Efficacy and Safety of a New Balloon Microcatheter in the Treatment of Intracranial Artery Stenosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: balloon microcatheter.
- Who it may be relevant to
- Registry conditions: Intracranial Artery Stenosis. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Prospective, Multicenter, Objective Performance Criteria Study to Evaluate the Efficacy and Safety of a Balloon Microcatheter for Clinical Use
Overview
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
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.
Interventions
- Device balloon microcatheter
The balloon microcatheter simultaneously possesses both balloon dilatation and device delivery functions.
Primary outcome measures
- Rate of device success [Time frame: During interventional procedure]
Secondary outcome measures (5)
- Incidence of cerebrovascular events, including transient ischemic attack (TIA), ischemic stroke, and hemorrhagic stroke. [Time frame: Perioperatively (During the in-hospital until discharge)]
- Rate of target vessel dissection, target vessel occlusion [Time frame: Perioperatively (During interventional procedure)]
- Mortality [Time frame: Perioperatively (During the in-hospital until discharge)]
- Proportion of adverse events or severe adversary event [Time frame: Perioperatively (During the in-hospital until discharge)]
- Incidence of device defects [Time frame: Perioperatively (During the in-hospital until discharge)]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- The Second Affiliated Hospital of Harbin Medical University — Harbin
Identifiers
NCT: NCT07170618 · SINOMED-BMC-2025