The Efficacy and Safety of Intracranial Self-expanding DES in Symptomatic Intracranial Atherosclerotic Disease

NCT05217459 | Completed

• 1 other identifier: SNSC-202103
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 14

Brief Summary

The primary objective of this trial is to evaluate the safety and efficacy of SINOMED IS- DES in patients with symptomatic intracranial atherosclerotic stenosis.

Conditions

Intracranial Arterial Diseases; Stent Restenosis; Percutaneous Transluminal Angioplasty

Keywords

Self-expanding intracranial stent; Symptomatic Intracranial Atherosclerotic Disease; In-stent restenosis

Outcome Measures

Primary Outcomes (1)

• The incidence of In-stent restenosis within 6 months after operation

  ISR is defined as stenosis greater than 50% within or immediately adjacent (within 5 mm) to the implanted stents and absolute luminal loss greater than 20% at 6 months follow-up imaging.

  6 months after operation

Secondary Outcomes (15)

• Stent success

  Immediately after operative

• Procedure success

  Immediately after operative

• Percent of Participants With National Institutes of Health Stroke Scale (NIHSS) Score = 0 or 1 at 6 months follow-up

  6 months after operation

• Rate of good functional outcomes measured by Modified Rankin Score (mRS)

  30days, 6 months, 1 year after operation

• Rate of all revascularization and target lesion revascularization

  30days, 31days to 6 months, 1 year after operation

Study Arms (1)

Self-expanding intracranial drug stent system

EXPERIMENTAL

All patients receive Percutaneous transluminal angioplasty and stenting with self-expanding intracranial drug stent system (Temporary abbreviations: SINOMED IS-DES)

Device: Self-expanding intracranial drug stent system

Interventions

Self-expanding intracranial drug stent system DEVICE

All patients receive Percutaneous transluminal angioplasty and stenting with self-expanding intracranial drug stent system (Temporary abbreviations: SINOMED IS-DES)

Self-expanding intracranial drug stent system

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 75 years of age;
• Patients with symptomatic intracranial atherosclerotic stenosis who failed antiplatelet therapy or poor collateral circulation compensation or hypoperfusion in the territory of the culprit artery;
• Digital Subtraction Angiography(DSA) showed 70% to 99% stenosis in target intracranial artery
• The target lesion was in the internal carotid artery (intracranial segment), middle cerebral artery, vertebral artery (intracranial segment), basilar artery, and it was a single lesion that required surgical treatment;
• The target lesion reference diameter must be visually estimated to be ≥2.0 mm and \<4.5mm in diameter, and lesion length of ≤34 mm;
• mRS \< 3;
• The onset of the latest transient ischemic attack (TIA) was not limited or ischemic stroke occurred within 2 weeks prior to stenting procedure;
• Willingness to participate in this clinical trial and signing the consent form, and be able to complete the corresponding inspections, follow-ups, etc. according to the requirements of the clinical protocol during the clinical trial.

You may not qualify if:

• The target vessels was complete occlusion;
• \>70% stenosis observed at the intracranial large-vessel distal to the target vessel or \>70% stenosis observed at the intracranial/extracranial large-vessel proximal to the target vessel;
• Preoperative magnetic resonance only showed perforating infarction in the target lesion area;
• Preoperative CT or MRI showed that there was hemorrhage transformation after infarction in the target vessel area, or a history of primary cerebral hemorrhage, or a history of subarachnoid, subdural and epidural hemorrhage within 30 days before operation, or there was no treatment Chronic subdural hematoma ≥5mm;
• Hospitalized surgical treatment within 30 days before operation, or planned hospitalized surgical treatment within 6 months after surgery;
• CT showed Severe calcified lesions;
• Previously received endovascular treatment or surgical intervention at the target vessel (except for patients with simple balloon dilatation);
• Non-atherosclerosis lesions;
• Patients with potential sources of cardiac embolism (such as atrial fibrillation, left ventricular thrombosis, myocardial infarction within 6 weeks);
• Concomitant intracranial tumor, aneurysm or intracranial arteriovenous malformation;
• Known hypersensitivity to aspirin, heparin, clopidogrel, rapamycin (sirolimus), lactic acid polymer, poly-n-butyl methacrylate, nickel-titanium alloy, or contraindications to anesthetics and contrast agents;
• Hemoglobin \<100g/L, platelet count \<100\*109/L, International normalized ratio (INR) \>1.5 (irreversible) or uncorrectable hemorrhagic factors;
• Uncontrollable severe hypertension (systolic blood pressure\>180mmHg or diastolic blood pressure\>110mmHg)；
• Known liver or renal insufficiency (ALT\> 3x upper limit or AST \> 3x upper limit, Serum creatinine\>250μmol/L);
• Life expectancy \< 1 year;

Sponsors & Collaborators

• Sinomed Neurovita Technology Inc.: lead
• Changhai Hospital: collaborator

Study Sites (14)

Beijing Chao-Yang Hospital, Capital Medical University

Beijing, China

Location

The First Hospital of Jilin University

Changchun, China

Location

The First People's Hospital of Changzhou

Changzhou, China

Location

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, China

Location

Hangzhou First people's Hospital, Zhejiang University School of Medicine

Hangzhou, China

Location

The First Affiliated Hospital of Harbin Medical University

Ha’erbin, China

Location

The First Affiliated Hospital of USTC Anhui provincial hospital

Hefei, China

Location

Qilu Hospital, Shandong University

Jinan, China

Location

The Affiliated Hospital of Qingdao University

Qingdao, China

Location

Changhai Hospital

Shanghai, China

Location

Shanghai Fourth People's Hospital

Shanghai, China

Location

The First Hospital of Hebei Medical University

Shijiazhuang, China

Location

Yantai Yu Huang Ding hospital

Yantai, China

Location

The First Affiliated hospital of Zhengzhou hospital

Zhengzhou, China

Location

MeSH Terms

Conditions

Intracranial Arterial Diseases

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• jianming Liu, M.D/Ph.D

  Changhai Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2022
• First Posted: February 1, 2022
• Study Start: July 4, 2022
• Primary Completion: August 17, 2023
• Study Completion: March 29, 2024
• Last Updated: May 21, 2025

Record last verified: 2024-05

Locations

CN (14)