StrokeRESCUE MeVONCT07185022
Intra-arterial Thrombolysis for Acute Ischemic Stroke With Medium Vessel Occlusion
A study testing Intra-arterial Thrombolysis and Best Medical Treatment in people with Stroke and Cerebrovascular Disorders, run by The Second Hospital of Anhui Medical University at 6 sites in China.
Trial summary
Acute ischemic stroke (AIS) due to medium vessel occlusion (MeVO) or severe stenosis poses a significant clinical challenge. Recent large randomized controlled trials, DISTAL and ESCAPE-MeVO, demonstrated no significant benefit of endovascular therapy in patients with MeVO. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Cerebrovascular Disorders, Brain Diseases
- What is being tested?
- Intra-arterial Thrombolysis and Best Medical Treatment
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 282 participants
- Where
- 6 sitesChina
- Study dates
- 6 Jan 2026to 1 May 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Primary medium vessel occlusion (MeVO) or severe stenosis (≥70%) was detected on CTA, MRA, or DSA, involving arterial segments including M2-M3 of the middle cerebral artery (MCA), A1-A2 of the anterior cerebral artery (ACA), P1-P2 of the posterior cerebral artery (PCA), and the anterior inferior cerebellar artery (AICA), posterior inferior cerebellar artery (PICA), and superior cerebellar artery (SCA)
- The clinical symptoms were consistent with MeVO, with a NIHSS score 5 - 25, or an NIHSS score of 3-4 in the presence of disabling neurological deficits (e.g., hemianopia, aphasia, or motor dysfunction)
- Intra-arterial thrombolysis was administered within the following time windows:
- Acute ischemic stroke within 24 hours of symptom onset or last known well, including stroke with known onset, wake-up stroke and stroke with unknown onset, with no obvious hypodensity on CT and good collateral circulation on CTA;
- Acute ischemic stroke within 24-72 hours of onset, meeting at least one of the following imaging criteria: a.CT or MR perfusion imaging demonstrating target mismatch, defined as an ischemic core volume <30 mL, a mismatch ratio ≥1.2, and a mismatch volume ≥10 mL.; b.MRI demonstrating DWI-FLAIR mismatch, defined as the presence of acute ischemic lesions on diffusion-weighted imaging (DWI) with no corresponding hyperintense signal on FLAIR, or with FLAIR hyperintense lesions occupying less than one-third of the DWI lesion volume.
- Signed informed consent obtained
Who cannot join
- Pre-stroke mRS ≥ 2
- Secondary MeVO or severe stenosis caused by endovascular therapy
- Neuroimaging demonstrated intracranial hemorrhage, subarachnoid hemorrhage, or other hemorrhagic disorders
- Non-contrast CT demonstrating a clearly hypodense lesion corresponding to the vascular territory
- Platelet count <100 × 10⁹/L, known bleeding tendency or coagulation factor deficiency, or oral anticoagulant therapy with an international normalized ratio (INR) >3.0
- Persistent and uncontrolled hypertension, defined as systolic blood pressure >185 mmHg or diastolic blood pressure >110 mmHg
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- History of intracranial hemorrhage within the past 3 months, including parenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, epidural hemorrhage, or subdural hemorrhage
- Presence of arteriovenous malformations or brain tumors with mass effect
- Gastrointestinal or urinary tract bleeding, or major surgery within the past 3 months
- Chronic dialysis or severe renal impairment, defined as a glomerular filtration rate (GFR) <30 mL/min or serum creatinine >220 μmol/L (2.5 mg/dL)
- Patients with known allergy to thrombolytic agents or their excipients
- Patients with known allergy to iodinated contrast agents or other established contraindications
- Pregnant or current breastfeeding
- Presence of severe systemic comorbidities with a life expectancy of less than 3 months
- Deemed unsuitable for participation by the investigator for any reason
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
China6 sites, 6 recruiting
- Recruiting
Fu Yang People's Hospital
Fuyang, Anhui
Juluo Chen, 0558-3010999
Juluo Chen
- Recruiting
Lin Quan People's Hospital
Fuyang, Anhui
Susheng Long, 0558-6403761
Susheng Long
- Recruiting
The Second (Affiliated) Hospital of Anhui Medical University
Hefei, Anhui, 230031
Qi Li, professor, +8618623511778, qili_md@126.com
Qi Li, professor
- Recruiting
Lishui Central Hospital
Lishui, Zhejiang
Xiao Peng, 05782285888
Xiao Peng
- Recruiting
LiuZhou Worker's Hospital
Liuzhou, Guangxi
Xianfu Lu, 0772-3815345
Xianfu Lu
- Recruiting
Shucheng People's Hospital
Lu'an, Anhui
Jianshang Wen, 0564-8621570
Jianshang Wen
About this study
Official title: a Multicenter Prospective Randomized Controlled Trial of Intra-artErial thrombolysiS for aCUte Ischemic strokE With Medium Vessel Occlusion (RESCUE MeVO)
Acute ischemic stroke (AIS) due to medium vessel occlusion (MeVO) or severe stenosis poses a significant clinical challenge. Recent large randomized controlled trials, DISTAL and ESCAPE-MeVO, demonstrated no significant benefit of endovascular therapy in patients with MeVO. Although intra-arterial thrombolysis has shown promise in clinical experience, robust evidence supporting its efficacy in MeVO or severe stenosis-related AIS is still absent. To fill this gap, the RESCUE MeVO trial has been designed as a multicenter, prospective, randomized, open-label, blinded end-point (PROBE) study to evaluate the efficacy and safety of intra-arterial thrombolysis in patients with AIS caused by MeVO or severe stenosis.
Read the detailed description
This study is a multicenter, prospective, randomized, open-label, blinded end-point (PROBE) trial. Eligible participants will be adults (age >18 years) presenting with acute ischemic stroke (AIS) due to MeVO or severe stenosis (≥70%). Participants who meet all inclusion criteria and none of the exclusion criteria will be randomly assigned in a 1:1 ratio to one of two treatment arms. The control group will receive best medical management alone, while the intervention group will receive best medical management in combination with intra-arterial thrombolysis. Intra-arterial thrombolysis is performed by infusing rhTNK-tPA (Tenecteplase) proximal to the occlusion or severe stenosis for 5-30 minutes, with the decision to continue beyond the first 5 minutes being guided by intraprocedural DSA. The primary objective of this study is to evaluate the efficacy and safety of intra-arterial thrombolysis in patients with acute ischemic stroke caused by MeVO or severe stenosis. The primary endpoint is excellent outcome at 90 days, defined as a score of 0-1 on the modified Rankin Scale (mRS).
- Conditions
- Stroke, Cerebrovascular Disorders, Brain Diseases, Nervous System Diseases, Vascular Diseases, Ischemic Stroke
- Being tested
- Intra-arterial Thrombolysis, Best Medical Treatment
- Keywords
- Ischemic stroke, Medium vessel occlusion, Stroke, Intra-arterial thrombolysis, Severe stenosis
- Medical subject headings
- Stroke, Cerebrovascular Disorders, Brain Diseases, Nervous System Diseases, Vascular Diseases, Ischemic Stroke, Infarction, Constriction, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra-arterial ThrombolysisProcedure or surgery
rhTNK-tPA（Tenecteplase）dose: 0.4 - 1.2mg/min, maximum dose: 16mg. Patients who have not received IVT are recommended to initiate intra-arterial administration at a rate of 0.8 mg/min, whereas those who have received IVT are recommended to receive 0.4 mg/min. The infusion rate may be dynamically adjusted by the operator according to intra-procedural circumstances, with a maximum rate not exceeding 1.2 mg/min.
Best Medical TreatmentDrug
Patients in this group will receive standard medical therapy in accordance with the guideline-directed management for acute ischemic stroke.
| Study group | Role | What they receive |
|---|---|---|
| Intra-arterial Thrombolysis plus Best Medical Treatment | Experimental | Patients in this group will receive intra-arterial thrombolysis plus best medical treatment. Receives: Procedure: Intra-arterial Thrombolysis; Drug: Best Medical Treatment |
| Best Medical Treatment | Other | Patients in this group will receive standard medical therapy in accordance with the guideline-directed management for acute ischemic stroke. Receives: Drug: Best Medical Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Excellent outcome
Number of participants achieving an excellent outcome, defined as a modified Rankin Scale (mRS) score of 0-1 at 90 ± 7 days follow-up. The mRS is a widely used 7-point scale for assessing disability and functional outcomes after stroke, where higher scores represent worse outcomes.
Measured: Time Frame: 90 ± 7 days
Secondary outcomes (6)
Ordinal distribution of mRS
Ordinal distribution of the modified Rankin Scale (mRS) at 90 ± 7 days. The mRS is a widely used 7-point scale for assessing disability and functional outcomes after stroke, where higher scores represent worse outcomes.
Measured: 90 ± 7 days
Functional independence
The proportion of patients achieving functional independence, defined as a modified Rankin Scale (mRS) score of 0-2 at 90 ± 7 days follow-up. The mRS is a widely used 7-point scale for assessing disability and functional outcomes after stroke, where higher scores represent worse outcomes.
Measured: Frame: 90 ± 7 days
Poor functional outcome
Number of participants achieving a poor functional outcome, defined as a modified Rankin Scale (mRS) score of 4-6 at 90 ± 7 days follow-up. The mRS is a widely used 7-point scale for assessing disability and functional outcomes after stroke, where higher scores represent worse outcomes.
Measured: 90 ± 7 days
Early neurological deterioration
The proportion of patients with an increase of ≥ 4 points in the National Institutes of Health Stroke Scale (NIHSS) score, within 24 ± 12 hours post-randomization. The NIHSS is a standardized 11-item assessment tool designed to quantify neurological deficits in patients with acute stroke. The total score ranges from 0 to 42, with higher values indicating more severe deficits.
Measured: 24 ± 12 hours
Any neurological improvement
The proportion of patients with a reduction of ≥ 2 points in the National Institutes of Health Stroke Scale (NIHSS) score from baseline at 24 ± 12 hours post-randomization. The NIHSS is a standardized 11-item assessment tool designed to quantify neurological deficits in patients with acute stroke. The total score ranges from 0 to 42, with higher values indicating more severe deficits.
Measured: 24 ± 12 hours
Early neurological improvement
The proportion of patients with a reduction of ≥ 4 points in the National Institutes of Health Stroke Scale (NIHSS) score from baseline at 24 ± 12 hours post-randomization. The NIHSS is a standardized 11-item assessment tool designed to quantify neurological deficits in patients with acute stroke. The total score ranges from 0 to 42, with higher values indicating more severe deficits.
Measured: 24 ± 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study start6 Jan 2026
- Primary completion1 Feb 2030 (estimated)
- Study completion1 May 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 282 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Hospital of Anhui Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qi Li, The Second Hospital of Anhui Medical University
- Investigators
- Qi Li, professor, Principal investigator, The Second Hospital of Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07185022
- Sponsor's protocol ID
- YX2025-105(F1)
- Acronym
- RESCUE MeVO
- Status last verified
- Sep 2025
- First submitted
- 15 Sep 2025
- Last updated
- 16 Apr 2026
- 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 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- a Multicenter Prospective Randomized Controlled Trial of Intra-artErial thrombolysiS for aCUte Ischemic strokE With Medium Vessel Occlusion (RESCUE MeVO)
- ClinicalTrials.gov ID
- NCT07185022
- Acronym / sponsor ID
- RESCUE MeVO / YX2025-105(F1)
- Conditions
- Stroke, Cerebrovascular Disorders, Brain Diseases, Nervous System Diseases, Vascular Diseases, Ischemic Stroke
- Keywords
- Ischemic stroke, Medium vessel occlusion, Stroke, Intra-arterial thrombolysis, Severe stenosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 282 participants (estimated)
- Lead sponsor
- The Second Hospital of Anhui Medical UniversityUniversity, hospital or other
- Study start
- 6 Jan 2026 (actual)
- Primary completion
- 1 Feb 2030 (estimated)
- Study completion
- 1 May 2030 (estimated)
- First posted
- 22 Sep 2025 (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.
Acute ischemic stroke (AIS) due to medium vessel occlusion (MeVO) or severe stenosis poses a significant clinical challenge. Recent large randomized controlled trials, DISTAL and ESCAPE-MeVO, demonstrated no significant benefit of endovascular therapy in patients with MeVO. Although intra-arterial thrombolysis has shown promise in clinical experience, robust evidence supporting its efficacy in MeVO or severe stenosis-related AIS is still absent. To fill this gap, the RESCUE MeVO trial has been designed as a multicenter, prospective, randomized, open-label, blinded end-point (PROBE) study to evaluate the efficacy and safety of intra-arterial thrombolysis in patients with AIS caused by MeVO or severe stenosis.
Detailed description
This study is a multicenter, prospective, randomized, open-label, blinded end-point (PROBE) trial. Eligible participants will be adults (age >18 years) presenting with acute ischemic stroke (AIS) due to MeVO or severe stenosis (≥70%). Participants who meet all inclusion criteria and none of the exclusion criteria will be randomly assigned in a 1:1 ratio to one of two treatment arms. The control group will receive best medical management alone, while the intervention group will receive best medical management in combination with intra-arterial thrombolysis. Intra-arterial thrombolysis is performed by infusing rhTNK-tPA (Tenecteplase) proximal to the occlusion or severe stenosis for 5-30 minutes, with the decision to continue beyond the first 5 minutes being guided by intraprocedural DSA. The primary objective of this study is to evaluate the efficacy and safety of intra-arterial thrombolysis in patients with acute ischemic stroke caused by MeVO or severe stenosis. The primary endpoint is excellent outcome at 90 days, defined as a score of 0-1 on the modified Rankin Scale (mRS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intra-arterial Thrombolysis plus Best Medical Treatment | Experimental | Procedure: Intra-arterial Thrombolysis, Drug: Best Medical TreatmentPatients in this group will receive intra-arterial thrombolysis plus best medical treatment. |
| Best Medical Treatment | Other | Drug: Best Medical TreatmentPatients in this group will receive standard medical therapy in accordance with the guideline-directed management for acute ischemic stroke. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age > 18 years
- Primary medium vessel occlusion (MeVO) or severe stenosis (≥70%) was detected on CTA, MRA, or DSA, involving arterial segments including M2-M3 of the middle cerebral artery (MCA), A1-A2 of the anterior cerebral artery (ACA), P1-P2 of the posterior cerebral artery (PCA), and the anterior inferior cerebellar artery (AICA), posterior inferior cerebellar artery (PICA), and superior cerebellar artery (SCA)
- The clinical symptoms were consistent with MeVO, with a NIHSS score 5 - 25, or an NIHSS score of 3-4 in the presence of disabling neurological deficits (e.g., hemianopia, aphasia, or motor dysfunction)
- Intra-arterial thrombolysis was administered within the following time windows:
- Signed informed consent obtained
Key exclusion criteria (15 listed)
- Pre-stroke mRS ≥ 2
- Secondary MeVO or severe stenosis caused by endovascular therapy
- Neuroimaging demonstrated intracranial hemorrhage, subarachnoid hemorrhage, or other hemorrhagic disorders
- Non-contrast CT demonstrating a clearly hypodense lesion corresponding to the vascular territory
- Platelet count <100 × 10⁹/L, known bleeding tendency or coagulation factor deficiency, or oral anticoagulant therapy with an international normalized ratio (INR) >3.0
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 |
|---|---|---|
| Intra-arterial ThrombolysisrhTNK-tPA（Tenecteplase）dose: 0.4 - 1.2mg/min, maximum dose: 16mg. Patients who have not received IVT are recommended to initiate intra-arterial administration at a rate of 0.8 mg/min, whereas those who have received IVT are recommended to receive 0.4 mg/min. The infusion rate may be dynamically adjusted by the operator according to intra-procedural circumstances, with a maximum rate not exceeding 1.2 mg/min. | Procedure or surgery | Intra-arterial Thrombolysis plus Best Medical Treatment |
| Best Medical TreatmentPatients in this group will receive standard medical therapy in accordance with the guideline-directed management for acute ischemic stroke. | Drug | Best Medical Treatment, Intra-arterial Thrombolysis plus Best Medical Treatment |
Primary outcome
Excellent outcome
Time frame: Time Frame: 90 ± 7 days
Number of participants achieving an excellent outcome, defined as a modified Rankin Scale (mRS) score of 0-1 at 90 ± 7 days follow-up. The mRS is a widely used 7-point scale for assessing disability and functional outcomes after stroke, where higher scores represent worse outcomes.
6 secondary outcomes
Ordinal distribution of mRS
Time frame: 90 ± 7 days
Functional independence
Time frame: Frame: 90 ± 7 days
Poor functional outcome
Time frame: 90 ± 7 days
Early neurological deterioration
Time frame: 24 ± 12 hours
Any neurological improvement
Time frame: 24 ± 12 hours
Early neurological improvement
Time frame: 24 ± 12 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- 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.
Qi Li, professor principal investigator
The Second Hospital of Anhui Medical University
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intra-arterial Thrombolysis and Best Medical Treatment in people with Stroke and Cerebrovascular Disorders, run by The Second Hospital of Anhui Medical University at 6 sites 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 7 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qi Li, professor (+8618623511778, qili_md@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Excellent outcome (time frame: Time Frame: 90 ± 7 days). 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 16 Apr 2026.