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Acoart SCB SFA: Sirolimus Coated Balloon Catheter in the Treatment of Femoropopliteal Artery Stenosis

NCT04982367 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 166

Last updated 2023-10-18

No results posted yet for this study

Summary

A prospective randomized trial designed to compare the efficacy and safety of Sirolimus coated balloon (SCB) versus paclitaxel coated balloon (DCB) in the treatment of femoropopliteal artery stenosis

Conditions

Interventions

DEVICE

Sirolimus-eluting balloon catheter

Sirolimus-eluting balloon catheter designed and produced by Acotec

DEVICE

Paclitaxel-eluting balloon catheter

Paclitaxel-eluting balloon catheter (trade name:DHALIA)

Sponsors & Collaborators

  • Acotec Scientific Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Guo Wei, MD · Chinese PLA General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-12-08
Primary Completion
2024-07-31
Completion
2024-07-31

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 NCT04982367 on ClinicalTrials.gov