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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stenting or Angioplasty Group | Experimental | If recanalization is not achieved after 3-5 attempts of thrombectomy, direct stent placement or balloon angioplasty is performed. |
|
| Continued Thrombectomy Group | Active Comparator | If recanalization is not achieved after 3-5 attempts of thrombectomy, at least one additional thrombectomy attempt is performed |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stent placement | Procedure | For patients who fail thrombectomy, perform stent placement. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with mRS 0-2 | 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. | 90±7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change in NIHSS score from baseline | 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 | 36±12 hours post-randomization |
| Vascular recanalization rate assessed by CT/MR angiography |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Anzhen Hospital Affiliated to Capital Medical University | Beijing | Beijing Municipality | 101118 | China |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D000800 | Angioplasty, Balloon |
| ID | Term |
|---|---|
| D017130 | Angioplasty |
| D002404 | Catheterization |
| D013812 | Therapeutics |
| D057510 | Endovascular Procedures |
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| Continued Thrombectomy | Procedure | For patients with failed thrombectomy, perform at least one additional thrombectomy attempt |
|
| balloon angioplasty | Procedure | For patients who fail thrombectomy, perform balloon angioplasty. |
|
Vascular recanalization rate assessed by CT/MR angiography |
| at 36±12 hours post-randomization |
| Change in infarct volume | Change in infarct volume | at 7±3 days post-randomization or discharge (whichever comes first) |
| Distribution of mRS scores | Modified Rankin Scale(0-6), A lower MRS score indicates better functional status for the patient. | 7±3 days/discharge and 90±7 days post-randomization |
| Proportion of patients achieving mRS 0-1 | Proportion of patients achieving mRS 0-1 | 90±7 days |
| Incidence of rescue therapy | Incidence of rescue therapy | 90±7 days |
| EQ-5D-5L utility score | 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. | 90±7 days |
| Probability of symptomatic intracranial hemorrhage | Probability of symptomatic intracranial hemorrhage | 48 hours |
| All-cause mortality | All-cause mortality | 90±7 days post-randomization |
| Probability of any intracranial hemorrhage (per Heidelberg criteria) | Probability of any intracranial hemorrhage (per Heidelberg criteria) | 48 hours post-randomization |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D014656 |
| Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
| D008919 | Investigative Techniques |