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Recent studies revealed the safety and effectiveness of EVT in patients with acute occlusion at basilar artery, showing that up to 46% of patients receiving EVT had favorable functional outcome at 3 months (ATTENTION and BAOCHE trials, ESOC). Although the rate of successful recanalization can be as high as 90% , a large number of these patients remains to be functionally independent while recovery. In addition, a number of recent studies indicated the functional outcome of patients with successful recanalization of TICI 2b was not as good as those with TICI 3 grade. Therefore, restoring reperfusion of distal vessels and territorial microcirculation may be pivotal to further improvement of neurological outcomes for AIS patients receiving EVT. Correspondingly, a very recent Spanish multicenter randomized trial showed the effect of further functional improvement of post-EVT intra-arterial alteplase for successful mechanical thrombectomy in anterior circulation More importantly, head-to-head comparison between TNK and tPA showed the former has a significantly higher chance of reperfusion, indicating that TNK may be a potentially better candidate for post-EVT bridging.
Based on the above findings, we hypothesize in the present study that, adjunct intra-arterial tenecteplase after successful thrombectomy could enhance the functional improvement in patients with acute basilar artery occlusion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intra-arterial TNK infusion (0.4mg/min) via support/access catheter, over 15 minutes | Experimental |
| |
| intra-arterial TNK infusion (0.25mg/min) via support/access catheter, over 15 minutes | Experimental |
| |
| intra-arterial placebo infusion via support/access catheter, over 15 minutes | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tenecteplase for Injection | Drug | intra-arterial TNK infusing after successful thrombectomy for patient with acute basilar artery occlusion via support/access catheter |
|
| Measure | Description | Time Frame |
|---|---|---|
| mRS 0-3 | The proportion of patients with a modified Rankin Scale 0 to 3 at 90 days | 90 days |
| symptomatic ICH | The proportion of symptomatic ICH within 24 hours after allocated intervention | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| mRS 0-1 | The proportion of patients with a mRS 0 to 1 at 90 days | 90 days |
| mRS 0-2 | The proportion of patients with a mRS 0 to 2 at 90 days |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D000077785 | Tenecteplase |
| D007267 | Injections |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D010959 | Tissue Plasminogen Activator |
| D012697 | Serine Endopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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| Saline | Drug | intra-arterial saline infusing after successful thrombectomy for patient with acute basilar artery occlusion via support/access catheter |
|
| 90 days |
| mRS shift | The proportion of patients with a mRS shift at 90 days | 90 days |
| early neurological improvement | The proportion of patients with early neurological improvement (NIHSS reduction > 4) at 48 hours | 48 hours |
| PH1 and PH2 sICH | The proportion of subtypes (PH1 and PH2) of sICH within 24 hours after allocated intervention | 24 hours |
| mortality | The proportion of mortality at 90 days | 90 days |
| D006867 |
| Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D057057 | Serine Proteases |
| D010960 | Plasminogen Activators |
| D001779 | Blood Coagulation Factors |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |