Actively Recruiting
Evaluation of Endovascular Treatment in Acute Intracranial Distal Medium Vessel Occlusion Stroke
Led by The First Affiliated Hospital of University of Science and Technology of China · Updated on 2024-09-05
564
Participants Needed
1
Research Sites
115 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Rationale: Distal Medium Vessel Occlusion (MeVO) are thought to cause as many as 25% to 40% of all acute ischemic strokes (AIS). Despite their relatively high frequency, there is no consensus regarding the optimal management of these patients. However, the fact that AIS related to MeVO often results in significant disability despite best medical treatment (including intravenous thrombolysis, IVT) calls for novel treatment approaches. Fortunately, a growing number of non-randomized studies have now been published demonstrating the feasibility of endovascular treatment (EVT) for MeVO strokes. These studies have demonstrated that distal EVT leads to high rates of successful reperfusion and may be performed with a comparable safety profile to that of EVT for proximal arterial occlusions. Therefore, a strong rational exists to test the safety and efficacy of EVT for MeVO stokes in a prospective randomized clinical trial. Objectives: The primary objective of this study is to evaluate the hypothesis that endovascular thrombectomy is superior to standard medical management in achieving more favorable outcomes according to the modified Rankin Scale scores at 90 days in subjects presenting with acute ischemic stroke related to a distal medium vessel occlusion within 24 hours from symptom onset (defined as time last know well, TLKW). Secondary objectives include the assessment of the cost-effectiveness of endovascular thrombectomy in the medium vessel occlusion (MeVO) population as well as its impact on health-related quality of life. Study design: The study is a prospective, multicenter, investigational, randomized, controlled, open-label study with blinded endpoint evaluation (PROBE design) and an adaptive design with population enrichment. Study population: Subjects presenting with acute ischemic stroke within 24 hours from TLKW and whose strokes are attributable to a distal medium vascular occlusion defined as co/non-dominant M2 segment or M3 segment of the MCA, the ACA (A1, A2, or A3 segments), or the PCA (P1, P2 or P3 segments) with evidence of salvageable brain tissue on perfusion imaging, M2 segment vessel diameter should not exceed 2.0 mm. Primary outcome: Shift in distribution of all levels of the 90-day the modified Rankin Scale with levels 5-6 combined (mRS; 0, 1, 2, 3, 4, 5-6) as assessed by structured assessment.
CONDITIONS
Official Title
Evaluation of Endovascular Treatment in Acute Intracranial Distal Medium Vessel Occlusion Stroke
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older with no upper age limit
- Evidence of primary distal medium vessel occlusion in specific brain artery segments (co/non-dominant M2 or M3 segments of MCA, ACA segments A1, A2, or A3, or PCA segments P1, P2, or P3) with expected clinical deficits treatable by thrombectomy
- Co/non-dominant M2 segment vessel diameter not exceeding 2.0 mm
- Premorbid modified Rankin Scale (mRS) score of 2 or less
- Baseline National Institutes of Health Stroke Scale (NIHSS) score of 6 or higher at randomization
- Time from symptom onset or last seen well to randomization less than 24 hours
- For patients with more than 6 hours from onset, specific clinical-imaging mismatch criteria must be met
- Informed consent obtained from patient or acceptable surrogate
You will not qualify if you...
- Any intracranial hemorrhage on baseline CT or MRI (including subdural hematoma, subarachnoid hemorrhage, or intracerebral hemorrhage)
- Rapidly improving symptoms likely to result in NIHSS score below 6 at randomization
- Significant ischemic changes outside the occluded area that may reduce benefit of treatment
- Contraindications to MR or CT imaging with contrast
- Terminal illness with life expectancy less than 1 year
- Recent or current intracranial hemorrhage, arteriovenous malformation, aneurysm, or brain tumor other than meningioma
- Imaging findings suggesting futile recanalization
- Seizures at stroke onset preventing accurate NIHSS assessment
- Baseline blood glucose below 50 mg/dL or above 400 mg/dL
- Known bleeding disorders or platelet count below 50 x10^9/L
- Known renal failure with serum creatinine above 260 umol/l
- Suspected septic embolus or bacterial endocarditis
- Any other condition posing risk or affecting study participation if endovascular treatment performed
- History of drug or alcohol dependence interfering with study adherence
- Occlusions in multiple vascular territories
- Participation in other investigational studies impacting this trial
- Known pregnancy
- Prisoner or incarceration
AI-Screening
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Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of University of Science and Technology of China
Hefei, Anhui, China, 230001
Actively Recruiting
Research Team
W
Wei Hu, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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