Symptomatic Intracranial Atherosclerotic StenosisNCT07542938
Medeliver Intracranial Drug Coated Balloon Catheter for Symptomatic Intracranial Atherosclerotic Stenosis
A study testing Intracranial Drug-Coated Balloon Catheter (Medeliver®) and Intracranial Balloon Dilatation Catheter (Diveroad®) in people with Symptomatic Intracranial Atherosclerotic Stenosis, run by Xuanwu Hospital, Beijing at 15 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Symptomatic Intracranial Atherosclerotic Stenosis
- What is being tested?
- Intracranial Drug-Coated Balloon Catheter (Medeliver®) and Intracranial Balloon Dilatation Catheter (Diveroad®)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 264 participants
- Where
- 15 sitesChina
- Study dates
- 15 Apr 2026to 30 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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;
- Pregnant, breastfeeding, or planning pregnancy within 1 year;
- Life expectancy < 1 year;
- Participation in another drug or device clinical trial currently or planned during the study period;
- Intracranial stenosis due to non-atherosclerotic etiology (e.g., arterial dissection, moyamoya disease, vasculitis, active arteritis, thrombosis);
- Severe or unstable comorbidities (e.g., severe heart failure, respiratory failure, renal failure [serum creatinine > 3.0 mg/dL or 264 µmol/L], severe hepatic impairment [ALT/AST > 3 × ULN], active malignancy);
- Flow-limiting dissection or residual stenosis > 50% after pre-dilatation;
- Any other condition that, in the investigator's judgment, makes the patient unsuitable for enrollment;
Trial locations and contacts
15 sites in 1 country. Contact the study team or a site near you to ask about taking part.
15 sites in 1 country
China15 sites, 15 recruiting
- Recruiting
包头市中心医院
Baotou, Inner Mongolia, 014040
Changchun Jiang
- Recruiting
首都医科大学宣武医院
Beijing, Beijing Municipality, 100053
Fei Chen
- Recruiting
福建医科大学附属协和医院
Fuzhou, Fujian, 350001
Wenhuo Chen
- Recruiting
哈尔滨医科大学附属第一医院
Harbin, Heilongjiang, 150001
Huaizhang Shi
- Recruiting
山东大学齐鲁医院
Ji'nan, Shandong, 250012
Wei Wu
- Recruiting
济南市中心医院
Ji'nan, Shandong, 250013
Yanxin Zhao
- Recruiting
山东省立医院（包含老院区及东院区）
Ji'nan, Shandong, 250021
Qinjian Sun
- Recruiting
南阳市中心医院
Nanyang, Henan, 473000
Jun Sun
- Recruiting
青岛大学附属医院
Qingdao, Shandong, 266003
Yong Zhang
- Recruiting
复旦大学附属华山医院（包含总院及西院区）
Shanghai, Shanghai Municipality, 200040
Jiabin Su
- Recruiting
上海交通大学医学院附属仁济医院
Shanghai, Shanghai Municipality, 200127
Jieqing Wan
- Recruiting
河北省人民医院
Shijiazhuang, Hebei, 050051
Guodong Xu
- 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
Jianfeng Han
- Recruiting
河南省人民医院（包含总院及北院区）
Zhengzhou, Henan, 450003
Liangfu Zhu
- 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
Sheng Guan
About this study
Official title: Safety and Efficacy of Medeliver Intracranial Drug Coated Balloon Catheter for Symptomatic Intracranial Atherosclerotic Stenosis(Prospective, Multicenter, Randomized Controlled, Superiority Trial)
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.
- Being tested
- Intracranial Drug-Coated Balloon Catheter (Medeliver®), Intracranial Balloon Dilatation Catheter (Diveroad®)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Test group | Experimental | Intervention: Medeliver® Intracranial Drug-Coated Balloon Catheter Manufacturer: Beijing JSSK Neuro Medical Co., Ltd. Receives: Device: Intracranial Drug-Coated Balloon Catheter (Medeliver®) |
| Control Group | Active comparator | Intervention: Diveroad® Intracranial Balloon Dilatation Catheter Manufacturer: Beijing JSSK Neuro Medical Co., Ltd. Receives: Device: Intracranial Balloon Dilatation Catheter (Diveroad®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The 12-month post-procedural rates of target lesion restenosis, stroke recurrence or mortality in the territory of the target vessel.
Measured: From enrollment to the end of follow-up at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2026
- Study start15 Apr 2026
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Symptomatic Intracranial Atherosclerotic StenosisStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 264 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fei Chen, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07542938
- Sponsor's protocol ID
- JSSKBMCT005
- Status last verified
- Sep 2026
- First submitted
- 6 Apr 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Medeliver Intracranial Drug Coated Balloon Catheter for Symptomatic Intracranial Atherosclerotic Stenosis(Prospective, Multicenter, Randomized Controlled, Superiority Trial)
- ClinicalTrials.gov ID
- NCT07542938
- Acronym / sponsor ID
- JSSKBMCT005
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 264 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 15 Apr 2026 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 21 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test group | Experimental | Device: Intracranial Drug-Coated Balloon Catheter (Medeliver®)Intervention: Medeliver® Intracranial Drug-Coated Balloon Catheter Manufacturer: Beijing JSSK Neuro Medical Co., Ltd. |
| Control Group | Active comparator | Device: Intracranial Balloon Dilatation Catheter (Diveroad®)Intervention: Diveroad® Intracranial Balloon Dilatation Catheter Manufacturer: Beijing JSSK Neuro Medical Co., Ltd. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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；
Key exclusion criteria (22 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intracranial Drug-Coated Balloon Catheter (Medeliver®)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. | Device | Test group |
| Intracranial Balloon Dilatation Catheter (Diveroad®)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. | Device | Control Group |
Primary outcome
The 12-month post-procedural rates of target lesion restenosis, stroke recurrence or mortality in the territory of the target vessel.
Time frame: From enrollment to the end of follow-up at 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intracranial Drug-Coated Balloon Catheter (Medeliver®) and Intracranial Balloon Dilatation Catheter (Diveroad®) in people with Symptomatic Intracranial Atherosclerotic Stenosis, run by Xuanwu Hospital, Beijing at 15 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhen Li Beijing Highland Med-Tech Development Co.,Ltd (18611537116, jason.lee@hld-cro.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The 12-month post-procedural rates of target lesion restenosis, stroke recurrence or mortality in the territory of the target vessel. (time frame: From enrollment to the end of follow-up at 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.