Recanalization and Stenting for Non-acute Intracranial Artery Occlusion
To evaluate whether recanalization and stenting for symptomatic subacute and chronic intracranial artery occlusion is technically feasible, can prevent from recurrent ischemic events and promotes functional recovery of disability.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Recanalization and Stenting for Subacute and Chronic Intracranial Artery Occlusion|
- Change from Baseline in Modified Rankin Scale at Six Months postoperative [ Time Frame: six months to two years ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]
- Number of Participants with Adverse Events [ Time Frame: up to three years ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]NIHSS (National Institutes of Health Stroke Scale) is used to evaluate the severity of neurological deficit.
- Rate of Successful Recanalization [ Time Frame: two years ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]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.
|Study Start Date:||February 2010|
|Estimated Study Completion Date:||June 2014|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
|Experimental: recanalization and stenting||
Apollo stent (MicroPort Medical, China),Neuroform stent (Stryker/Boston Scientific, USA) or Wingspan stent (Stryker/Boston Scientific, USA), et al.
Ischemic stroke accounts for 87% of cerebrovascular accidents. Of these, a part is the result of intracranial artery occlusion. Acute intracranial artery occlusion is a devastating disease with high mortality without successful treatment. A subset of patients with intracranial artery occlusion can survive the acute phase and develop subacute or chronic intracranial 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 intracranial 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 intracranial subacute-chronic intracranial artery occlusion。
Please refer to this study by its ClinicalTrials.gov identifier: NCT01632865
|Henan Provincial People'S Hospital||Recruiting|
|Zhengzhou, Henan, China, 450003|
|Contact: Zhigang Zhao firstname.lastname@example.org|
|Principal Investigator: Ziliang Wang|
|Sub-Investigator: Yingkun He, Doctor|
|Henan provincial intervention therapy center||Recruiting|
|Zhengzhou, Henan, China|
|Contact: Tianxiao Li email@example.com|
|Principal Investigator: Tianxiao Li|
|Sub-Investigator: Jiangyu Xue|
|Sub-Investigator: Liangfu Zhu|
|Sub-Investigator: Weixing Bai|
|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|