Acute Ischemic Stroke
Conditions
Keywords
Acute Ischemic Stroke, Thrombectomy, Large Intracranial Vascular Occlusion, Rescue Stenting, Randomized Controlled Trial
Brief summary
The primary objective of this study is to evaluate whether rescue stenting therapy can improve neurological functional outcomes after failed endovascular treatment for acute ischemic stroke caused by large vessel occlusion. The study population is divided into two groups: Stent Placement Group: If recanalization is not achieved after 3-5 attempts of thrombectomy, direct stent placement or balloon angioplasty is performed. Continued Thrombectomy Group: If recanalization is not achieved after 3-5 attempts of thrombectomy, at least one additional thrombectomy attempt is performed. The primary efficacy endpoint is the proportion of patients achieving a modified Rankin Scale (mRS) score of 0-2 at 90±7 days. The safety endpoint is the incidence of symptomatic intracranial hemorrhage within 48 hours after randomization.
Interventions
PROCEDUREStent placement
For patients who fail thrombectomy, perform stent placement.
PROCEDUREContinued Thrombectomy
For patients with failed thrombectomy, perform at least one additional thrombectomy attempt
PROCEDUREballoon angioplasty
For patients who fail thrombectomy, perform balloon angioplasty.
Sponsors
Beijing Anzhen Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥18 years 2. Pre-stroke mRS 0-1 3. Symptoms of AIS present within 24 hours of last known well time 4. Baseline NIHSS score ≥6 5. Anterior circulation: ASPECTS ≥6; Posterior circulation: pc-ASPECTS ≥6 6. Occlusion of intracranial ICA, M1 segment of MCA, V4 segment of vertebral artery, or basilar artery 7. Clinical care team intends to perform endovascular therapy (EVT) 8. Failure to achieve recanalization (eTICI 0-1) after 3 thrombectomy attempts, including: At least one contact aspiration attempt; At least one stent retriever attempt or combined approach 9. Subject or legally authorized representative can provide informed consent
Exclusion criteria
1. Intracranial hemorrhage confirmed by imaging prior to randomization; or intraprocedural flat-panel CT evidence of major hemorrhage 2. Gastrointestinal or genitourinary bleeding within 30 days post-stroke onset; or major surgery within 14 days 3. Bleeding diathesis, including:Laboratory evidence of coagulopathy (PLT \<100×10⁹/L, aPTT \>50 sec, or INR \>2.0); Direct oral anticoagulant (DOAC) use within 48 hours prior; History of heparin-induced thrombocytopenia (HIT) 4. Pregnancy or lactation at admission 5. Contraindications to:Radiographic contrast agents; Nickel, titanium, or their alloys (device-related) 6. Life expectancy \<6 months 7. Pre-existing neurological/psychiatric conditions that may confound neurological assessment 8. Severe renal insufficiency:GFR \<30 mL/min or Serum creatinine \>220 μmol/L (2.5 mg/dL) 9. Arterial tortuosity or other vascular anomalies preventing device delivery to target vessel 10. Unlikely to complete 90-day follow-up
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with mRS 0-2 | 90±7 days | Proportion of patients with Modified Rankin Scale (mRS) 0-2, Modified Rankin Scale（0-6）, A lower MRS score indicates better functional status for the patient. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of rescue therapy | 90±7 days | Incidence of rescue therapy |
| Change in NIHSS score from baseline | 36±12 hours post-randomization | Change in National Institute of Health stroke scale score from baseline.The NIH Stroke Scale (NIHSS) score ranges from 0 to 42 points, with lower scores indicating better neurological function |
| Vascular recanalization rate assessed by CT/MR angiography | at 36±12 hours post-randomization | Vascular recanalization rate assessed by CT/MR angiography |
| Change in infarct volume | at 7±3 days post-randomization or discharge (whichever comes first) | Change in infarct volume |
| Proportion of patients achieving mRS 0-1 | 90±7 days | Proportion of patients achieving mRS 0-1 |
| EQ-5D-5L utility score | 90±7 days | The EuroQol 5-Dimension 5-Level Utility Score (EQ-5D-5L utility score) ranges from -0.594 to 1.000 (Chinese value set), assessing health-related quality of life, with higher scores indicating better health status. |
| Probability of symptomatic intracranial hemorrhage | 48 hours | Probability of symptomatic intracranial hemorrhage |
| All-cause mortality | 90±7 days post-randomization | All-cause mortality |
| Probability of any intracranial hemorrhage (per Heidelberg criteria) | 48 hours post-randomization | Probability of any intracranial hemorrhage (per Heidelberg criteria) |
| Distribution of mRS scores | 7±3 days/discharge and 90±7 days post-randomization | Modified Rankin Scale（0-6）, A lower MRS score indicates better functional status for the patient. |
Countries
China
Outcome results
None listed