Enterprise Stent Implantation in the Treatment of Carotid Artery Stenosis With Ischemic Stroke
Condition: Carotid Artery Stenosis
MeSH terms: Ischemic Stroke; Carotid Stenosis; Constriction, Pathologic
Study type: Interventional

Summary: 
      To investigate the long-term effects of intracranial implantation of Enterprise stent system
      versus antiplatelet medication on neurologic deficits, daily living abilities, and carotid
      artery stenosis in patients with atherosclerotic ischemic stroke.
    

Detailed description: 
      Atherosclerosis is a chronic degenerative disease that can cause intracranial carotid artery
      stenosis, which is a leading cause of ischemic stroke. The currently used interventions for
      carotid artery stenosis in ischemic stroke include internal medication, carotid
      endarterectomy (CEA) and carotid angioplasty and stenting (CAS). Internal medication for
      carotid artery stenosis is mainly performed to reduce risk factors for cerebrovascular
      disease, including anti-platelet aggregation, anticoagulation, lowering blood lipid and blood
      pressure, controlling blood glucose and improving living habits. As for patients with mild
      carotid artery stenosis, internal medication is generally recommended. Carotid endarterectomy
      has been confirmed to be a gold standard for the treatment of carotid artery stenosis.
      However, it is also limited by some factors including sophisticated technique, great trauma,
      general anesthesia, severe stroke, 9% fatality rate, and 7.6% cranial nerve injury. In
      addition, carotid endarterectomy is not suitable for patients with high-position or tandem
      carotid artery stenosis or carotid artery stenosis complicated by contralateral carotid
      artery occlusion. In recent years, CAS has been increasingly used for the treatment of
      carotid artery stenosis in patients with ischemic stroke because of its minimally invasive
      procedure, rapid recovery process and wide indications.

      Enterprise stent system is a U.S. Food and Drug Administration (FDA)-approved closed loop
      recoverable self-expanding stent that has been confirmed to be highly effective in the
      treatment of intracranial aneurysm. Existing evidence on use of Enterprise stent system for
      intracranial artery stenosis in patients with ischemic stroke mainly focus on case series and
      case reports.

      There is a lack of randomized controlled trial evidence regarding long-term effects of
      Enterprise stent implantation for the treatment of carotid artery stenosis after ischemic
      stroke. The existing related reports are case series or case reports with the caveats like
      non-randomized, non-blinded design with small sample sizes. Therefore, in this study, the
      investigators designed a double-blind, randomized, drug control trial to investigate the
      efficacy of Enterprise stent implantation in the treatment of carotid artery stenosis in
      patients with ischemic stroke.

      Enterprise stent system is a novel closed loop self-expanding stent that is made of Ni-Ti
      alloy and shows favorable flexibility and ease in use, and its use was approved in 2009 in
      China. The current clinical evidence regarding use of Enterprise stent system mainly address
      on aneurismal treatment. In this study, the investigators will use Enterprise stent system to
      treat carotid artery stenosis in patients with ischemic stroke, which is of important
      clinical significance for secondary prevention of ischemic stroke. In addition, there is no
      long-term follow-up evidence regarding Enterprise stent implantation of carotid artery
      stenosis after ischemic stroke, so 3-year follow-up will be performed in this study.

      In this study, simple antiplatelet drug will be used as controls to investigate the
      superiority of Enterprise stent implantation in combination with antiplatelet over
      antiplatelet medication only in the treatment of carotid artery stenosis. Outcomes from this
      study will add objective, rigorous, double-blind, randomized, controlled long-term follow-up
      trial evidence to Enterprise stent implantation for the treatment of carotid artery stenosis
      after ischemic stroke.

      Adverse events Possible adverse events associated with Enterprise stent implantation include
      puncture site hematoma, vascular spasm, bradycardia, hypotension, cerebral hyperperfusion
      syndrome, device shifting, local ischemia, vascular occlusion, ischemic stroke,
      intraoperative hypertension, postoperative hypotension and hypoglycemia. If adverse events
      occur, details of the event including the date of occurrence, measures taken related to the
      treatment, causal relationship with the treatment and treatment of the adverse event will be
      reported to the principal investigator and the institutional review board within 24 hours.

      Data collection, management, analysis and open access All data will be collected in case
      report forms and collated. Collated data will be input into an electronic database using a
      double-data entry strategy by trained professional stall. Information accuracy will be
      checked when all included patients will be followed up. The collected data will be locked by
      a researcher in charge and will not be altered for later review. All data related to this
      trial will be preserved by Beijing Chao-yang Hospital, Capital Medical University, China. The
      electronic database will be fully known to a professional statistician for statistical
      analysis. Anonymized trial data will be published at http://www.figshare.com.

      Statistical analysis All data will be statistically analyzed by a statistician blinded to
      randomization using SPSS 17.0 software. The successive normally distributed variables will be
      expressed as the mean ± SD. The non-normally distributed variables will be expressed as
      median and quartile. Classification variables will be expressed as counts and the percentage.
      Two-sample t-test (normally distributed data) or Mann-Whitney U test (non-normally
      distributed data) will be used for comparison of NIHSS score and Barthel index between stent
      implantation and drug groups. Chi-square test or Fisher's exact test will be used for
      comparison of carotid stenosis rate between these two groups. A level of P < 0.05 will be
      accepted as statistically significant.

      Auditing Trial progression will be reported to the ethics committee of Beijing Chao-yang
      Hospital, Capital Medical University, China every 1 year and the trial's status will be
      updated in the registration database.

      Confidentiality Trial data include paper and electronic forms. Electronic data will be
      preserved in a dedicated password-protected computer and managed by a data management
      professional. Data reported on paper will be preserved in a secure, locked place for future
      viewing.
    

Intervention name(s): Enterprise stent implantation; Only aspirin medication
Intervention type(s): Device; Drug
Intervention description(s): Enterprise stent system (Johnson & Johnson (Shanghai) Medical Equipment Co.,Ltd., China) is a closed loop self-expanding stent system that is made of Ni-Ti alloy. It consists of a self-expanding stent and a delivery system.; Only aspirin medication will be conducted, initial dose is 300 mg/d, 200 mg/d 6 months later, and 100 mg/d 1 year later.
Other intervention name(s): Enterprise self-expanding stent system implantation; Drug intervention
Intervention MeSH terms: Aspirin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment