Efficacy and Safety of a New Balloon Microcatheter in the Treatment of Intracranial Artery Stenosis

NCT07170618 | Not Yet Recruiting

• 1 other identifier: SINOMED-BMC-2025
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this trial is to evaluate the safety and efficacy of a new balloon microcatheter in patients with intracranial artery stenosis.

Conditions

Intracranial Artery Stenosis

Outcome Measures

Primary Outcomes (1)

• Rate of device success

  The system was successfully delivered to the target site, the balloon was successfully inflated at the lesion area, the therapeutic device was successfully delivered via the microcatheter, and the system was successfully withdrawn.

  During interventional procedure

Secondary Outcomes (5)

• Incidence of cerebrovascular events, including transient ischemic attack (TIA), ischemic stroke, and hemorrhagic stroke.

  Perioperatively (During the in-hospital until discharge)

• Rate of target vessel dissection, target vessel occlusion

  Perioperatively (During interventional procedure)

• Mortality

  Perioperatively (During the in-hospital until discharge)

• Proportion of adverse events or severe adversary event

  Perioperatively (During the in-hospital until discharge)

• Incidence of device defects

  Perioperatively (During the in-hospital until discharge)

Study Arms (1)

balloon microcatheter

EXPERIMENTAL

For the treatment of intracranial artery stenosis, balloon microcatheter would combine the advantages of balloon dilatation first and then, if necessary, the additional deployment of a self-expandable stent via the same balloon microcatheter lumen.

Device: balloon microcatheter

Interventions

balloon microcatheter DEVICE

The balloon microcatheter simultaneously possesses both balloon dilatation and device delivery functions.

balloon microcatheter

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 80 years of age
• Patients with intracranial artery stenosis (Degree of stenosis: ≥70%)
• Target vessel reference diameter must be visually estimated to be 1.25 mm to 4.50 mm
• Willingness to participate in this clinical trial and signing the consent form for patients or their legally authorised representatives

You may not qualify if:

• The proximal end of the target vessel is extremely tortuous, severely angulated, or heavily calcified, making it difficult for the device to reach the target vessel
• Pre-existing severe respiratory, hepatic, or renal diseases (e.g., creatinine ≥ 3.0 mg/dL) or coagulation disorders
• Disabling stroke with a baseline mRS score ≥ 3 points
• Non-atherosclerosis diseases
• Patients with stroke caused by branch occlusion
• Patients who were participating in other clinical trials who had not yet reached the primary clinical endpoint
• Known hypersensitivity to aspirin, heparin, anesthetics and contrast agents
• Investigators consider the patient who is not suitable for enrolling in the present trial

Sponsors & Collaborators

• Sinomed Neurovita Technology Inc.: lead

Study Sites (1)

The Second Affiliated Hospital of Harbin Medical University

Harbin, China

Location

Central Study Contacts

Yong Li Li

CONTACT

13904611005; liyongli9999@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2025
• First Posted: September 12, 2025
• Study Start: September 1, 2025
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: September 12, 2025

Record last verified: 2025-08

Locations

CN (1)