Rescue Thrombolysis for Medium Vessel Occlusion (RESCUE-TNK) | NCT05657470

Studies
Rescue Thrombolysis for Medium Vessel Occlusion (RESCUE-TNK)

NCT05657470

Sponsor

General Hospital of Shenyang Military Region

Status

Completed

Last Update Posted

Jun 17, 2025Actual

Enrollment

80Actual

Phase

Phase 2Phase 3

Conditions

Stroke, Ischemic

Interventions

Tenecteplase

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 21, 2023Actual

Primary Completion Date

Jun 16, 2025Actual

Completion Date

Jun 16, 2025Actual

First Submitted Date

Dec 2, 2022

First Submission Date that Met QC Criteria

Dec 10, 2022

First Posted Date

Dec 20, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 16, 2025

Last Update Posted Date

Jun 17, 2025Actual

Name	Class
Cerebrovascular Disease Collaboration & Innovation Alliance of Liaoning	UNKNOWN

Description Module

Brief Summary

The best reperfusion strategy for medium-sized vessel occlusion (MeVO) is not well established. Given the proven treatment effect of intra-arterial thrombolysis in patients with large vessel occlusion (LVO), the investigators hypothesized that intra-arterial tenecteplase (TNK) could increase the recanalization rate of MeVO and thus improve clinical outcome. The current study aimed to explore the safety and efficacy of intra-arterial TNK in patients with MeVO.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Label	Type	Description	Intervention Names
TNK group	Experimental		Drug: Tenecteplase
control group	No Intervention

Name	Type	Description	Arm Group Labels	Other Names
Tenecteplase	Drug	intra-arterial tenecteplase	TNK group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
proportion of patients with successful Medium vessel occlusion (MeVO) recanalization	successful MeVO recanalization is defined as the expanded treatment in cerebral ischemia (eTICI) score 2b67-3 in the territory of the target occluded MeVO artery	immediately after finishing intra-arterial tenecteplase

Secondary Outcomes

Measure	Description	Time Frame
proportion of modified Rankin Scale (mRS) 0-1	mRS scores range from 0 to 6, with higher scores indicating worse outcome	Day 90
proportion of modified Rankin Scale (mRS) 0-2	mRS scores range from 0 to 6, with higher scores indicating worse outcome

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age ≥18 years;
Medium vessel occlusion (MeVO), referring to M2-3 of MCA; A1-3 of ACA; P1-3 of PCA; PICA, AICA or SCA (including primary, distal embolism in the same region after thrombectomy or concurrent embolism in other regions).
- Primary MeVO as detected by the first DSA examination or secondary MeVO after mechanical thrombectomy for large vessel occlusion;
- MeVO causes neurological deficits in motor strength, language, vision etc;
- Endovascular mechanical thrombectomy cannot be performed as assessed by the investigator;
- Absence of parenchymal hematoma on CT images performed in the angio suite.
Within 24 hours from symptom onset;
Signed informed consent by patient or patient's legally authorized representative.

Exclusion Criteria:

Patients with completed infarction in the territory of the MeVO on non-contrast CT;
Patients with intracranial hemorrhage;
Coagulation disorders, tendency for systemic hemorrhagic, thrombocytopenia (<100,000/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;
After mechanical thrombectomy, severe and sustained (> 5 minutes) uncontrolled hypertension (systolic blood pressure over 180mmHg or diastolic blood pressure over 105 mmHg);
Patients with contraindication or allergy to any ingredient of study medication;
Pregnancy, plan to get pregnant or active lactation;
The estimated life expectancy is less than 6 months due to other serious diseases;
Other conditions unsuitable for this clinical study as assessed by researcher.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D020521	Stroke
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases

ID	Term
D010959	Tissue Plasminogen Activator
D012697	Serine Endopeptidases
D010450	Endopeptidases
D010447	Peptide Hydrolases