Clinical trial NCT00685308: Wingspan Stenting for Symptomatic Severe Stenosis of Intracranial Atherosclerosis Registry in China
Official title: Wingspan Stenting for Symptomatic Severe Stenosis of Intracranial Atherosclerosis Registry in China
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Intracranial Atherosclerosis
Keywords: Atherosclerosis
Intracranial artery
Angioplasty
Stent
Lead sponsor: Ministry of Health, China
Sponsor class: OTHER_GOV
First posted: 2008-05-28
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chinese population with symptomatic severe stenosis of intracranial atherosclerosis

Brief summary: This is a prospective, multi-center, non-randomized trial to study one-year outcomes of the Wingspan system for the treatment of Chinese patients with symptomatic atherosclerotic severe intracranial stenosis.

Detailed description: The study will enroll 200 Chinese patients with atherosclerotic intracranial stenosis of 70% to 99% that causes a recent ischemic neurologic event.

The Winspan stenting following undersized Gateway balloon angioplasty will be performed at experienced centers (at least 10 cases' experiences of using the Wingspan system to treat the patients with intracranial stenosis for each center).

The primary endpoint of the study, independently evaluated by neurologists, is any stroke or death within 30 days, plus ischemic stroke in the stented artery territory between 31 day and 1 year.

Eligibility criteria: Inclusion Criteria:

* An angiographically verified ≥ 70% stenosis of a major intracranial artery that causes TIA or minor stroke (NIH Stroke Scale score \<9) within 90 days;
* the lesion length \<15 mm and normal arterial diameter adjacent to it between 2.0 mm and 4.5 mm;
* patients having at least one atherosclerotic risk factor (arterial hypertension, diabetes mellitus, hyperlipidemia, hyperhomocysteinemia and cigarette smoking).

Exclusion Criteria:

* Non-atherosclerotic stenosis;
* intracranial hemorrhage in the territory of the stenotic artery within 6 weeks; potential source of cardiac embolism;
* concurrent intracranial tumor, aneurysm and cerebral arteriovenous malformation;
* tandem \>50% stenosis of extracranial carotid or vertebral artery; known contraindication to heparin, aspirin, clopidogrel, anesthesia and contrast media; hemoglobin \<10 g/dl, platelet count \<100,000;
* international normalized ratio \>1.5 (irreversible) and uncorrectable bleeding diathesis; and life expectancy \<1 years because of other medical conditions.

Primary outcomes:
measure: Any stroke or death within 30 days, plus ischemic stroke in the stented artery territory between 31 day and 1 year
timeFrame: One year
Secondary outcomes:
measure: Ischemic stroke in the non-stented artery territory, hemorrhagic stroke and death from other vascular causes beyond 30 days, and emergent cerebral revascularization (ECER)and other major hemorrhages at any time within 1 year, and restenosis.
timeFrame: One year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijiang Tiantan Hospital, The Capital Medical University
Study officials:
affiliation: Beijing Tiantan Hospital, The Capital Medical University, Beijing, China
name: Wei-Jian Jiang, MD
role: PRINCIPAL_INVESTIGATOR
References: