Acute Ischemic StrokePhase 3PEARL-MeVONCT07137832
OPtimizing REperfusion by Primary Intra-Arterial ThRomboLysis for Medium Vessel Occlusion
A Phase 3 study testing Primary intra-arterial thrombolysis and Standard medical treatment in people with Acute Ischemic Stroke, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial summary
PEARL-MeVO is an investigator-initiated, multicenter, prospective, randomized controlled, open-label, blinded endpoint (PROBE) clinical trial aiming at evaluating the efficacy and safety of primary intra-arterial thrombolysis in improving 90-day functional outcome in acute ischemic stroke patients due to medium vessel… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Primary intra-arterial thrombolysis and Standard medical treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 530 participants
- Where
- 1 siteChina
- Study dates
- 9 Oct 2025to 31 Dec 2028
- Phase
- Phase 3
- 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
- Aged 18 years or older.
- Clinical diagnosis of acute ischemic stroke.
- CT angiography (CTA) or MR angiography (MRA) confirmed primary isolated medium vessel occlusion (i.e. an occlusion of the co-/non-dominant M2, the M3/M4 segment of the MCA, the A1/A2/A3 segment of the ACA, or the P1/P2/P3 segment of the PCA).
- Baseline NIHSS ≥6.
- Treatment (arterial puncture) can be initiated 5.1 Within 6 hours of last known well (LKW) OR 5.2 Within 6 to 24 hours of LKW AND evidence of salvageable brain tissue on CT perfusion or perfusion-diffusion MRI (ischemic core volume <50mL, hypo-perfused tissue volume to ischemic core volume ratio >1.4, mismatch volume >10mL). Hypo-perfused tissue is defined as Tmax >6s on CT perfusion or perfusion MRI. Ischemic core is defined as rCBF <30% on CT perfusion or ADC <620μm2/s on diffusion MRI.
- Signed informed consent.
Who cannot join
- Evidence of intracranial hemorrhage.
- Pre-stroke mRS score ≥ 2.
- Rapidly improving symptoms, in the judgment of the managing clinician that the improvement is likely to result in the patient having an NIHSS score of <6 at randomization.
- The intervention procedure is unlikely to be completed as assessed by the investigator.
- Suspected cerebral vasculitis, septic embolization, or vascular occlusion due to infective endocarditis.
- Suspected arterial dissection.
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- Severe allergy to contrast agents (non-mild rash allergy) or absolute contraindication to iodine contrast.
- Known genetic or acquired bleeding disposition or anticoagulant factors deficiency.
- Coagulation disorder with INR >1.7 or use of new oral anticoagulants within 48 hours prior to symptom onset.
- Platelet count <50×10^9/L.
- Any active or recent bleeding (gastrointestinal, urinary tract bleeding, etc.), or previous parenchymal organ surgery or biopsy in the last 1 month.
- Systolic blood pressure >185 mmHg or diastolic blood pressure >110 mmHg, refractory to treatment.
- Known severe renal insufficiency with glomerular filtration rate <30 ml/min or blood creatinine >220 μmol/L (2.5 mg/dl).
- Radiological confirmed evidence of mass effect or intracranial tumour (except small meningioma).
- Anticipated life expectancy <6 months due to advanced disease (e.g., malignancy, severe cardiopulmonary disease, etc.).
- Women who are pregnant or breastfeeding.
- Participation in other clinical trials.
- Any condition that, in the judgment of the investigator, makes the patient unsuitable for this study or where this study may impose a significant risk to the patient (e.g., inability to understand and/or comply with study procedures and/or follow-up due to psychiatric disorders, cognitive or emotional impairment).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510000
Zhenhong Deng, 86-20-81332619, dengzhh58@mail.sysu.edu.cn
Xinguang Yang, 86-20-81332619, yangxinguang0926@163.com
About this study
Official title: OPtimizing REperfusion by Primary Intra-Arterial ThRomboLysis for Medium Vessel Occlusion (PEARL-MeVO): A Multicenter, Prospective, Randomized Controlled, Open-label, Blinded-Endpoint Clinical Trial
PEARL-MeVO is an investigator-initiated, multicenter, prospective, randomized controlled, open-label, blinded endpoint (PROBE) clinical trial aiming at evaluating the efficacy and safety of primary intra-arterial thrombolysis in improving 90-day functional outcome in acute ischemic stroke patients due to medium vessel occlusion (MeVO) within 24 hours of symptom onset.
Read the detailed description
PEARL-MeVO is an investigator-initiated, multicenter, prospective, randomized controlled, open-label, blinded endpoint (PROBE) clinical trial aiming at evaluating the efficacy and safety of primary intra-arterial thrombolysis in improving 90-day functional outcome in acute ischemic stroke patients due to medium vessel occlusion (MeVO) within 24 hours of symptom onset. The primary outcome is the proportion of patients with a 90-day modified Rankin Scale (mRS) of 0-1. Eligible patients will be randomly assigned at a ratio of 1:1 into the intervention group to receive primary intra-arterial thrombolysis in addition to standard medical treatment, or the control group to receive only standard medical management. A total of 530 participants (265 per group) are anticipated to be recruited for this study.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Primary intra-arterial thrombolysis, Standard medical treatment
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary intra-arterial thrombolysisCombination product
Primary intra-arterial thrombolysis, in addition to standard medical treatment
Standard medical treatmentOther
Standard medical treatment
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Primary intra-arterial thrombolysis, in addition to standard medical treatment Receives: Combination Product: Primary intra-arterial thrombolysis |
| Control group | Active comparator | Only standard medical treatment Receives: Other: Standard medical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The modified Rankin Scale score (mRS) 0-1
The proportion of mRS 0-1 at 90 (±14) days.
Measured: 90 (±14) days
Secondary outcomes (4)
Level of disability
The shift analysis of mRS at 90 (±14) days (mRS 5 and 6 merged)
Measured: 90 (±14) days
The modified Rankin Scale score (mRS) 0-2
The proportion of mRS 0-2 at 90 (±14) days;
Measured: 90 (±14) days
Quality of life (EQ-5D-5L)
Quality of life measured by the EQ-5D-5L scale score at 90 (±14) days
Measured: 90 (±14) days
Neurologic deficit (NIHSS score) changes
The change of NIHSS score from baseline at 24 (±12) hours
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 Aug 2025
- Study start9 Oct 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 530 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yamei Tang, Principal investigator, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07137832
- Sponsor's protocol ID
- SYSKY-2025-574-02
- Acronym
- PEARL-MeVO
- Status last verified
- Aug 2026
- First submitted
- 15 Aug 2025
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The IPD will be available from the Principal Investigator upon reasonable request 6 months after the trial completion.
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OPtimizing REperfusion by Primary Intra-Arterial ThRomboLysis for Medium Vessel Occlusion (PEARL-MeVO): A Multicenter, Prospective, Randomized Controlled, Open-label, Blinded-Endpoint Clinical Trial
- ClinicalTrials.gov ID
- NCT07137832
- Acronym / sponsor ID
- PEARL-MeVO / SYSKY-2025-574-02
- Conditions
- Acute Ischemic Stroke
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 530 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 9 Oct 2025 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 22 Aug 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.
PEARL-MeVO is an investigator-initiated, multicenter, prospective, randomized controlled, open-label, blinded endpoint (PROBE) clinical trial aiming at evaluating the efficacy and safety of primary intra-arterial thrombolysis in improving 90-day functional outcome in acute ischemic stroke patients due to medium vessel occlusion (MeVO) within 24 hours of symptom onset.
Detailed description
PEARL-MeVO is an investigator-initiated, multicenter, prospective, randomized controlled, open-label, blinded endpoint (PROBE) clinical trial aiming at evaluating the efficacy and safety of primary intra-arterial thrombolysis in improving 90-day functional outcome in acute ischemic stroke patients due to medium vessel occlusion (MeVO) within 24 hours of symptom onset. The primary outcome is the proportion of patients with a 90-day modified Rankin Scale (mRS) of 0-1. Eligible patients will be randomly assigned at a ratio of 1:1 into the intervention group to receive primary intra-arterial thrombolysis in addition to standard medical treatment, or the control group to receive only standard medical management. A total of 530 participants (265 per group) are anticipated to be recruited for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Combination Product: Primary intra-arterial thrombolysisPrimary intra-arterial thrombolysis, in addition to standard medical treatment |
| Control group | Active comparator | Other: Standard medical treatmentOnly standard medical treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged 18 years or older.
- Clinical diagnosis of acute ischemic stroke.
- CT angiography (CTA) or MR angiography (MRA) confirmed primary isolated medium vessel occlusion (i.e. an occlusion of the co-/non-dominant M2, the M3/M4 segment of the MCA, the A1/A2/A3 segment of the ACA, or the P1/P2/P3 segment of the PCA).
- Baseline NIHSS ≥6.
- Treatment (arterial puncture) can be initiated 5.1 Within 6 hours of last known well (LKW) OR 5.2 Within 6 to 24 hours of LKW AND evidence of salvageable brain tissue on CT perfusion or perfusion-diffusion MRI (ischemic core volume <50mL, hypo-perfused tissue volume to ischemic core volume ratio >1.4, mismatch volume >10mL). Hypo-perfused tissue is defined as Tmax >6s on CT perfusion or perfusion MRI. Ischemic core is defined as rCBF <30% on CT perfusion or ADC <620μm2/s on diffusion MRI.
Key exclusion criteria (18 listed)
- Evidence of intracranial hemorrhage.
- Pre-stroke mRS score ≥ 2.
- Rapidly improving symptoms, in the judgment of the managing clinician that the improvement is likely to result in the patient having an NIHSS score of <6 at randomization.
- The intervention procedure is unlikely to be completed as assessed by the investigator.
- Suspected cerebral vasculitis, septic embolization, or vascular occlusion due to infective endocarditis.
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 |
|---|---|---|
| Primary intra-arterial thrombolysisPrimary intra-arterial thrombolysis, in addition to standard medical treatment | Combination product | Intervention group |
| Standard medical treatmentStandard medical treatment | Other | Control group |
Primary outcome
The modified Rankin Scale score (mRS) 0-1
Time frame: 90 (±14) days
The proportion of mRS 0-1 at 90 (±14) days.
4 secondary outcomes
Level of disability
Time frame: 90 (±14) days
The modified Rankin Scale score (mRS) 0-2
Time frame: 90 (±14) days
Quality of life (EQ-5D-5L)
Time frame: 90 (±14) days
Neurologic deficit (NIHSS score) changes
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 24 Aug 2026.
- Individual participant dataSharing planned: Yes. The IPD will be available from the Principal Investigator upon reasonable request 6 months after the trial completion.
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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.
Yamei Tang principal investigator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Primary intra-arterial thrombolysis and Standard medical treatment in people with Acute Ischemic Stroke, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University 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 6 inclusion and 18 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 24 Aug 2026. 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 phase mean?
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?
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 Zhenhong Deng (86-20-81332619, dengzhh58@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The modified Rankin Scale score (mRS) 0-1 (time frame: 90 (±14) 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 24 Aug 2026.