AcoArt Ⅱ/ BTK China: Drug-eluting Balloon for Below-The-Knee Angioplasty Evaluation in China

NCT02137577 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2021-06-18

No results posted yet for this study

Summary

The purpose of this study is to determine whether DEB is more effective than common PTA balloon using under in long-term vessel patency and inhibiting restenosis in the infrapopliteal artery.

Conditions

Interventions

PROCEDURE

DEB catheter

DEB catheter (trade name: Litos/Tulip)

PROCEDURE

common PTA balloon catheter

common PTA balloon catheter

Sponsors & Collaborators

  • Acotec Scientific Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Wei Guo · Chinese PLA General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2018-11-30
Completion
2020-12-17

Countries

  • China

Study Locations

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Entities

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 NCT02137577 on ClinicalTrials.gov