Improving Neuroprotective Strategy for Ischemic Stroke With Poor Recanalization After Thrombectomy by Intra-arterial TNK (INSIST-TNK)

Improving Neuroprotective Strategy for Ischemic Stroke With Poor Recanalization After Thrombectomy by Intra-arterial TNK (INSIST-TNK): a Prospective, Single Arm, Pilot Study

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04201964

Enrollment

Registered

2019-12-17

Start date

2019-12-15

Completion date

2028-06-30

Last updated

2026-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic Stroke

Brief summary

In 2015, five randomized trials showed efficacy of endovascular thrombectomy over standard medical care in patients with acute ischemic stroke caused by occlusion of arteries of the proximal anterior circulation. However, sufficient recanalization (mTICI2b-3) can 't be acquired in all patients under thrombectomy. There is a lack of evidence that whether salvage intra-arterial thrombolysis is beneficial for patients with insufficient recanalization after endovascular thrombectomy. The EXTEND-IA TNK study indicated that tenecteplase before thrombectomy was associated with a higher incidence of reperfusion and better functional outcome than alteplase among patients with ischemic stroke treated within 4.5 hours after symptom onset. This study intends to explore the proportion of sufficient recanalization (2b/3) after intra-arterial tenecteplase administration in patients undergoing thrombectomy with insufficient recanalization (1/2a).

Interventions

DRUGIntra-arterial administration of tenecteplase

Intra-arterial administration of tenecteplase (0.2-0.4 mg/min) immediately after thrombectomy device pass for 30-40 minutes.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Age ≥18 years; 2. Patients who presented with acute ischemic stroke and a large vessel occlusion in the anterior circulation and met the criteria of mechanical thrombectomy; 3. insufficient perfusion (mTICI 1/2a) after endovascular treatment; 4. The availability of informed consent.

Exclusion criteria

1. Sufficient recanalization (TICI 2b-3); 2. More than 3 times of thrombectomy device passes 3. Hemorrhagic stroke: cerebral hemorrhage, subarachnoid hemorrhage 4. Coagulation disorders, systematic hemorrhagic tendency, thrombocytopenia ( \<100000/mm3) 5. Severe hepatic or renal dysfunction, increase in ALT or AST (more than 2 times of upper limit of normal value), increase in serum creatinine (more than 1.5 times of upper limit of normal value) or requiring dialysis 6. Severe uncontrolled hypertension (systolic blood pressure over 200mmHg or diastolic blood pressure over 110 mmHg) 7. Patients allergic to any ingredient of drugs in our study 8. Unsuitable for this clinical studies assessed by researcher

Design outcomes

Primary

Measure	Time frame	Description
Proportion of sufficient recanalization	immediately after local TNK treatment	sufficient recanalization is defined as TICI 2b-3

Secondary

Measure	Time frame	Description
Proportion of favorable outcome	90 days	favorable outcome is defined as mRS 0-2
proportion of early neurological improvement	48 hours	early neurological improvement is defined as more than 4 decrease in NIHSS

Countries

China

Contacts

CONTACTZi-Ai Zhao, Doctor

zhaoziai@hotmail.com+86 17790998175

CONTACTLin Tao, Master

1939908868@qq.com+86 18802401698

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 12, 2026