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ACOART Intracranial ISR Pilot:Intracranial DCB in the Treatment of Intracranial In-stent Restenosis

NCT04627870 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-08-01

No results posted yet for this study

Summary

The purpose of the study is to evaluate the safety and feasibility of drug coated balloon in treatment of intracranial in-stent restenosis.

Conditions

  • Intracranial Atherosclerosis
  • Stroke

Interventions

DEVICE

drug (paclitaxel) coated balloon

use drug (paclitaxel) coated balloon catheter to treat intracranial in-stent restenosis

DEVICE

PTA balloon

use traditional PTA balloon with NMPA approval of indication for treating intracranial stenosis

Sponsors & Collaborators

  • Beijing Tiantan Hospital

    collaborator OTHER

  • Acotec Scientific Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Ning Ma, 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
2021-05-26
Primary Completion
2024-12-30
Completion
2025-12-30

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 NCT04627870 on ClinicalTrials.gov