Angioplasty and Stenting for Patients With Symptomatic Intracranial Atherosclerosis

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

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.

Study Overview

• Status: Unknown
• Conditions: Intracranial Atherosclerosis
• Intervention / Treatment: Procedure: Percutaneous transluminal angioplasty and stenting; Drug: Aspirin plus clopidogrel

• Study Type: Interventional
• Enrollment (Anticipated): 394
• Phase: Phase 3

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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)	Procedure: Percutaneous transluminal angioplasty and stenting; Surgeons will plant stents after vascular angioplasty in target ICAS vessels within 5 days after randomization.; Other Names: PTAS; Drug: Aspirin plus clopidogrel; aspirin 100mg daily and clopidogrel 75mg daily for 90 days; Other Names: Aspirin+clopidogrel
Active Comparator: Aspirin plus clopidogrel; Patients in aspirin plus clopidogrel group will receive aspirin 100mg daily and clopidogrel 75mg daily for 90 days.	Drug: Aspirin plus clopidogrel; aspirin 100mg daily and clopidogrel 75mg daily for 90 days; Other Names: Aspirin+clopidogrel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of patients with events of stroke or death	at 30 days after randomization

Secondary Outcome Measures

Outcome Measure	Time Frame
the incidence of recurrent ischaemic stroke in the stenting-involved vascular territory	30 days and 1 year after randomization
neurological functional outcome by the Chinese version of National Institutes of Health Stroke Scale (C-NIHSS)	30 days and 1 year after randomization
Proportion of patients with adverse events	30 days and 1 year after randomization

Collaborators and Investigators

• Sponsor: The 476th Hospital of People's Liberation Army
• Investigators: Principal Investigator: Hang Lin, MD, Fuzhou General Hospital of Nanjing Command, People's Liberation Army and Clinical Medical College of Fujian Medical University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: February 17, 2016
• First Submitted That Met QC Criteria: February 18, 2016
• First Posted (Estimate): February 23, 2016

Study Record Updates

• Last Update Posted (Estimate): April 5, 2016
• Last Update Submitted That Met QC Criteria: April 4, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Intracranial Arterial Diseases; Atherosclerosis; Intracranial Arteriosclerosis; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Aspirin; Clopidogrel
• Other Study ID Numbers: 12MA100

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED