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The primary objective of this study is to evaluate whether rescue balloon angioplasty versus stenting for residual stenosis following endovascular therapy improves neurological outcomes in patients with acute large vessel occlusion due to large-artery atherosclerosis. Patients will be randomized into two groups: the balloon angioplasty group receiving balloon treatment alone followed by standard medical therapy, and the stent group receiving stenting treatment with post-procedural standard medical therapy. The primary efficacy endpoint is the proportion of patients achieving functional independence (modified Rankin Scale 0-2) at 90±7 days, while the safety endpoint is the probability of symptomatic intracranial hemorrhage occurring within 48 hours after randomization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Balloon Group | Experimental | Balloon angioplasty followed by standard medical therapy post-procedure |
|
| Stent Group | Active Comparator | Stenting treatment, followed by standard medical therapy after the endovascular treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| balloon angioplasty | Procedure | Balloon angioplasty treatment followed by standard medical therapy post-procedure. |
|
| 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 |
|---|---|---|
| Vascular recanalization rate assessed by CT/MR angiography | Vascular recanalization rate assessed by CT/MR angiography | 36±12 hours post-randomization |
| 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 |
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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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| Stent | Procedure | Patients will receive either balloon-assisted stenting or direct stenting, followed by standard medical therapy after the endovascular treatment. |
|
| 36±12 hours post-randomization |
| Change in infarct volume | Change in infarct volume | 7±3 days post-randomization or discharge |
| Distribution of mRS scores | Modified Rankin Scale(0-6), A lower MRS score indicates better functional status for the patient. | 7±3 days/discharge; 90±7 days post-randomization |
| Proportion of patients achieving mRS 0-1 | Proportion of patients achieving mRS 0-1, Modified Rankin Scale(0-6), A lower MRS score indicates better functional status for the patient. | 90±7 days |
| Proportion of patients achieving mRS 0-3 | Proportion of patients achieving mRS 0-3 | 90±7 days |
| Incidence of Pharmacologic rescue therapy | Incidence of Pharmacologic rescue therapy | 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 |
| Symptomatic intracranial hemorrhage | Symptomatic intracranial hemorrhage (Heidelberg Standards) | 48 hours |
| All-cause mortality | All-cause mortality | 90±7 days |
| Probability of any intracranial hemorrhage | Probability of any intracranial hemorrhage (Heidelberg Standards) | 48 hours post-randomization |
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000800 | Angioplasty, Balloon |
| D015607 | Stents |
| ID | Term |
|---|---|
| D017130 | Angioplasty |
| D002404 | Catheterization |
| D013812 | Therapeutics |
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
| D008919 | Investigative Techniques |
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
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