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

NCT ID: NCT07170618

Last Updated: 2025-09-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-01

Study Completion Date

2025-12-30

Brief Summary

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

Detailed Description

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This study is a prospective, multicenter, objective performance criteria clinical trial to evaluate the safety and efficacy of a balloon microcatheter in the treatment of intracranial artery stenosis. A total of 56 patients are planned to be included. The endpoints include device success, target vessel dissection, target vessel occlusion, mortality and cerebrovascular events, assessed during the in-hospital until discharge.

Conditions

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Intracranial Artery Stenosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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balloon microcatheter

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.

Group Type EXPERIMENTAL

balloon microcatheter

Intervention Type DEVICE

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

Interventions

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balloon microcatheter

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. 18 to 80 years of age
2. Patients with intracranial artery stenosis (Degree of stenosis: ≥70%)
3. Target vessel reference diameter must be visually estimated to be 1.25 mm to 4.50 mm
4. Willingness to participate in this clinical trial and signing the consent form for patients or their legally authorised representatives

Exclusion Criteria

1. 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
2. Pre-existing severe respiratory, hepatic, or renal diseases (e.g., creatinine ≥ 3.0 mg/dL) or coagulation disorders
3. Disabling stroke with a baseline mRS score ≥ 3 points
4. Non-atherosclerosis diseases
5. Patients with stroke caused by branch occlusion
6. Patients who were participating in other clinical trials who had not yet reached the primary clinical endpoint
7. Known hypersensitivity to aspirin, heparin, anesthetics and contrast agents
8. Investigators consider the patient who is not suitable for enrolling in the present trial
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sinomed Neurovita Technology Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The Second Affiliated Hospital of Harbin Medical University

Harbin, , China

Site Status

Countries

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China

Central Contacts

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Yong Li Li

Role: CONTACT

13904611005

Facility Contacts

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Yong Li Li

Role: primary

13904611005

Other Identifiers

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SINOMED-BMC-2025

Identifier Type: -

Identifier Source: org_study_id

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