Angioplasty and Stenting for Patients With Symptomatic Intracranial Atherosclerosis

NCT ID: NCT02689037

Last Updated: 2016-04-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 394 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2019-12-31

Brief 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.

Conditions

Intracranial Atherosclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

stenting+medical treatment

Patients in PTAS+MT group will receive Percutaneous transluminal angioplasty and stenting and medical treatment (aspirin 100mg daily and clopidogrel 75mg daily)

Group Type: EXPERIMENTAL

Percutaneous transluminal angioplasty and stenting

Intervention Type: PROCEDURE

Surgeons will plant stents after vascular angioplasty in target ICAS vessels within 5 days after randomization.

Aspirin plus clopidogrel

Intervention Type: DRUG

aspirin 100mg daily and clopidogrel 75mg daily for 90 days

Aspirin plus clopidogrel

Patients in aspirin plus clopidogrel group will receive aspirin 100mg daily and clopidogrel 75mg daily for 90 days.

Group Type: ACTIVE_COMPARATOR

Aspirin plus clopidogrel

Intervention Type: DRUG

aspirin 100mg daily and clopidogrel 75mg daily for 90 days

Interventions

Percutaneous transluminal angioplasty and stenting

Surgeons will plant stents after vascular angioplasty in target ICAS vessels within 5 days after randomization.

Intervention Type: PROCEDURE

Aspirin plus clopidogrel

aspirin 100mg daily and clopidogrel 75mg daily for 90 days

Intervention Type: DRUG

Other Intervention Names

PTAS; Aspirin+clopidogrel

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The 476th Hospital of People's Liberation Army

OTHER

Sponsor Role: lead

Responsible Party

Feng-Feng Shen

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hang Lin, MD

Role: PRINCIPAL_INVESTIGATOR

Fuzhou General Hospital of Nanjing Command, People's Liberation Army and Clinical Medical College of Fujian Medical University

Central Contacts

Xiao-Ping Cui, MD

Role: CONTACT

xiaopingcuidr@126.com

0591-22859529

References

Cui XP, Lin M, Mu JS, Ye JX, He WQ, Fu ML, Li H, Fang JY, Shen FF, Lin H. Angioplasty and stenting for patients with symptomatic intracranial atherosclerosis: study protocol of a randomised controlled trial. BMJ Open. 2016 Nov 15;6(11):e012175. doi: 10.1136/bmjopen-2016-012175.

Reference Type: DERIVED

PMID: 27852711 (View on PubMed)

Other Identifiers

12MA100

Identifier Type: -

Identifier Source: org_study_id