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NCT Number: NCT04201964

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

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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Key information

Conditions

Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

General Hospital of Northern Theater Command

Shenyang, 110840, China

Location status: Recruiting

Location contact

Zi-Ai Zhao

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Sufficient recanalization (TICI 2b-3);
  • More than 3 times of thrombectomy device passes
  • Hemorrhagic stroke: cerebral hemorrhage, subarachnoid hemorrhage
  • Coagulation disorders, systematic hemorrhagic tendency, thrombocytopenia ( <100000/mm3)
  • 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
  • Severe uncontrolled hypertension (systolic blood pressure over 200mmHg or diastolic blood pressure over 110 mmHg)
  • Patients allergic to any ingredient of drugs in our study
  • Unsuitable for this clinical studies assessed by researcher

Treatment and study plan

Intra-arterial administration of tenecteplase

Drug

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

Primary outcomes

  1. Proportion of sufficient recanalization

    Time frame: immediately after local TNK treatment

    sufficient recanalization is defined as TICI 2b-3

Secondary outcomes

  1. Proportion of favorable outcome

    Time frame: 90 days

    favorable outcome is defined as mRS 0-2

  2. proportion of early neurological improvement

    Time frame: 48 hours

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

Other outcomes

  1. incidence of symptomatic intracranial haemorrhage

    Time frame: 48 hours

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

Study contacts

Contact information is provided by the study sponsor or research team.

Lin Tao, Master

CONTACT

[email protected]

+86 18802401698

Zi-Ai Zhao, Doctor

CONTACT

[email protected]

+86 17790998175

Sponsors and collaborators

Lead sponsor

Hui-Sheng Chen

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Dec 17, 2019
Registry last updated
Aug 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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