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CompletedNCT04202458Updated Nov 23, 2021

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

An interventional study of intra-arterial tenecteplase administration in Ischemic Stroke, sponsored by General Hospital of Shenyang Military Region. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-11-23.

Sponsored by General Hospital of Shenyang Military Region · Not applicable, Interventional, and Treatment

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

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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Conditions studied

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In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's enrollment of 30 is below the median of 50 across 5,369 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

General Hospital of Shenyang Military Region is the lead sponsor of 78 studies on the registry; 33 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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

Exclusion criteria

Exclusion Criteria:

  1. Other sub-types of ischemic stroke such as cardioembolism.
  2. Hemorrhagic stroke such as cerebral hemorrhage, subarachnoid hemorrhage.
  3. Coagulation disorders, systematic hemorrhagic tendency, thrombocytopenia (\<100000/mm3).
  4. 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.
  5. Severe uncontrolled hypertension (systolic blood pressure over 200mmHg or diastolic blood pressure over 110 mmHg).
  6. Patients allergic to any ingredient of drugs in our study.
  7. 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 (actual)

Study arms

  • Experimental
    intra-arterial tenecteplase administration

    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

    Drug: intra-arterial tenecteplase administration

Interventions

  • Drugintra-arterial tenecteplase administration

    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.

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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 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

    more than 4 increase in NIHSS caused by intracranial bleeding

    Time frame: 48 hours

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Study locations

1 site
  • General Hospital of Northern Theater Command
    ShenYang, 110840, China
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 23, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04202458
Lead sponsor
General Hospital of Shenyang Military Region
Responsible party
Hui-Sheng Chen (Professor, General Hospital of Shenyang Military Region) — Principal investigator
First posted
Dec 17, 2019
Start date
Dec 15, 2019
Primary completion
Aug 20, 2021
Completion
Nov 22, 2021
Last update
Nov 23, 2021

Oversight

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

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This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.

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