Standardized Procedure for Intracranial Drug-Eluting Stenting in the Treatment of Intracranial Atherosclerotic Stenosis

Sino Medical Sciences Technology Inc.300 enrolled

Overview

The primary objective of this trial is to evaluate the Safety, Efficacy, and Standardized Procedural Optimization of the Intracranial Drug-Eluting Stent System in Patients with Symptomatic Intracranial Atherosclerotic Stenosis.

The investigation is a prospective, multi-center clinical study. The trial is expected to enroll 300 subjects. The population for this study is subjects with intracranial atherosclerotic stenosis who are suitable candidates for stent angioplasty. Patients fulfilling all of the inclusion criteria and none of the exclusion criteria will be enrolled after they signed the informed consent form. The study consists of ten visits including preoperative screening, procedure date, 30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years. The primary endpoints are stroke or death within 30 days after enrollment, plus any ischemic stroke or revascularization from the original culprit intracranial artery beyond 30 days through 12 months after procedure.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

300

Conditions

Intracranial Atherosclerotic Stenosis

Interventions

NOVA DESDEVICE

The NOVA stent is a sirolimus-eluting stent system designed for intracranial artery stenosis with a rapid exchangeable balloon

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Males or females between 18 and 80 years of age 2. Symptomatic intracranial arteriosclerosis stenosis with reference diameter 2.25-4.00mm 3. Intracranial artery stenosis ( ≥70%) conformed by DSA 4. Those who voluntarily participate in the study and sign informed consent form Exclusion Criteria: 1. Those who have surgery within previous 30 days or plan to perform major surgery in the next 90 days (surgery grade 3 and above); 2. Subjects of acute hemorrhagic stroke within 3 months; 3. The baseline mRS of disabling stroke is more than 3; 4. The target vessel is severely calcified and closely related to stenosis; 5. Non-atherosclerotic diseases (e.g. arterial dissection, Moya Moya disease, vascular inflammatory lesions caused by infection, autoimmune diseases, post-irradiation, postpartum status; developmental or genetic abnormalities such as fibromuscular dysplasia, sickle cell anemia, suspected vasospasm); 6. It is suspected that the ischemic event is due to embolism or arterial embolism from the extracranial segment (including ipsilateral chest or neck vascular occlusive disease) or potential cardiogenic embolism (e.g. atrial fibrillation, mitral stenosis, patent foramen ovale, left ventricular thrombus, myocardial infarction within 6 weeks, etc.); 7. The presence of a \>50% stenosis in the main blood supply artery of the target vessel. For example, when the lesion is located in the middle cerebral artery, the ipsilateral internal carotid artery stenosis by over 50% should be excluded; when the lesion is located in the basilar artery, the dominant side vertebral artery stenosis \>50% should be excluded; 8. There are intracranial tumors, or intracranial arteriovenous malformations; 9. Those who are allergic to heparin, aspirin, clopidogrel, contrast agents, anesthetics, and stent components; 10. Pregnant and lactating women 11. Those who are unable to complete follow-up because of mental illness, cognitive or emotional disorders; 12. Inapplicable for this study at the investigators' viewpoints.

Locations (1)

The first affiliated hospital of zhengzhou university

Zhengzhou, China

RECRUITING

Outcomes

Primary Outcomes

Stroke or death within 30 days after enrollment, plus any ischemic stroke or revascularization from the original culprit intracranial artery beyond 30 days through 12 months after procedure.

This outcome includes ischemic/hemorrhagic stroke and all-cause death within 30 days after procedure of the qualifying lesion during follow-up, or any ischemic stroke and revascularization from the original culprit symptomatic intracranial artery beyond 30 days through 12 months after procedure.

Time frame: 1 year after procedure

Secondary Outcomes

Rate of any stroke (hemorrhagic/ischemic stroke) in the target blood supply area or all-cause death at 30 days after procedure

The rate of Hemorrhagic stroke as well as symptomatic ischemic stroke and any death in the target blood supply area

Time frame: 30 days after procedure

Rate of any stroke (hemorrhagic/ischemic stroke) in the non-target blood supply area or all-cause death at 30 days after procedure

The rate of Hemorrhagic stroke as well as symptomatic ischemic stroke and any death in the non-target blood supply area

Time frame: 30 days after procedure

Rate of TIA at 30 days, 30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years after procedure

TIA is a temporary blockage of blood flow to the brain with symptoms last from only a few minutes up to 24 hours

Time frame: 30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years after procedure

Rate of any stroke (hemorrhagic/ischemic stroke) in the target blood supply area at 3, 6 months, 1, 2, 3, 4 years and 5 years after procedure

The rate of Hemorrhagic stroke as well as symptomatic ischemic stroke in the target blood supply area

Time frame: 3, 6 months, 1, 2, 3, 4 years and 5 years after procedure

Central Contacts

Xiaoyan Yu

CONTACT

18614030565 yuxiaoyan@sinomed.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.