Balloon angiopLasty for Intracranial Atherosclerotic Minor Stroke/TIA: a Prospective, Multi-center, Register Study

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Observational
SUMMARY

The objective of this study was to evaluate the safety and efficacy of early submaximal balloon angioplasty combined with medical therapy vs medical therapy alone for minor stroke/transient ischemic attack with intracranial atherosclerosis etiology.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 30
Maximum Age: 80
View:

• age range of 30-80 years;

• symptomatic ICAS (C4-C7 segments of ICA, M1 segment of the MCA, V4 segment of the VA, and BA) with 70%-99% stenosis confirmed by DSA;

• minor stroke (NIHSS score ≤5) within 1 week of onset or from symptom exacerbation (NIHSS score increased by ≥2 points) or intermediate- to high-risk TIA, defined as ABCD2 score ≥4 within 1 week of the last symptom episode;

• diameter of the culprit artery ranging from 2.0 to 4.5mm, and the length of the stenosis≤14mm;

• mRS ≤ 2 before endovascular treatment;

• no large ischemic region found on CT or MRI (ASPECTS≥ 6 or pc-ASPECTS ≥8);

• written informed consent obtained from the patient or legally responsible person.

Locations
Other Locations
China
The First Hospital of Jilin University
RECRUITING
Changchun
Contact Information
Primary
Shouchun Wang, MD, PhD
WSC@jlu.edu.cn
0086-13596060906
Backup
Huisheng Chen, MD, PhD
chszh@aliyun.com
0086-13352452086
Time Frame
Start Date: 2023-08-23
Estimated Completion Date: 2026-12-01
Participants
Target number of participants: 416
Treatments
Observation group
The observation group received early submaximal balloon angioplasty and medical therapy.
Control group
The control group received only medical therapy.
Related Therapeutic Areas
Sponsors
Leads: Shouchun Wang, MD, PhD
Collaborators: The General Hospital of Northern Theater Command

This content was sourced from clinicaltrials.gov