Recanalization and Stenting for Non-acute Veterbrobasilar Artery Occlusion
|ClinicalTrials.gov Identifier: NCT01632865|
Recruitment Status : Completed
First Posted : July 3, 2012
Last Update Posted : January 25, 2017
|Condition or disease||Intervention/treatment||Phase|
|Stroke||Device: stenting||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Recanalization and Stenting for Subacute and Chronic Veterbrobasilar Artery Occlusion|
|Actual Study Start Date :||April 2013|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||December 2015|
|Experimental: recanalization and stenting||
Apollo stent (MicroPort Medical, China),Neuroform stent (Stryker/Boston Scientific, USA) or Wingspan stent (Stryker/Boston Scientific, USA), et al.
- Change from Baseline in Modified Rankin Scale at Six Months postoperative [ Time Frame: six months to two years ]Modified Rankin Scale (mRS) was used to evaluate the level of disability
- Changes from Baseline in Modified Rankin Scale (mRS) at one year postoperative [ Time Frame: one to three years ]
- Number of Participants with Adverse Events [ Time Frame: up to three years ]
- hemorrhagic or ischemic
- ipsilateral or non-ipsilateral
- disability or non-disability
- the causes
- Changes from Baseline in NIHSS (National Institutes of Health Stroke Scale) at Six Months postoperative [ Time Frame: six months to two years ]NIHSS (National Institutes of Health Stroke Scale) is used to evaluate the severity of neurological deficit.
- Rate of Successful Recanalization [ Time Frame: two years ]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.
- Changes from Baseline in BI (Barthel Index) at Six Months postoperative [ Time Frame: six months to two years ]BI (Barthel Index) is used to evaluate activities of daily living.
- Changes from Baseline in WHOQOL-BREF (The World Health Organization Quality of Life - BREF)at Six Months postoperative [ Time Frame: six months to two years ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01632865
|Henan Provincial People'S Hospital|
|Zhengzhou, Henan, China, 450003|
|Henan provincial intervention therapy center|
|Zhengzhou, Henan, China|
|Study Chair:||Tianxiao Li, MD. PhD||Henan provincial intervention therapy center|
|Study Director:||Ziliang Wang, MD||Henan Provincial Hospital|
|Principal Investigator:||Yingkun He, MD.||Henan Provincial Hospital|