Clinical trial NCT06857058: Standardized Procedure for Intracranial Drug-Eluting Stenting in the Treatment of Intracranial Atherosclerotic Stenosis
Official title: A Prospective, Multicenter, Registry Study to Evaluate the Safety, Efficacy, and Standardized Procedural Optimization of the Intracranial Drug-Eluting Stent System in Patients with Symptomatic Intracranial Atherosclerotic Stenosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Intracranial Atherosclerotic Stenosis
Keywords: endovascular therapy, intracranial drug-eluting stent
Lead sponsor: Sino Medical Sciences Technology Inc.
Sponsor class: INDUSTRY
Collaborators: name: The First Affiliated Hospital of Zhengzhou University
name: Tongji Hospital
First posted: 2025-03-04
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: 1 year after procedure
Secondary outcomes:
measure: Rate of any stroke (hemorrhagic/ischemic stroke) in the target blood supply area or all-cause death at 30 days after procedure
timeFrame: 30 days after procedure
measure: Rate of any stroke (hemorrhagic/ischemic stroke) in the non-target blood supply area or all-cause death at 30 days after procedure
timeFrame: 30 days after procedure
measure: Rate of TIA at 30 days, 30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years after procedure
timeFrame: 30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years after procedure
measure: 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
timeFrame: 3, 6 months, 1, 2, 3, 4 years and 5 years after procedure
measure: Rate of any stroke (hemorrhagic/ischemic stroke) in the non-target blood supply area at 3, 6 months, 1, 2, 3, 4 years and 5 years after procedure
timeFrame: 3, 6 months, 1, 2, 3, 4 years and 5 years after procedure
measure: Rate of death (vascular/ non-vascular death) at 30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years after procedure
timeFrame: 30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years after procedure
measure: Rate of symptomatic ISR and Revascularization at 30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years after procedure
timeFrame: 30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years after procedure
measure: Rate of modified Rankin Scale (mRS) at 30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years after procedure
timeFrame: 30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years after procedure
measure: EQ-5D score at 30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years after procedure
timeFrame: 30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years after procedure
measure: Rate of in-stent restenosis at 1, 2, 3, 4 years and 5 years after procedure (Optional)
timeFrame: 1, 2, 3, 4 years and 5 years after procedure
measure: Rate of Device defect
timeFrame: within 5 years of whole trial
measure: Rate of bleeding events at 1 years after procedure
timeFrame: 1 year after procedure
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: The first affiliated hospital of zhengzhou university
Study officials:
affiliation: The First Affiliated Hospital of Zhengzhou University
name: Sheng Guan
role: PRINCIPAL_INVESTIGATOR
affiliation: Tongji Hospital
name: Chun Fang
role: PRINCIPAL_INVESTIGATOR
References: