Recanalization and Stenting for Subacute and Chronic Veterbrobasilar Artery Occlusion
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Stroke
- Sponsor
- Zhengzhou University
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- Change from Baseline in Modified Rankin Scale at Six Months postoperative
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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。
Investigators
Yingkun He
Study Principal Investigator
Henan Provincial People's Hospital
Eligibility Criteria
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
Outcomes
Primary Outcomes
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
Secondary Outcomes
- 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)