NCT07542938

Brief Summary

To evaluate the safety and efficacy of the Medeliver® Intracranial Drug-Coated Balloon Catheter (developed by Beijing Jiu Shi Shen Kang Medical Technology Co., Ltd.) in the endovascular treatment of symptomatic intracranial atherosclerotic stenosis.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
264

participants targeted

Target at P75+ for not_applicable

Timeline
14mo left

Started Apr 2026

Geographic Reach
1 country

15 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress29%
Apr 2026Nov 2027

First Submitted

Initial submission to the registry

April 6, 2026

Completed
9 days until next milestone

Study Start

First participant enrolled

April 15, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 21, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2027

Last Updated

September 10, 2026

Status Verified

September 1, 2026

Enrollment Period

8 months

First QC Date

April 6, 2026

Last Update Submit

September 6, 2026

Conditions

Symptomatic Intracranial Atherosclerotic Stenosis

Outcome Measures

Primary Outcomes (1)

  • The 12-month post-procedural rates of target lesion restenosis, stroke recurrence or mortality in the territory of the target vessel.

    From enrollment to the end of follow-up at 12 months

Study Arms (2)

Test group

EXPERIMENTAL

Intervention: Medeliver® Intracranial Drug-Coated Balloon Catheter Manufacturer: Beijing JSSK Neuro Medical Co., Ltd.

Device: Intracranial Drug-Coated Balloon Catheter (Medeliver®)

Control Group

ACTIVE COMPARATOR

Intervention: Diveroad® Intracranial Balloon Dilatation Catheter Manufacturer: Beijing JSSK Neuro Medical Co., Ltd.

Device: Intracranial Balloon Dilatation Catheter (Diveroad®)

Interventions

Intracranial Drug-Coated Balloon Catheter (Medeliver®)DEVICE

The Medeliver® intracranial drug-coated balloon dilatation catheter is indicated for interventional treatment of symptomatic intracranial atherosclerotic stenosis lesions. It restores the original vascular lumen through balloon dilatation of the stenotic segment while simultaneously delivering an anti-proliferative agent (sirolimus/rapamycin) coated on the balloon surface to the lesion site.

Test group
Intracranial Balloon Dilatation Catheter (Diveroad®)DEVICE

The Diveroad® intracranial balloon dilatation catheter is indicated for interventional treatment of symptomatic intracranial atherosclerotic stenosis lesions. It restores the original vascular lumen through balloon dilatation of the stenotic segment.

Control Group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-80 years;
  • Symptomatic intracranial arterial stenosis within the past 6 months, with 70%-99% diameter stenosis on angiography (per WASID criteria);
  • Target lesion located in: intracranial segment of the internal carotid artery (C3 or above), M1/M2 segment of the middle cerebral artery, basilar artery, or intracranial segment of the vertebral artery;
  • At least one atherosclerotic risk factor (history or current hypertension, diabetes mellitus, hyperlipidemia, hyperhomocysteinemia, smoking, or alcohol consumption);
  • Reference vessel diameter adjacent to the target lesion ≥ 2 mm；
  • Baseline mRS score ≤ 2;
  • Patient or legally authorized representative understands the study purpose, voluntarily agrees to participate, provides written informed consent, and is willing and able to comply with follow-up visits.

You may not qualify if:

  • Acute ischemic stroke within 2 weeks prior to screening;
  • Major surgery or acute myocardial infarction within 30 days prior to screening;
  • Intracranial hemorrhage (parenchymal, subarachnoid, subdural, or extradural) within 3 months prior to screening;
  • Uncontrolled hypertension despite medical therapy (systolic BP ≥ 180 mmHg or diastolic BP ≥ 110 mmHg);
  • Coexisting intracranial tumor, intracranial aneurysm requiring treatment, or arteriovenous malformation;
  • Previous stenting of the target lesion or any intracranial stenting/endovascular procedure within the past 3 months;
  • Cardioembolic stroke;
  • Stroke caused solely by perforator artery occlusion;
  • Two or more consecutive lesions with ≥ 70% stenosis in the target vessel;
  • Additional de novo or in-stent restenosis lesions (\> 70% diameter stenosis);in other intracranial arteries requiring treatment during the same session;
  • Severe calcification, extreme angulation, severe tortuosity, or other anatomical features in the target vessel that may prevent safe device delivery or retrieval;
  • Known allergy or contraindication to heparin, sirolimus (rapamycin), iodinated contrast, aspirin, clopidogrel, or local anesthetics;
  • Gastrointestinal bleeding within 6 months prior to informed consent, rendering antiplatelet therapy unsafe;
  • Platelet count \< 90 × 10⁹/L;
  • INR \> 1.5;
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

首都医科大学宣武医院

Beijing, Beijing Municipality, 100053, China

RECRUITING

福建医科大学附属协和医院

Fuzhou, Fujian, 350001, China

RECRUITING

河北省人民医院

Shijiazhuang, Hebei, 050051, China

RECRUITING

哈尔滨医科大学附属第一医院

Harbin, Heilongjiang, 150001, China

RECRUITING

南阳市中心医院

Nanyang, Henan, 473000, China

RECRUITING

河南省人民医院（包含总院及北院区）

Zhengzhou, Henan, 450003, China

RECRUITING

郑州大学第一附属医院（包含河医院区、郑东院区、南院区）

Zhengzhou, Henan, 450052, China

RECRUITING

包头市中心医院

Baotou, Inner Mongolia, 014040, China

RECRUITING

西安交通大学第一附属医院（包含总院及港务院区）

Xi'an, Shaanxi, 710061, China

RECRUITING

山东大学齐鲁医院

Ji'nan, Shandong, 250012, China

RECRUITING

济南市中心医院

Ji'nan, Shandong, 250013, China

RECRUITING

山东省立医院（包含老院区及东院区）

Ji'nan, Shandong, 250021, China

RECRUITING

青岛大学附属医院

Qingdao, Shandong, 266003, China

RECRUITING

复旦大学附属华山医院（包含总院及西院区）

Shanghai, Shanghai Municipality, 200040, China

RECRUITING

上海交通大学医学院附属仁济医院

Shanghai, Shanghai Municipality, 200127, China

RECRUITING

Central Study Contacts

Zhen Li Beijing Highland Med-Tech Development Co.,Ltd

CONTACT

18611537116jason.lee@hld-cro.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Chief Physician

Study Record Dates

First Submitted

April 6, 2026

First Posted

April 21, 2026

Study Start

April 15, 2026

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

November 30, 2027

Last Updated

September 10, 2026

Record last verified: 2026-09

Locations

CN(15)