Drug- Eluting Stent for Symptomatic Intracranial Arterial Stenosis
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorBeijing Tiantan Hospital
About this trial
This investigation is a prospective, multicenter, randomized controlled, non-inferiority clinical trial, to evaluate the safety and efficacy of the investigational device against alternative models/specifications of the control device. The study will be conducted across multiple Chinese centers, with planned enrollment of 224 patients with symptomatic intracranial atherosclerotic stenosis. Subjects meeting all inclusion criteria and without any exclusion criteria will enter the investigation after providing written informed consent via ethics committee-approved informed consent forms (ICFs). The randomized controlled study plans to enroll 224 patients, stratified by intracranial lesion location (anterior/posterior circulation), through a centralized randomization system. The experimental group will receive the NxiDIME™ Intracranial Drug-Eluting Stent System (RICOTON Technology Co., Ltd.), while the control group will receive the NOVADES® Intracranial Drug-Eluting Stent System.
All subjects underwent follow-up visits on the day of the procedure, within 7 days postoperatively or prior to discharge, and at 30 days, 6 months, and 12 months postoperatively.
Eligibility criteria
Qualifiers
Age ≥ 18 years old and ≤ 80 years old, regardless of gender.
Symptomatic intracranial arterial stenosis (TIA/ischemic stroke within 180 days attributed to intracranial arteries including the intracranial internal carotid artery, middle cerebral artery, intracranial vertebral artery, or basilar artery, with stenosis severity ≥70% and ≤99% measured by DSA using WASID criteria), currently receiving at least one antiplatelet therapy;
Poor collateral circulation or hypoperfusion in the target vessel territory (Poor collateral circulation: American Society of Interventional and Therapeutic Neuroradiology/Society of Interventional Radiology (ASITN/SIR) score < 3; Hypoperfusion: 1. The cerebral blood flow (CBF) in the target artery territory decreases by > 30% during CT or magnetic resonance perfusion imaging (MR perfusion); or 2. There are hemodynamic ischemic lesions on MRI or CT, such as watershed infarction);
Target lesion vessel diameter 1.0-5.5 mm with lesion length ≤40 mm (If: 2.25 mm ≤ target vessel diameter ≤4.0 mm and lesion length ≤15 mm, enroll in randomized controlled study; 1.0 mm ≤ target vessel diameter <2.25 mm or 4.0 mm < target vessel diameter ≤5.5 mm or 15 mm < lesion length ≤40 mm, enroll in single-arm cohort study);
Disqualifiers
History of prior stent implantation or surgical treatment at the target lesion;
Intracranial hemorrhage within 30 days preoperatively or presence of untreated chronic subdural hematoma ≥5 mm;
Major surgical procedure within 30 days prior to the procedure;
Acute ischemic stroke within 14 days prior to the procedure;
Trial design
Treatments tested in this trial
- NxiDIME™ Intracranial Drug-Eluting Stent System
- NOVA DES Intracranial Drug-Eluting Stent
Treatment groups
224 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov