Recanalization and Stenting for Non-acute Intracranial Artery Occlusion

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Zhengzhou University
Sponsor:
Collaborators:
Henan provincial interventional therapy center
Henan Provincial Hospital
Information provided by (Responsible Party):
Yingkun He, Henan Provincial Hospital
ClinicalTrials.gov Identifier:
NCT01632865
First received: June 8, 2012
Last updated: May 16, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention
Stroke
Device: stenting

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Zhengzhou University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Number of Participants with Adverse Events [ Time Frame: up to three years ] [ Designated as safety issue: Yes ]
    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 ] [ 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.


Estimated Enrollment: 60
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)
Arms Assigned Interventions
Experimental: recanalization and stenting Device: stenting
Apollo stent (MicroPort Medical, China),Neuroform stent (Stryker/Boston Scientific, USA) or Wingspan stent (Stryker/Boston Scientific, USA), et al.

Detailed Description:

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。

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Stroke or TIA (transient ischemic attack) due to the intracranial 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01632865

Locations
China, Henan
Henan Provincial People'S Hospital Recruiting
Zhengzhou, Henan, China, 450003
Contact: Zhigang Zhao       sykywsc@163.com   
Contact       hnpivr@yeah.com   
Principal Investigator: Ziliang Wang         
Sub-Investigator: Yingkun He, Doctor         
Henan provincial intervention therapy center Recruiting
Zhengzhou, Henan, China
Contact: Tianxiao Li       dr.litianxiao@vip.163.com   
Contact       hnpivr@yeah.com   
Principal Investigator: Tianxiao Li         
Sub-Investigator: Jiangyu Xue         
Sub-Investigator: Liangfu Zhu         
Sub-Investigator: Weixing Bai         
Sponsors and Collaborators
Zhengzhou University
Henan provincial interventional therapy center
Henan Provincial Hospital
Investigators
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
  More Information

No publications provided

Responsible Party: Yingkun He, Study Principal Investigator, Henan Provincial Hospital
ClinicalTrials.gov Identifier: NCT01632865     History of Changes
Other Study ID Numbers: 415807818
Study First Received: June 8, 2012
Last Updated: May 16, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Zhengzhou University:
occlusion
recanalization
stenting

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 21, 2014