BridgeMD
New treatment option for Acute Ischemic Stroke
Official title Large Artery Occlusion Treated in Extended Time With Mechanical Thrombectomy Trial
ClinicalTrials.gov ID: NCT05326932
What this study is testing
- What it's testing
- A multi-center, prospective, randomized, open-label, adaptive group sequential designed, blinded endpoint assessment (PROBE) clinical trial of endovascular treatment among selected AIS
- 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
- Present 24-72 hours of stroke onset or last seen well
- Clinical diagnosis of AIS due to anterior circulation LVO (from internal carotid artery (ICA) extracranial segment to middle cerebral artery (MCA) M1...
- National Institute of Health stroke scale (NIHSS) ≥6 at randomisation
- Viable cerebral tissue on computerized tomography perfusion (CTP) assessed: infarct core volume \<50 mL, mismatch ratio ≥1.8, and mismatch volume ≥15...
You likely can't join if
- Clinical Exclusion Criteria
- Considered unlikely to benefit from trial (e.g. advanced dementia, major pre-stroke disability (prior modified Rankins scale (mRS) ≥2), high...
- Major co-morbid disease that could interfere with outcome assessments and follow-up (e.g. cancer, severe heart failure, kidney failure)
- Pregnancy
- Unable to undergo a CTP
- Known allergy to iodine, heparin, anaesthesia, or other definite contraindication to receiving endovascular treatment (EVT) procedure
See the full eligibility criteria
- Age ≥18 years
- Present 24-72 hours of stroke onset or last seen well
- Clinical diagnosis of AIS due to anterior circulation LVO (from internal carotid artery (ICA) extracranial segment to middle cerebral artery (MCA) M1 and M2 segment) on brain imaging
- National Institute of Health stroke scale (NIHSS) ≥6 at randomisation
- Viable cerebral tissue on computerized tomography perfusion (CTP) assessed: infarct core volume \<50 mL, mismatch ratio ≥1.8, and mismatch volume ≥15 mL
- Written informed consent (by patient or proxy, according to local requirements)
- Clinical Exclusion Criteria
- Considered unlikely to benefit from trial (e.g. advanced dementia, major pre-stroke disability (prior modified Rankins scale (mRS) ≥2), high likelihood of early death), as judged by the responsible treating clinician
- Major co-morbid disease that could interfere with outcome assessments and follow-up (e.g. cancer, severe heart failure, kidney failure)
- Pregnancy
- Unable to undergo a CTP
- Known allergy to iodine, heparin, anaesthesia, or other definite contraindication to receiving endovascular treatment (EVT) procedure
- Seizures at stroke onset or before randomization and baseline NIHSS scores cannot be accurately determined
- Baseline blood glucose of \ 400 mg/dL (22.20 mmol/L)
- Baseline platelet count \< 50,000/uL
- Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency; recent oral anticoagulant therapy with International normalized ratio (INR) \>3
- Severe, sustained hypertension that can not be controlled by medication (systolic BP \>220 mmHg or diastolic BP \>120 mmHg)
- Presumed septic embolus, suspicion of bacterial endocarditis
- EVT attempted after stroke onset
- Unlikely to participate in follow-up assessments
- Currently participating in another trial that may affect outcomes.
- Any other condition that, in the opinion of the investigator will pose a significant hazard to the subject if participating in the trial. Neuroimaging Exclusion Criteria
- Intracranial hemorrhage (ICH), including parenchymal hemorrhage, ventricular hemorrhage, subarachnoid hemorrhage, and subdural/exsanguination
- Evidence of intracranial malignant tumor
- Significant mass effect with midline shift
- Aortic dissection
- Intracranial stent implanted in the same vascular territory
- Any other condition that may affect EVT procedure, like the tortuous vascular path the device is difficult to reach the target position or difficult to recover
- Occlusions in multiple vascular territories confirmed on Computerized tomography angiography (CTA)/ Magnetic resonance imaging angiography (MRA) (e.g. bilateral MCA occlusions, or an MCA and a basilar artery occlusion)
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, 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 Shanghai, 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.