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

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

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).

Study Overview

• Status: Recruiting
• Conditions: Ischemic Stroke
• Intervention / Treatment: Drug: Intra-arterial administration of tenecteplase

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zi-Ai Zhao, Doctor; Phone Number: +86 17790998175; Email: zhaoziai@hotmail.com
• Study Contact Backup: Name: Lin Tao, Master; Phone Number: +86 18802401698; Email: 1939908868@qq.com

Study Locations

• China
  • ShenYang, China, 110840
    • Recruiting
    • General Hospital of Northern Theater Command
    • Contact: Zi-Ai Zhao

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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. insufficient perfusion (mTICI 1/2a) after endovascular treatment;
4. The availability of informed consent.

Exclusion Criteria:

1. Sufficient recanalization (TICI 2b-3);
2. More than 3 times of thrombectomy device passes
3. Hemorrhagic stroke: cerebral hemorrhage, subarachnoid hemorrhage
4. Coagulation disorders, systematic hemorrhagic tendency, thrombocytopenia ( <100000/mm3)
5. 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
6. Severe uncontrolled hypertension (systolic blood pressure over 200mmHg or diastolic blood pressure over 110 mmHg)
7. Patients allergic to any ingredient of drugs in our study
8. Unsuitable for this clinical studies assessed by researcher

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intra-arterial administration of tenecteplase; Intra-arterial administration of tenecteplase (0.2-0.4 mg/min) immediately after thrombectomy device pass for 30-40 minutes.	Drug: Intra-arterial administration of tenecteplase; Intra-arterial administration of tenecteplase (0.2-0.4 mg/min) immediately after thrombectomy device pass for 30-40 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of sufficient recanalization	sufficient recanalization is defined as TICI 2b-3	immediately after local TNK treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of favorable outcome	favorable outcome is defined as mRS 0-2	90 days
proportion of early neurological improvement	early neurological improvement is defined as more than 4 decrease in NIHSS	48 hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of symptomatic intracranial haemorrhage	intracranial haemorrhage is defined as more than 4 increase in NIHSS caused by intracranial bleeding	48 hours

Collaborators and Investigators

• Sponsor: Hui-Sheng Chen

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2019
• Primary Completion (Estimated): December 30, 2023
• Study Completion (Estimated): December 30, 2023

Study Registration Dates

• First Submitted: December 15, 2019
• First Submitted That Met QC Criteria: December 15, 2019
• First Posted (Actual): December 17, 2019

Study Record Updates

• Last Update Posted (Actual): May 25, 2023
• Last Update Submitted That Met QC Criteria: May 23, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Infarction; Brain Infarction; Stroke; Ischemic Stroke; Ischemia; Cerebral Infarction; Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Tenecteplase
• Other Study ID Numbers: k(2019)30

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No