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AcoArt sICAS: DCB in the Treatment of Symptomatic Intracranial Atherosclerotic Stenosis

NCT04631055 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2024-08-23

No results posted yet for this study

Summary

The purpose of the RCT trial is to determine whether DCB is not inferior to stent in treating intracranial stenosis.

Conditions

  • Intracranial Atherosclerosis
  • Stroke

Interventions

DEVICE

drug coated balloon

paclitaxel coated balloon catheter for intracranial PTA treatment

DEVICE

stent system

The Intracranial Stent System comprises of a balloon expandable stent and a delivery catheter that features a rapid exchange catheter design with a semi-compliant balloon located at its distal end.The product, APOLLO™ stent system, has the indication of endovascular treatment for intracranial stenosis approved by NMPA.

Sponsors & Collaborators

  • Beijing Tiantan Hospital

    collaborator OTHER

  • Acotec Scientific Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Zhongrong Miao, MD · Beijing Tiantan Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-04
Primary Completion
2023-04-10
Completion
2023-04-13

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04631055 on ClinicalTrials.gov