Stenting for Symptomatic Intracranial Artery Stenosis Registry in China

Capital Medical University

Status: Unknown

Conditions: Systematic Intracranial Artery Stenosis

Study type: Observational

Funder types: Other

Identifiers

NCT01830413

stent-2013

Details and patient eligibility

About

Stenting for systematic Intracranial artery stenosis is challenged recently, especially for safety. This registry is aimed to explore the safety profile during peri-operation period in Stenting procedures for systematic Intracranial artery stenosis in Chinese population in real world.

Enrollment: 450 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18-80 year old
• medical failure patient with systematic Intracranial artery stenosis
• More than 3 weeks after most recent ischemic stroke
• Digital Subtraction Angiography(DSA) showed ≥70% stenosis in target intracranial artery
• Imaging test within 1 week showed bad collateral circulation in target vessel area
• Diseased vessel diameter≥2mm, length <15mm, distal vessel is normal

Exclusion criteria

• Diffused intracranial stenosis

• Acute stroke or TIA within 3 weeks

• Pure penetrating branch stenosis showed by cerebral imaging

• Non-atherosclerosis pathology for the stenosis

• Intracranial hemorrhage in target vessel area within 6 weeks; or potential cardiac thrombus source

• Intracranial tumor, arterial aneurysm or intracranial arteriovenous malformation

  •>50% stenosis in extracranial carotid artery or vertebral artery in operation side; Known contradiction to heparin, aspirin, clopidogrel, anesthesia or contrast; hemoglobin <10g/dl，platelet count <100000

• Modified Rankin score ≥3 related to target vessel;

• INR(International Normalized Ratio)>1.5(irreversible），persist hemorrhage risk; life expectancy < 1year

• Pregnant or beast-feeding

• Not suitable for endovascular stenting judged by Indication Judgement Committee

Trial design

450 participants in 1 patient group

Stenting

Description:

cerebral artery stenting for systematic Intracranial artery stenosis