Medeliver Intracranial Drug Coated Balloon Catheter for Symptomatic Intracranial Atherosclerotic Stenosis

NCT07542938 | Not Yet Recruiting

• 1 other identifier: JSSKBMCT005
• Study Type: interventional
• Target: 264
• Locations: 0 countries
• Sites: N/A

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.

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

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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;

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Central Study Contacts

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

CONTACT

18611537116; jason.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: April 21, 2026

Record last verified: 2026-04