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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorSinomed Neurovita Technology Inc.

About this trial

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

Eligibility criteria

Qualifiers

18 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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • balloon microcatheter

Treatment groups

56 Participants
are divided into 1 treatment group