Recanalization and Stenting for Non-acute Veterbrobasilar Artery Occlusion

NCT01632865 | Completed DMC

• 1 other identifier: 415807818
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Stroke

Keywords

occlusion; recanalization; stenting

Outcome Measures

Primary Outcomes (2)

• Change from Baseline in Modified Rankin Scale at Six Months postoperative

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

  six months to two years

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

  one to three years

Secondary Outcomes (5)

• Number of Participants with Adverse Events

  up to three years

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

  six months to two years

• Rate of Successful Recanalization

  two years

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

  six months to two years

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

  six months to two years

Study Arms (1)

recanalization and stenting

EXPERIMENTAL

Device: stenting

Interventions

stenting DEVICE

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

recanalization and stenting

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Zhengzhou University: lead
• Henan provincial interventional therapy center: collaborator
• Henan Provincial People's Hospital: collaborator

Study Sites (2)

Henan Provincial People'S Hospital

Zhengzhou, Henan, 450003, China

Location

Henan provincial intervention therapy center

Zhengzhou, Henan, China

Location

MeSH Terms

Conditions

Stroke; Bites and Stings

Interventions

Stents

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies

Study Officials

• Tianxiao Li, MD. PhD

  Henan provincial intervention therapy center

  STUDY CHAIR

• Ziliang Wang, MD

  Henan Provincial People's Hospital

  STUDY DIRECTOR

• Yingkun He, MD.

  Henan Provincial People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Principal Investigator

Study Record Dates

• First Submitted: June 8, 2012
• First Posted: July 3, 2012
• Study Start: April 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: January 25, 2017

Record last verified: 2017-01

Locations

CN (2)