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NCT Number: NCT04202458

Boosting REcanalization of Thrombectomy for Ischemic Stroke by Intra-arterial TNK (BRETIS-TNK)

Thrombolysis and endovascular thrombectomy are the most efficient treatments for acute ischemic stroke patients in time window. However, sufficient recanalization (mTICI2b-3) can 't be acquired in all patients under 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 whether a combination of thrombectomy and intra-arterial TNK administration can increase recanalization rate after the first attempt of thrombectomy device pass for ischemic Stroke.

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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

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;
  • The subtype of ischemic stroke is large-artery atherosclerosis according to TOAST classification;
  • The availability of informed consent.

Exclusion criteria

  • Other sub-types of ischemic stroke such as cardioembolism.
  • Hemorrhagic stroke such as 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 tenecteplase administration

Drug

Intra-arterial administration of 4mg tenecteplase is given after microcatheter navigation through the clot. Intra-arterial administration of tenecteplase (0.4 mg/min) continuously is given after the first attempt of thrombectomy device pass for 30 minutes, and then followed by DSA.

Primary outcomes

  1. Proportion of sufficient recanalization

    Time frame: Immediately after 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

    more than 4 increase in NIHSS caused by intracranial bleeding

Sponsors and collaborators

Lead sponsor

General Hospital of Shenyang Military Region

Other

Registry information

Official study title

Boosting REcanalization of Thrombectomy for Ischemic Stroke by Intra-arterial TNK (BRETIS-TNK): a Prospective, Random, Pilot Study

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Dec 17, 2019
Registry last updated
Nov 23, 2021

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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