Angioplasty and Stenting for Patients With Symptomatic Intracranial Atherosclerosis

Intracranial Atherosclerosis Clinical Trial

Official title:

Angioplasty and Stenting for Patients With Symptomatic Intracranial Atherosclerosis: Study Protocol of a Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02689037
• Other study ID #: 12MA100
• Status: Not yet recruiting
• Phase: Phase 3
• First received: February 17, 2016
• Last updated: April 4, 2016
• Start date: April 2016
• Est. completion date: December 2019

Study information

• Verified date: April 2016
• Source: The 476th Hospital of People's Liberation Army
• Contact: Xiao-Ping Cui, MD
• Phone: 0591-22859529
• Email: xiaopingcuidr[@]126.com
• Is FDA regulated: No
• Health authority: China: Health and Family Planning Commission of Fujian Province
• Study type: Interventional

Clinical Trial Summary

Background: Effectiveness of Percutaneous transluminal angioplasty and stenting (PTAS) on prevention of events of stroke and death in patients with symptomatic intracranial atherosclerosis (ICAS) is controversial.

Aim: to determine whether PTAS plus medical treatment (MT) are superior to MT alone in preventing events of stroke and death in patients with symptomatic ICAS.

Methods: The investigators will carry out a randomized controlled trial in 3 hospitals in China. A total of 198 patients with ICAS will be randomized into 2 groups: PTAS+MT and MT group. All patients will receive aspirin (100 mg daily) and clopidogrel (75 mg daily) immediately after randomization, and patients in PTAS+MT group will receive surgery within 5 days after randomization. The patients will be followed up for 1 year after randomization and assessed for events of stroke and death at 30 days and 1 year after randomization, the incidence of recurrent ischaemic stroke in the stenting-involved vascular territory at 30 days and 1 year after randomization, incidence of in-stent restenosis at 1 year after randomization,etc.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 394
• Est. completion date: December 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Patients aged from 18 to 70 years.

• Complaints of a Symptomatic ICAS: a history of recurrent transient ischemic attacks or an ischemic stroke within 1 year owing to a 70%-99% stenosis in an internal carotid artery, middle cerebral artery, vertebral artery, or basilar artery.

• A length = 15mm of a stenosis in the target vessel and a vessel size >2.5mm.

• Hypoperfusion in the territory of the target vessels, which is determined by CT or MRI in 14 days before stenting.

• CT or MRI scans show no massive cerebral infarction (beyond half of the territory of middle cerebral artery (MCA)), intracranial hemorrhage, epidural or sub-dural hemorrhage, and intracranial brain tumor.

• Patients who understand the purpose of the study and have provided informed consent.

Exclusion Criteria:

• Not able to receive general anesthesia.

• Not able to receive angiographic assessment.

• A stenosis >50% in an extracranial carotid or vertebral artery on the ipsilateral side.

• Infarctions due to the perforators occlusion (determined by MRI scan), which is defined as basal ganglia or brainstem/thalamus infarction related with middle cerebral artery or basilar artery stenosis.

• A high risk (leading to a stroke or death) to deliver the stent to the lesion.

• A previous stent or angioplasty in the target lesion.

• Progressive neurological signs within 24 hours before enrolment

• Any haemorrhagic infarct within 14 days before enrolment

• The presence of a cardiac source of embolus

• Thrombolytic therapy within 24 hours before enrollment

• Presence of intraluminal thrombus proximal to or at the target lesion

• Myocardial infarction within previous 30 days

• Non-atherosclerotic lesions: arterial dissection, moya-moya disease; vasculitic disease; herpes zoster, varicella zoster or other viral vasculopathy; neurosyphilis; any other intracranial infection; any intracranial stenosis associated with cerebrospinal fluid pleocytosis; radiation-induced vasculopathy; fibromuscular dysplasia; sickle cell disease; neurofibromatosis; benign angiopathy of central nervous system; postpartum angiopathy; suspected vasospastic process, and suspected recanalized embolus.

• Known contraindications for aspirin and clopidogrel treatment.

• An modified Rankin scale=3.

• With a childbearing potential or a positive pregnancy test in 1 week before enrolment.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atherosclerosis
• Intracranial Arteriosclerosis
• Intracranial Atherosclerosis

Intervention

Procedure:
• Percutaneous transluminal angioplasty and stenting
Surgeons will plant stents after vascular angioplasty in target ICAS vessels within 5 days after randomization.

Drug:
• Aspirin plus clopidogrel
aspirin 100mg daily and clopidogrel 75mg daily for 90 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The 476th Hospital of People's Liberation Army

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with events of stroke or death		at 30 days after randomization	No
Secondary	the incidence of recurrent ischaemic stroke in the stenting-involved vascular territory		30 days and 1 year after randomization	No
Secondary	neurological functional outcome by the Chinese version of National Institutes of Health Stroke Scale (C-NIHSS)		30 days and 1 year after randomization	No
Secondary	Proportion of patients with adverse events		30 days and 1 year after randomization	Yes