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

Primary Purpose

Ischemic Stroke

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
intra-arterial tenecteplase administration
Sponsored by
General Hospital of Shenyang Military Region
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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. The subtype of ischemic stroke is large-artery atherosclerosis according to TOAST classification;
  4. The availability of informed consent.

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.

Sites / Locations

  • General Hospital of Northern Theater Command

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

intra-arterial tenecteplase administration

Arm Description

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

Outcomes

Primary Outcome Measures

Proportion of sufficient recanalization
sufficient recanalization is defined as TICI 2b-3

Secondary Outcome Measures

Proportion of favorable outcome
favorable outcome is defined as mRS 0-2
proportion of early neurological improvement
early neurological improvement is defined as more than 4 decrease in NIHSS

Full Information

First Posted
December 15, 2019
Last Updated
November 21, 2021
Sponsor
General Hospital of Shenyang Military Region
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1. Study Identification

Unique Protocol Identification Number
NCT04202458
Brief Title
Boosting REcanalization of Thrombectomy for Ischemic Stroke by Intra-arterial TNK (BRETIS-TNK)
Official Title
Boosting REcanalization of Thrombectomy for Ischemic Stroke by Intra-arterial TNK (BRETIS-TNK): a Prospective, Random, Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
December 15, 2019 (Actual)
Primary Completion Date
August 20, 2021 (Actual)
Study Completion Date
November 22, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
General Hospital of Shenyang Military Region

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
intra-arterial tenecteplase administration
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
intra-arterial tenecteplase administration
Intervention Description
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 Outcome Measure Information:
Title
Proportion of sufficient recanalization
Description
sufficient recanalization is defined as TICI 2b-3
Time Frame
Immediately after TNK treatment
Secondary Outcome Measure Information:
Title
Proportion of favorable outcome
Description
favorable outcome is defined as mRS 0-2
Time Frame
90 days
Title
proportion of early neurological improvement
Description
early neurological improvement is defined as more than 4 decrease in NIHSS
Time Frame
48 hours
Other Pre-specified Outcome Measures:
Title
incidence of symptomatic intracranial haemorrhage
Description
more than 4 increase in NIHSS caused by intracranial bleeding
Time Frame
48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
General Hospital of Northern Theater Command
City
ShenYang
ZIP/Postal Code
110840
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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