Angioplasty and Stenting for Patients With Symptomatic Intracranial Atherosclerosis

NCT02689037 | Unknown Phase 3 DMC

• 1 other identifier: 12MA100
• Study Type: interventional
• Target: 394
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with events of stroke or death

  at 30 days after randomization

Secondary Outcomes (3)

• 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

Study Arms (2)

stenting+medical treatment

EXPERIMENTAL

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; Drug: Aspirin plus clopidogrel

Aspirin plus clopidogrel

ACTIVE COMPARATOR

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

Drug: Aspirin plus clopidogrel

Interventions

Percutaneous transluminal angioplasty and stenting PROCEDURE

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

Also known as: PTAS

stenting+medical treatment

Aspirin plus clopidogrel DRUG

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

Also known as: Aspirin+clopidogrel

Aspirin plus clopidogrel; stenting+medical treatment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The 476th Hospital of People's Liberation Army: lead

Related Publications (1)

• 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.

  PMID: 27852711 DERIVED

MeSH Terms

Conditions

Intracranial Arteriosclerosis

Interventions

Angioplasty; Stents; Aspirin; Clopidogrel

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques; Prostheses and Implants; Equipment and Supplies; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Hang Lin, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiao-Ping Cui, MD

CONTACT

0591-22859529; xiaopingcuidr@126.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: February 17, 2016
• First Posted: February 23, 2016
• Study Start: April 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2019
• Last Updated: April 5, 2016

Record last verified: 2016-04