Stroke, IschemicPhase 2/3NCT05657470
Rescue Thrombolysis for Medium Vessel Occlusion (RESCUE-TNK)
A Phase 2/3 study testing Tenecteplase in people with Stroke, Ischemic, run by General Hospital of Shenyang Military Region at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Ischemic
- What is being tested?
- Tenecteplase
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 21 Mar 2023to 16 Jun 2025
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Rescue Thrombolysis for Medium Vessel Occlusion (RESCUE-TNK): a Prospective, Randomized, Open-label, Blinded End Point, and Multicenter Trial
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.
- Conditions
- Stroke, Ischemic
- Being tested
- Tenecteplase
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TenecteplaseDrug
intra-arterial tenecteplase
| Study group | Role | What they receive |
|---|---|---|
| TNK group | Experimental | Not described Receives: Drug: Tenecteplase |
| control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: immediately after finishing intra-arterial tenecteplase
Secondary outcomes (11)
proportion of modified Rankin Scale (mRS) 0-1
mRS scores range from 0 to 6, with higher scores indicating worse outcome
Measured: Day 90
proportion of modified Rankin Scale (mRS) 0-2
mRS scores range from 0 to 6, with higher scores indicating worse outcome
Measured: Day 90
distribution of modified Rankin Scale (mRS)
mRS scores range from 0 to 6, with higher scores indicating worse outcome
Measured: Day 90
incidence of early neurological improvement
early neurological improvement is defined as a decrease of more than 4 points or reaching 0 points in NIHSS score, compared with baseline
Measured: 24 (-6/+24) hours
Changes in National Institute of Health stroke scale (NIHSS)
NIHSS scores range 0-42, with higher scores indicating greater stroke severity
Measured: 24 (-6/+24) hours
rate of visual recovery in patients with posterior cerebral artery occlusion
Measured: 7 days or at hospital discharge
proportion of symptomatic intracranial hemorrhage
symptomatic intracranial hemorrhage is defined as an increase in the NIHSS score of ≥4 points as a result of the intracranial hemorrhage
Measured: 24 (-6/+24) hours
proportion of parenchymal hematoma type 1 and 2
Measured: 24 (-6/+24) hours
all serious adverse events
Measured: 24 (-6/+24) hours
all-cause death
Measured: 7 days
recurrent stroke, cardiovascular events, other vascular events and death
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2022
- Study start21 Mar 2023
- Primary completion16 Jun 2025
- Study completion16 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, IschemicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- General Hospital of Shenyang Military Region
- Sponsor type
- University, hospital or other
- Collaborators
- Cerebrovascular Disease Collaboration & Innovation Alliance of Liaoning
- Responsible party
- Principal investigator, Hui-Sheng Chen, General Hospital of Shenyang Military Region
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05657470
- Sponsor's protocol ID
- Y (2022) 187
- Status last verified
- Jun 2025
- First submitted
- 2 Dec 2022
- Last updated
- 17 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rescue Thrombolysis for Medium Vessel Occlusion (RESCUE-TNK): a Prospective, Randomized, Open-label, Blinded End Point, and Multicenter Trial
- ClinicalTrials.gov ID
- NCT05657470
- Acronym / sponsor ID
- Y (2022) 187
- Conditions
- Stroke, Ischemic
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- General Hospital of Shenyang Military RegionUniversity, hospital or other
- Collaborators
- Cerebrovascular Disease Collaboration & Innovation Alliance of Liaoning
- Study start
- 21 Mar 2023 (actual)
- Primary completion
- 16 Jun 2025 (actual)
- Study completion
- 16 Jun 2025 (actual)
- First posted
- 20 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TNK group | Experimental | Drug: Tenecteplase |
| control group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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).
- Within 24 hours from symptom onset;
- Signed informed consent by patient or patient's legally authorized representative.
Key exclusion criteria (9 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tenecteplaseintra-arterial tenecteplase | Drug | TNK group |
Primary outcome
proportion of patients with successful Medium vessel occlusion (MeVO) recanalization
Time frame: immediately after finishing intra-arterial tenecteplase
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
11 secondary outcomes
proportion of modified Rankin Scale (mRS) 0-1
Time frame: Day 90
proportion of modified Rankin Scale (mRS) 0-2
Time frame: Day 90
distribution of modified Rankin Scale (mRS)
Time frame: Day 90
incidence of early neurological improvement
Time frame: 24 (-6/+24) hours
Changes in National Institute of Health stroke scale (NIHSS)
Time frame: 24 (-6/+24) hours
rate of visual recovery in patients with posterior cerebral artery occlusion
Time frame: 7 days or at hospital discharge
proportion of symptomatic intracranial hemorrhage
Time frame: 24 (-6/+24) hours
proportion of parenchymal hematoma type 1 and 2
Time frame: 24 (-6/+24) hours
all serious adverse events
Time frame: 24 (-6/+24) hours
all-cause death
Time frame: 7 days
recurrent stroke, cardiovascular events, other vascular events and death
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Tenecteplase in people with Stroke, Ischemic, run by General Hospital of Shenyang Military Region at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
proportion of patients with successful Medium vessel occlusion (MeVO) recanalization (time frame: immediately after finishing intra-arterial tenecteplase). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2025.