombectomy for acute anterior circulation large vessel occlusion.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years;
Time from symptom onset or last known well to randomization within 24 hours;
Clinical diagnosis of acute ischemic stroke caused by acute occlusion of the intracranial anterior circulation large vessels confirmed by CTA/MRA/DSA, including occlusion of the intracranial segment of the internal carotid artery, the M1 or M2 segments of the middle cerebral artery, with or without concomitant occlusion of the ipsilateral extracranial segment of the internal carotid artery;
NIHSS score ≥ 6, and meeting the current guidelines for mechanical thrombectomy;
Disqualifiers
Contraindications to intravenous thrombolysis (excluding time-based criteria);
DSA post-thrombectomy indicating dissection of the occluded artery, or intra-procedural flat-panel CT suggesting local hemorrhage or significant contrast extravasation;
Baseline NIHSS score not obtained;
Severe allergy or absolute contraindication to iodinated contrast media;
Trial design
Design model
Parallel
Treatments tested in this trial
Tenecteplase (0.0938mg/kg)
DrugPost-mechanical thrombectomy bridging therapy with intra-arterial tenecteplase (0.0938 mg/kg) for incomplete recanalization (2b ≤ eTICI \< 3).
Placebo
DrugPost-mechanical thrombectomy bridging "therapy" with intra-arterial placebo (0.0938 mg/kg) for incomplete recanalization (2b ≤ eTICI \< 3).
Treatment groups
344 Participants
are divided into 2 treatment groupsGroup A: Placebo GroupPlacebo comparator 1 intervention
Group B: Tenecteplase GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Excellent neurological outcome rate (mRS 0-1) at 90 (±7) days
Excellent neurological outcome rate (mRS 0-1) at 90 (±7) days
Time frame
3 months after randomizationSecondary outcomes
1
Change in eTICI grade on cerebral angiography
Change in eTICI grade on cerebral angiography
Time frame
Immediately after intra-arterial thrombolysis2
Proportion of patients with mRS score 0-2 at 90 (±7) days
Proportion of patients with mRS score 0-2 at 90 (±7) days
Time frame
3 months after randomization3
Proportion of patients with mRS score 0-3 at 90 (±7) days
Proportion of patients with mRS score 0-3 at 90 (±7) days
Time frame
3 months after randomization4
mRS shift analysis at 90 (±7) days
mRS shift analysis at 90 (±7) days
Time frame
3 months after randomizationOther outcomes
1
Incidence of symptomatic intracranial hemorrhage within 48 hours (Heidelberg criteria)
Incidence of symptomatic intracranial hemorrhage within 48 hours (Heidelberg criteria)
Time frame
48 hours after randomization2
Proportion of patients with an increase from baseline of ≥4 points in NIHSS score at 72 (±12) hours
Proportion of patients with an increase from baseline of ≥4 points in NIHSS score at 72 (±12) hours
Time frame
72 hours after randomization3
Mortality rate at 90 (±7) days
Mortality rate at 90 (±7) days
Time frame
3 months after randomization4
Incidence of asymptomatic intracranial hemorrhage
Incidence of asymptomatic intracranial hemorrhage
Time frame
0 hour, 24 hours, 48 hours, 7 days or discharge, and 90days after randomizationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Chuansheng Zhao
Lead sponsor
First Hospital of China Medical University
Sponsor institution
Source ClinicalTrials.gov
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