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StrokeNCT01632865

Recanalization and Stenting for Non-acute Veterbrobasilar Artery Occlusion

A study testing stenting in people with Stroke, run by Zhengzhou University at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 30 years and older
Conditions the study is for
Stroke
What is being tested?
stenting
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
2 sitesChina
Study dates
Apr 2013to Dec 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 20Show fewer
  • 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.

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • Henan Provincial People'S Hospital

    Zhengzhou, Henan, 450003

  • Henan provincial intervention therapy center

    Zhengzhou, Henan

Other trials in China

About this study

Official title: Recanalization and Stenting for Subacute and Chronic 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.

Read the 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。

Conditions
Stroke
Being tested
stenting
Keywords
occlusion, recanalization, stenting
Medical subject headings
Stroke, Bites and Stings

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • stentingDevice

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

Study groups in NCT01632865
Study groupRoleWhat they receive
recanalization and stentingExperimentalNot described
Receives: Device: stenting

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Baseline in Modified Rankin Scale at Six Months postoperative

    Modified Rankin Scale (mRS) was used to evaluate the level of disability

    Measured: six months to two years

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

    Measured: one to three years

Secondary outcomes (5)

  1. Number of Participants with Adverse Events

    1. hemorrhagic or ischemic
    2. ipsilateral or non-ipsilateral
    3. disability or non-disability
    4. the causes
    5. others

    Measured: up to three years

  2. Changes from Baseline in NIHSS (National Institutes of Health Stroke Scale) at Six Months postoperative

    NIHSS (National Institutes of Health Stroke Scale) is used to evaluate the severity of neurological deficit.

    Measured: six months to two years

  3. Rate of Successful Recanalization

    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.

    Measured: two years

  4. Changes from Baseline in BI (Barthel Index) at Six Months postoperative

    BI (Barthel Index) is used to evaluate activities of daily living.

    Measured: six months to two years

  5. Changes from Baseline in WHOQOL-BREF (The World Health Organization Quality of Life - BREF)at Six Months postoperative

    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.

    Measured: six months to two years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jul 2012 (estimated)
  2. Study startApr 2013
  3. Primary completionDec 2015
  4. Study completionDec 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01632865
Sponsor's protocol ID
415807818
Status last verified
Jan 2017
First submitted
8 Jun 2012
Last updated
25 Jan 2017
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing stenting in people with Stroke, run by Zhengzhou University at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline in Modified Rankin Scale at Six Months postoperative (time frame: six months to two years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01632865.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2017; AzTrials last refreshed its copy on 7 Nov 2026.

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