Drug- Eluting Stent for Symptomatic Intracranial Arterial Stenosis

NCT ID: NCT07197970

Last Updated: 2025-09-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 224 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-15
• Study Completion Date: 2027-05-15

Brief Summary

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.

Conditions

Symptomatic Intracranial Atherosclerotic Stenosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental group

Endovascular angioplasty with NxiDIME™ Intracranial Drug-Eluting self-expanding Stent System

Group Type: EXPERIMENTAL

NxiDIME™ Intracranial Drug-Eluting Stent System

Intervention Type: DEVICE

The experimental group will receive the NxiDIME™ Intracranial Drug-Eluting self-expanding Stent System (RICOTON Technology Co., Ltd.)

Controal group

Endovascular angioplasty with NOVA Intracranial Drug-Eluting Balloon-expandable Stent

Group Type: ACTIVE_COMPARATOR

NOVA DES Intracranial Drug-Eluting Stent

Intervention Type: DEVICE

The experimental group will receive the NOVA DES Intracranial Drug-Eluting balloon-expandable stent System

Interventions

NxiDIME™ Intracranial Drug-Eluting Stent System

The experimental group will receive the NxiDIME™ Intracranial Drug-Eluting self-expanding Stent System (RICOTON Technology Co., Ltd.)

Intervention Type: DEVICE

NOVA DES Intracranial Drug-Eluting Stent

The experimental group will receive the NOVA DES Intracranial Drug-Eluting balloon-expandable stent System

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Age ≥ 18 years old and ≤ 80 years old, regardless of gender.

2. 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;

3. 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);

4. 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);

5. mRS score ≤ 2;

6. Patient or legal guardian voluntarily participates and signs the written ICF, with willingness to comply with protocol-specified examinations and follow-up.

Exclusion Criteria

1. History of prior stent implantation or surgical treatment at the target lesion;

2. Intracranial hemorrhage within 30 days preoperatively or presence of untreated chronic subdural hematoma ≥5 mm;

3. Major surgical procedure within 30 days prior to the procedure;

4. Acute ischemic stroke within 14 days prior to the procedure;

5. Symptomatic carotid stenosis ≥50% outside the target lesion, or coexisting intracranial/extracranial vascular stenosis ≥70% requiring intervention;

6. Severe calcification, significant stenosis, or tortuosity of the target vessel precluding device deployment as assessed by investigators;

7. Intracranial tumor, arteriovenous malformation, or tandem aneurysms proximal/distal to the target lesion;

8. Non-atherosclerotic stenosis etiology (e.g., arterial dissection, moyamoya disease, vasculitis);

9. Cardiac thromboembolic sources (e.g., atrial fibrillation, left ventricular thrombus, myocardial infarction within 6 weeks);

10. Uncontrolled hypertension (persistent systolic blood pressure (SBP) ≥180 mmHg or diastolic blood pressure (DBP) ≥110 mmHg);

11. Contraindications to antiplatelet/anticoagulant therapy, coagulopathy or bleeding diathesis precluding intervention per investigator judgment;

12. Severe comorbidities: cardiac failure (New York Heart Association (NYHA) Class III-IV), respiratory/renal failure (serum creatinine >3.0 mg/dL (264 μmol/L)), Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) more than 3 times the upper limit of the normal value), active malignancy;

13. Hypersensitivity to rapamycin, polylactic-co-glycolic acid, nitinol, platinum-tungsten, anesthetics, or contrast agents;

14. Life expectancy <1 year;

15. Pregnancy, lactation, or planned pregnancy within 1 year;

16. Concurrent participation in other clinical trials without completing primary endpoint follow-up;

17. Cognitive impairment or psychiatric disorders compromising protocol compliance; other exclusionary conditions per investigator discretion.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Tiantan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Feng Gao

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

A prospective, multi-center, randomized controlled, non-inferiority clinical trial to evaluate the safety and efficacy of the NxiDIME™ Intracranial Drug-Eluting Stent System in the treatment of symptomatic intracranial atherosclerotic stenosis lesions

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Feng Gao, Ph.D

Role: CONTACT

geofengletter@sina.com

13581936066

Ming Yang

Role: CONTACT

wireyang20@163.com

13331060083

Facility Contacts

Ming Yang, Ph.D

Role: primary

wireyang20@163.com

13331060083

Other Identifiers

QX2025-002-01

Identifier Type: -

Identifier Source: org_study_id