NCT04201964

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
2mo left

Started Dec 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress98%
Dec 2019Jun 2026

First Submitted

Initial submission to the registry

December 15, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

December 15, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 17, 2019

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Last Updated

August 21, 2025

Status Verified

August 1, 2025

Enrollment Period

6.5 years

First QC Date

December 15, 2019

Last Update Submit

August 20, 2025

Conditions

Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

  • Proportion of sufficient recanalization

    sufficient recanalization is defined as TICI 2b-3

    immediately after local TNK treatment

Secondary Outcomes (2)

  • Proportion of favorable outcome

    90 days

  • proportion of early neurological improvement

    48 hours

Other Outcomes (1)

  • incidence of symptomatic intracranial haemorrhage

    48 hours

Study Arms (1)

Intra-arterial administration of tenecteplase

EXPERIMENTAL

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

Interventions

Intra-arterial administration of tenecteplaseDRUG

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

Intra-arterial administration of tenecteplase

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General Hospital of Northern Theater Command

Shenyang, 110840, China

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Zi-Ai Zhao, Doctor

CONTACT

+86 17790998175zhaoziai@hotmail.com

Lin Tao, Master

CONTACT

+86 188024016981939908868@qq.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 15, 2019

First Posted

December 17, 2019

Study Start

December 15, 2019

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

August 21, 2025

Record last verified: 2025-08

Locations

CN(1)