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Completed

NCT Number: NCT01632865

Recanalization and Stenting for Non-acute Veterbrobasilar Artery Occlusion

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.

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Key information

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Henan Provincial People'S Hospital, Zhengzhou, Henan, China

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About this study

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。

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Stroke or TIA (transient ischemic attack) due to the intracranial veterbrobasilar artery occlusion.
  • 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
  • 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.
  • Etiology was suitable for stenting, which was judged by at least a neurologist, a neurosurgeon and a neuro-interventionalist.

Exclusion criteria

  • Unsuitable etiology.
  • Stenting, angioplasty, or endarterectomy of an extracranial (carotid or vertebral artery) or intracranial artery within 30 days prior to expected enrollment date
  • Any aneurysm without treatment proximal to or distal to occluded intracranial artery
  • Intracranial tumor (except meningioma) or any intracranial vascular malformation
  • CT or angiographic evidence of severe calcification at target lesion
  • 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
  • Any hemorrhagic infarct within 14 days prior to enrollment
  • Any hemorrhagic infarct within 15 - 30 days that is associated with mass effect
  • Any history of a primary intracerebral (parenchymal) hemorrhage (ICH)
  • Any other intracranial hemorrhage (subarachnoid, subdural, epidural) within 30 days
  • Any untreated chronic subdural hematoma of greater than 5 mm in thickness
  • 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%
  • Known allergy or contraindication to aspirin, clopidogrel, heparin, metal, local or general anesthesia
  • History of life-threatening allergy to contrast dye.
  • 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)
  • Major surgery (including open femoral, aortic, or carotid surgery) within previous 30 days or planned in the next 90 days after enrollment
  • Pregnancy or of childbearing potential and unwilling to use contraception for the duration of this study
  • Life expectancy<1 year due to other medical conditions.
  • Enrollment in another study that would conflict with the current study
  • Other special conditions considered by neurological physician, neurosurgeon and neuro-intervention doctors, weren't suitable for recanalization procedure.

Treatment and study plan

Stenting

Device

Apollo stent (MicroPort Medical, China),Neuroform stent (Stryker/Boston Scientific, USA) or Wingspan stent (Stryker/Boston Scientific, USA), et al.

Primary outcomes

  1. 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

  2. Changes from Baseline in Modified Rankin Scale (mRS) at one year postoperative

    Time frame: one to three years

Secondary outcomes

  1. 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
    • others
  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Zhengzhou University

Other

Collaborators

  • Henan Provincial People's Hospital
  • Henan provincial interventional therapy center

Registry information

Official study title

Recanalization and Stenting for Subacute and Chronic Veterbrobasilar Artery Occlusion

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jul 3, 2012
Registry last updated
Jan 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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