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Recanalization and Stenting for Non-acute Veterbrobasilar Artery Occlusion

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ClinicalTrials.gov Identifier: NCT01632865
Recruitment Status : Completed
First Posted : July 3, 2012
Last Update Posted : January 25, 2017
Sponsor:
Collaborators:
Henan provincial interventional therapy center
Henan Provincial Hospital
Information provided by (Responsible Party):
Yingkun He, Henan Provincial Hospital

Tracking Information
First Submitted Date  ICMJE June 8, 2012
First Posted Date  ICMJE July 3, 2012
Last Update Posted Date January 25, 2017
Actual Study Start Date  ICMJE April 2013
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 3, 2012)
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 28, 2012)
Change from Baseline in Modified Rankin Scale at Six Months postoperative [ Time Frame: two years ]
Modified Rankin Scale (mRS) was used to evaluate the level of disability
Change History Complete list of historical versions of study NCT01632865 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 3, 2012)
  • Number of Participants with Adverse Events [ Time Frame: up to three years ]
    1. hemorrhagic or ischemic
    2. ipsilateral or non-ipsilateral
    3. disability or non-disability
    4. the causes
    5. others
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 28, 2012)
  • Number of Participants with Adverse Events [ Time Frame: two to three years ]
    1. hemorrhagic or ischemic
    2. ipsilateral or non-ipsilateral
    3. disability or non-disability
    4. the causes
    5. others
  • Changes from Baseline in NIHSS, BI and WHOQOL-BREF at Six Months postoperative [ Time Frame: two years ]
    1. NIHSS (National Institutes of Health Stroke Scale) is used to evaluate the severity of neurological deficit.
    2. BI (Barthel Index) is used to evaluate activities of daily living.
    3. 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.
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Recanalization and Stenting for Non-acute Veterbrobasilar Artery Occlusion
Official Title  ICMJE Recanalization and Stenting for Subacute and Chronic Veterbrobasilar Artery Occlusion
Brief Summary 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.
Detailed Description 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。
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Stroke
Intervention  ICMJE Device: stenting
Apollo stent (MicroPort Medical, China),Neuroform stent (Stryker/Boston Scientific, USA) or Wingspan stent (Stryker/Boston Scientific, USA), et al.
Study Arms  ICMJE Experimental: recanalization and stenting
Intervention: Device: stenting
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 28, 2012)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Stroke or TIA (transient ischemic attack) due to the intracranial veterbrobasilar artery occlusion.
  2. Occlusions may be diagnosed by TCD (transcranial cerebral doppler), MRA (magnetic resonance angiography), or CTA (computed tomographic angiography) to qualify for angiogram performed as part of the study protocol but must be confirmed by catheter angiography for enrollment in the trial
  3. Time from imaging-documented occlusion and/or from aggravation of clinical symptoms (aggravation was defined as change in mRS [modified rankin scale]≥1 and/or NIHSS [national institutes of health stroke scale]≥4) to recanalization was greater than 24 hours. The reasons for delayed intervention were due to delayed diagnosis, interhospital transfer, or unsuccessful initial trial of anticoagulation and antiplatelet therapy.
  4. Etiology was suitable for stenting, which was judged by at least a neurologist, a neurosurgeon and a neuro-interventionalist.

Exclusion Criteria:

  1. Unsuitable etiology.
  2. Stenting, angioplasty, or endarterectomy of an extracranial (carotid or vertebral artery) or intracranial artery within 30 days prior to expected enrollment date
  3. Any aneurysm without treatment proximal to or distal to occluded intracranial artery
  4. Intracranial tumor (except meningioma) or any intracranial vascular malformation
  5. CT or angiographic evidence of severe calcification at target lesion
  6. Brain infarct within previous 30 days of enrollment that is of sufficient size (> 5 cms) to be at risk of hemorrhagic conversion during or after stenting
  7. Any hemorrhagic infarct within 14 days prior to enrollment
  8. Any hemorrhagic infarct within 15 - 30 days that is associated with mass effect
  9. Any history of a primary intracerebral (parenchymal) hemorrhage (ICH)
  10. Any other intracranial hemorrhage (subarachnoid, subdural, epidural) within 30 days
  11. Any untreated chronic subdural hematoma of greater than 5 mm in thickness
  12. Presence of any of the following unequivocal cardiac sources of embolism: chronic or paroxysmal atrial fibrillation, mitral stenosis, mechanical valve, endocarditis, intracardiac clot or vegetation, myocardial infarction within three months, dilated cardiomyopathy, left atrial spontaneous echo contrast, ejection fraction less than 30%
  13. Known allergy or contraindication to aspirin, clopidogrel, heparin, metal, local or general anesthesia
  14. History of life-threatening allergy to contrast dye.
  15. Active peptic ulcer disease, major systemic hemorrhage within 30 days, active bleeding diathesis, platelets < 100,000, hematocrit < 30, INR [international normalized ratio] > 1.5, clotting factor abnormality that increases the risk of bleeding, current alcohol or substance abuse, uncontrolled severe hypertension (systolic pressure > 180 mm Hg or diastolic pressure > 115 mm Hg), severe liver impairment (AST [aspartate transaminate]or ALT [alanine transaminase]> 3 x normal, cirrhosis), creatinine > 3.0 (unless on dialysis)
  16. Major surgery (including open femoral, aortic, or carotid surgery) within previous 30 days or planned in the next 90 days after enrollment
  17. Pregnancy or of childbearing potential and unwilling to use contraception for the duration of this study
  18. Life expectancy<1 year due to other medical conditions.
  19. Enrollment in another study that would conflict with the current study
  20. Other special conditions considered by neurological physician, neurosurgeon and neuro-intervention doctors, weren't suitable for recanalization procedure.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01632865
Other Study ID Numbers  ICMJE 415807818
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yingkun He, Henan Provincial Hospital
Study Sponsor  ICMJE Zhengzhou University
Collaborators  ICMJE
  • Henan provincial interventional therapy center
  • Henan Provincial Hospital
Investigators  ICMJE
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
PRS Account Zhengzhou University
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP