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New treatment option for Stroke
Official title Intra-arterial Thrombolysis for Acute Ischemic Stroke With Medium Vessel Occlusion
ClinicalTrials.gov ID: NCT07185022
What this study is testing
What is Best Medical Treatment?
Best Medical Treatment is an investigational medicine, being studied as a potential treatment for stroke.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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...
- 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...
You likely can't join if
- 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 \ 3.0
- Persistent and uncontrolled hypertension, defined as systolic blood pressure \>185 mmHg or diastolic blood pressure \>110 mmHg
See the full eligibility criteria
- 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...
- 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...
- 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...
- Signed informed consent obtained
- 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 \ 3.0
- Persistent and uncontrolled hypertension, defined as systolic blood pressure \>185 mmHg or diastolic blood pressure \>110 mmHg
- 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) \ 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
The study team makes the final eligibility decision.
Where it's taking place
- Fuyang, Anhui, China
- Hefei, Anhui, China
- Lu'an, Anhui, China
- Liuzhou, Guangxi, China
- Lishui, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fuyang, Anhui, China; Hefei, Anhui, China; Lu'an, Anhui, China; Liuzhou, Guangxi, China; Lishui, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.