Evaluation of Endovascular Treatment in Acute Intracranial Distal Medium Vessel Occlusion Stroke (NCT06146790) | Clinical Trial Compass
RecruitingNot Applicable
Evaluation of Endovascular Treatment in Acute Intracranial Distal Medium Vessel Occlusion Stroke
China564 participantsStarted 2023-12-14
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age ≥18 years (no upper age limit).
✓. Evidence of a primary (e.g., not secondary to EVT of proximal vessel occlusion) distal medium vascular occlusion defined as occlusion of the 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) resulting in significant clinical deficits and expected to be treatable by endovascular thrombectomy.
✓. Premorbid mRS ≤ 2.
✓. Baseline National Institutes of Health Stroke Scale (NIHSS) score ≥6 at the time of randomization.
✓. Time from onset (or time last seen well) to randomization\<24 hours.
✓. For patients with more than 6 hours of onset (or time last seen well), Clinical-Imaging mismatch assessment defined as any of the following scenarios (A or B):
✓. Informed consent obtained from patient or acceptable patient surrogate.
Exclusion criteria
✕. Any sign of intracranial hemorrhage on baseline CT/MR (SDH/SAH/ICH).
What they're measuring
1
The 90-day modified Rankin Scale (mRS)
Timeframe: 90 (± 14 days) after procedure
Trial details
NCT IDNCT06146790
SponsorThe First Affiliated Hospital of University of Science and Technology of China
. Rapidly improving symptoms, particularly if 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.
✕. 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.
✕. 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.
✕. seizures at stroke onset if it precludes obtaining an accurate baseline NIHSS.