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New treatment option for Ischemic Stroke
Official title Combined Thrombectomy for Distal MediUm Vessel Occlusion StroKe
ClinicalTrials.gov ID: NCT05983757
What this study is testing
- What it's testing
- A phase III, randomized, multi-center, investigational, open label clinical trial that will examine whether treatment with endovascular thrombectomy is superior to standard medical therapy alone in patients who suffer a Distal Medium Vessel Occlusion Ischemic Stroke within 12 hours from time last seen well
- 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 (no upper age limit)
- Acute ischemic stroke where patient is ineligible for or has failed\ IV thrombolytic treatment and is ineligible for endovascular treatment under...
- Evidence of a primary (e.g. not secondary to EVT of proximal vessel occlusion) distal medium vascular occlusion defined as occlusion of the...
- No significant pre-stroke functional disability (mRS ≤2)
- Evidence of a disabling stroke defined as follows:
You likely can't join if
- Any sign of intracranial hemorrhage on baseline CT/MR (SDH/SAH/ICH).
- Rapidly improving symptoms, particularly if in the judgment of the managing clinician that the improvement is likely to result in the patient having...
- Significant ischemic changes in a territory other than the occluded site that in the opinion of the investigator could reduce the benefit of...
- Contra indication to imaging with MR or CT with contrast agents.
- Infarct core \>1/3 occluded territory (MCA, ACA, or PCA) qualitatively or \>50 mL quantitatively (determined by NCCT, CTP or DWI).
- Any terminal illness such that patient would not be expected to survive more than 1 year.
See the full eligibility criteria
Who can join
- Age ≥18 years (no upper age limit)
- Acute ischemic stroke where patient is ineligible for or has failed\ IV thrombolytic treatment and is ineligible for endovascular treatment under best guideline-based care due to absence of proximal arterial occlusion...
- Evidence of a primary (e.g. not secondary to EVT of proximal vessel occlusion) distal medium vascular occlusion defined as occlusion of the non-dominant M2 segment or M3 segment of the MCA, the ACA (A1, A2, or A3...
- No significant pre-stroke functional disability (mRS ≤2)
- Evidence of a disabling stroke defined as follows:
- Baseline National Institutes of Health Stroke Scale (NIHSS) score \>5 at the time of randomization.
- NIHSS 3-5 with disabling deficit including significant aphasia, neglect, hemianopsia, or hemiparesis/ loss of hand or leg function as established by the treating team in context of the patient's life.
- The presence of a Target Mismatch defined as:
- Ischemic Core \< 50cc (defined on NCCT/CTP\ or DWI-MRI) \ Visual or automatedly detected hypodensity on NCCT should be used to exclude or include patients if the investigator believes that their assessment is more...
- Mismatch Volume (TMax \>6sec lesion - Core volume lesion) \>10cc
- Mismatch Ratio \>1.4
- Patient treatable within 12 hours of symptom onset. Symptoms onset is defined as the point in time the patient was last seen well (at baseline). Treatment start is defined as the time of arterial puncture.
- Informed consent obtained from patient or acceptable patient surrogate
What rules you out
- Any sign of intracranial hemorrhage on baseline CT/MR (SDH/SAH/ICH).
- Rapidly improving symptoms, particularly if in the judgment of the managing clinician that the improvement is likely to result in the patient having no residual disabling deficits and an NIHSS score of \<5 at...
- Significant ischemic changes in a territory other than the occluded site that in the opinion of the investigator could reduce the benefit of endovascular treatment.
- Contra indication to imaging with MR or CT with contrast agents.
- Infarct core \>1/3 occluded territory (MCA, ACA, or PCA) qualitatively or \>50 mL quantitatively (determined by NCCT, CTP or DWI).
- Any terminal illness such that patient would not be expected to survive more than 1 year.
- Recent past history or clinical presentation of ICH, subarachnoid hemorrhage (SAH), arterio-venous (AV) malformation, aneurysm, or cerebral neoplasm other than meningioma.
- Any imaging findings suggestive of futile recanalization in the judgment of the local investigator.
- Premorbid disability (mRS ≥3).
- Inability to initiate endovascular treatment within 12 hours of last seen well.
- Seizures at stroke onset if it precludes obtaining an accurate baseline NIHSS.
- Baseline blood glucose of \ 400 mg/dL (22.20 mmol).
- Known history of hereditary or acquired hemorrhagic diathesis and/or platelet count \<100,000/uL.
- Known renal failure as defined as serum creatinine levels \> 3.0 mg/dL.
- Presumed septic embolus or suspicion of bacterial endocarditis.
- Any other condition that, in the opinion of the investigator, precludes an endovascular procedure or poses a significant hazard to the subject if an endovascular procedure was performed.
- History of drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
- people with occlusions in multiple vascular territories (e.g., bilateral or multi-territorial anterior circulation, or anterior/posterior circulation)
- Subject participating in a study involving an investigational drug or device that would impact this study
- Known pregnancy
- Prisoner or incarceration
- Known acute symptomatic COVID-19 infection
The study team makes the final eligibility decision.
Where it's taking place
- Atlanta, Georgia, United States
- Iowa City, Iowa, United States
- Toledo, Ohio, United States
- Pittsburgh, Pennsylvania, United States
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 Atlanta, Georgia, United States; Iowa City, Iowa, United States; Toledo, Ohio, United States; Pittsburgh, Pennsylvania, United States. 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.