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RecruitingNCT04201964Updated Sep 11, 2026

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

An interventional study of Intra-arterial administration of tenecteplase in Ischemic Stroke, sponsored by Hui-Sheng Chen. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-11.

Sponsored by Hui-Sheng Chen · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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).

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Conditions studied

  • Ischemic Stroke

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03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Intra-arterial administration of tenecteplase

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

    Drug: Intra-arterial administration of tenecteplase

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.

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What researchers measure

Primary outcomes

  1. Proportion of sufficient recanalization

    sufficient recanalization is defined as TICI 2b-3

    Time frame: immediately after local TNK treatment

Secondary outcomes

  1. Proportion of favorable outcome

    favorable outcome is defined as mRS 0-2

    Time frame: 90 days

  2. proportion of early neurological improvement

    early neurological improvement is defined as more than 4 decrease in NIHSS

    Time frame: 48 hours

Other outcomes

  1. incidence of symptomatic intracranial haemorrhage

    intracranial haemorrhage is defined as more than 4 increase in NIHSS caused by intracranial bleeding

    Time frame: 48 hours

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Study locations

1 of 1 sites recruiting
  • General Hospital of Northern Theater Command
    Shenyang, 110840, China
    • Zi-Ai Zhao · Contact
    Recruiting
07

Registry details

Key details

Study ID
NCT04201964
Lead sponsor
Hui-Sheng Chen
Responsible party
Hui-Sheng Chen (Professor, General Hospital of Shenyang Military Region) — Sponsor-investigator
First posted
Dec 17, 2019
Start date
Dec 15, 2019
Primary completion
Jun 30, 2028 (estimated)
Completion
Jun 30, 2028 (estimated)
Last update
Sep 11, 2026

Study contacts

Zi-Ai Zhao, Doctor
Contact
zhaoziai@hotmail.com
+86 17790998175
Lin Tao, Master
Contact
1939908868@qq.com
+86 18802401698

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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