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

NCT ID: NCT04201964

Last Updated: 2025-08-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-15
• Study Completion Date: 2026-06-30

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).

Conditions

Ischemic Stroke

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Intra-arterial administration of tenecteplase

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hui-Sheng Chen

OTHER

Sponsor Role: lead

Responsible Party

Hui-Sheng Chen

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

General Hospital of Northern Theater Command

Shenyang, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Zi-Ai Zhao, Doctor

Role: CONTACT

zhaoziai@hotmail.com

+86 17790998175

Lin Tao, Master

Role: CONTACT

1939908868@qq.com

+86 18802401698

Facility Contacts

Zi-Ai Zhao

Role: primary

Other Identifiers

k(2019)30

Identifier Type: -

Identifier Source: org_study_id