Medeliver Intracranial Drug Coated Balloon Catheter for Symptomatic Intracranial Atherosclerotic Stenosis

Official title

Safety and Efficacy of Medeliver Intracranial Drug Coated Balloon Catheter for Symptomatic Intracranial Atherosclerotic Stenosis(Prospective, Multicenter, Randomized Controlled, Superiority Trial)

Overview

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.

Interventions

• Device 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 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.

Primary outcome measures

• 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]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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;
• 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;

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07542938 · JSSKBMCT005

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗