Back to results

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

Primary Purpose

Ischemic Stroke

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Intra-arterial administration of tenecteplase

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:

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

Sites / Locations

General Hospital of Northern Theater CommandRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intra-arterial administration of tenecteplase

Arm Description

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

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

NCT ID

NCT04201964

First Posted

December 15, 2019

Last Updated

May 23, 2023

Sponsor

Hui-Sheng Chen

1. Study Identification

Unique Protocol Identification Number

NCT04201964

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

December 15, 2019 (Actual)

Primary Completion Date

December 30, 2023 (Anticipated)

Study Completion Date

December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Hui-Sheng Chen

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief 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).

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 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intra-arterial administration of tenecteplase

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Intra-arterial administration of tenecteplase

Intervention Description

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

Primary Outcome Measure Information:

Title

Proportion of sufficient recanalization

Description

sufficient recanalization is defined as TICI 2b-3

Time Frame

immediately after local 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

intracranial haemorrhage is defined as 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

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; 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Zi-Ai Zhao, Doctor

Phone

+86 17790998175

zhaoziai@hotmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Lin Tao, Master

Phone

+86 18802401698

1939908868@qq.com

Facility Information:

Facility Name

General Hospital of Northern Theater Command

City

ShenYang

ZIP/Postal Code

110840

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Zi-Ai Zhao

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs