Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Fujian Medical University Union Hospital | OTHER |
| Zhangzhou Affiliated Hospital of Fujian Medical University | OTHER |
Not provided
Not provided
Not provided
To investigate whether using balloon guide catheter with flow arrest during mechanical thrombectomy, compared to non-flow arrest, improves the rate of first pass expanded Thrombolysis in Cerebral Infarction score (eTICI 2c-3) reperfusion for acute ischemic stroke due to internal carotid artery occlusion
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The experimental group | Experimental |
| |
| The control group | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Balloon guide catheter combined with conventional thrombectomy treatment | Procedure | The experimental group will use balloon guide catheter combined with conventional thrombectomy treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of first-pass reperfusion defined as eTICI 2c-3 reperfusion | Perioperative |
| Measure | Description | Time Frame |
|---|---|---|
| Good outcome proportion, defined as mRS score 0-2 | 90 days (±7 days) post-procedure | |
| Ordinal Distribution of mRS Scores (mRS Shift analysis) | 90 days (±7 days) | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fujian Medical University Union Hospital | Recruiting | Fuzhou | Fujian | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Standard guide catheter or neurovascular sheath combined with conventional thrombectomy treatment | Procedure | use standard guide catheter or neurovascular sheath combined with conventional thrombectomy treatment |
|
| Change in stroke severity (NIHSS score) |
| 7 days or discharge (whichever occurs first); |
| Technical success rate | Defined as the successful delivery of the guiding catheter to the target vessel and completion of the thrombectomy process without replacing the guiding catheter | Perioperative |
| Final angiographic reperfusion results (eTICI ≥2b, eTICI ≥2c, eTICI 3) | Perioperative |
| Reperfusion results (eTICI ≥2b, eTICI 3) | Perioperative |
| Time from groin puncture to successful reperfusion (eTICI ≥2b, eTICI ≥2c); | Perioperative |
| Number of mechanical thrombectomy attempts | Perioperative |
| EQ-5D-5L score | 90 ± 7 days after surgery |
| Proportion of participants with a Barthel Index score of ≥95 | 90 ± 7 days after surgery |
| Zhangzhou Municipal Hospital | Recruiting | Zhangzhou | Fujian | China |
|
| Xuanwu Hospital, Capital Medical University. | Recruiting | Beijing | 100053 | China |
|
| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided