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 |
|---|---|
| Henan provincial interventional therapy center | UNKNOWN |
| Henan Provincial People's Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To evaluate whether recanalization and stenting for symptomatic subacute and chronic veterbrobasilar artery occlusion is technically feasible, can prevent from recurrent ischemic events and promotes functional recovery of disability.
Ischemic stroke accounts for 87% of cerebrovascular accidents. Of these, a part is the result of intracranial veterbrobasilar occlusion. Acute veterbrobasilar artery occlusion is a devastating disease with high mortality without successful treatment. A subset of patients can survive the acute phase and develop subacute or chronic veterbrobasilar artery occlusion. Due to the adequacy of collaterals, some patients can live without any or just very mild symptoms. On the contrast, lack of enough collaterals, another patients still presented with recurrent ischemic events and progressive disability despite intensive medical therapy. Prognosis is extremely poor. It is in this cohort that subacute or chronic revascularization is often considered. The optimal treatment in this cohort with non-acute veterbrobasilar artery occlusion is unknown, and there is little literature to guide therapy. Extracranial-intracranial bypass may revascularize the intracranial artery occlusion. However, bypass procedures are technically challenging and are associated with significant risk of morbidity and mortality. Recurrent ischemic symptoms despite best medical treatment be indication for endovascular revascularization and stent remodeling. This study was to evaluate the technical feasibility, safety and treatment effects of recanalization and stenting for veterbrobasilar subacute-chronic intracranial artery occlusion。
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| recanalization and stenting | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| stenting | Device | Apollo stent (MicroPort Medical, China),Neuroform stent (Stryker/Boston Scientific, USA) or Wingspan stent (Stryker/Boston Scientific, USA), et al. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Modified Rankin Scale at Six Months postoperative | Modified Rankin Scale (mRS) was used to evaluate the level of disability | six months to two years |
| Changes from Baseline in Modified Rankin Scale (mRS) at one year postoperative | one to three years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events |
| up to three years |
| Changes from Baseline in NIHSS (National Institutes of Health Stroke Scale) at Six Months postoperative |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Tianxiao Li, MD. PhD | Henan provincial intervention therapy center | Study Chair |
| Ziliang Wang, MD | Henan Provincial People's Hospital | Study Director |
| Yingkun He, MD. | Henan Provincial People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henan Provincial People'S Hospital | Zhengzhou | Henan | 450003 | China | ||
| Henan provincial intervention therapy center |
Not provided
| ID | Term |
|---|---|
| D020521 | Stroke |
| D001733 | Bites and Stings |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D015607 | Stents |
| ID | Term |
|---|---|
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
NIHSS (National Institutes of Health Stroke Scale) is used to evaluate the severity of neurological deficit. |
| six months to two years |
| Rate of Successful Recanalization | Antegrade blood flow through the recanalized portion was assessed by thrombolysis in myocardial infarction (TIMI) score or thrombolysis in cerebral infarction (TICI) score. TIMI≥2 or TICI≥2b was defined as successful recanalization. | two years |
| Changes from Baseline in BI (Barthel Index) at Six Months postoperative | BI (Barthel Index) is used to evaluate activities of daily living. | six months to two years |
| Changes from Baseline in WHOQOL-BREF (The World Health Organization Quality of Life - BREF)at Six Months postoperative | WHOQOL-BREF (The World Health Organization Quality of Life - BREF) is used to evaluate the individual's perceptions in the context of their culture and value systems, and their personal goals, standards and concerns. | six months to two years |
| Zhengzhou |
| Henan |
| China |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D011041 | Poisoning |
| D064419 | Chemically-Induced Disorders |
| D014947 | Wounds and Injuries |