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ACOART Paclitaxel SVD:Paclitaxel Coated Coronary Balloon Catheter in Treatment of Coronary Small Vessel Diseases

NCT04626687 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 230

Last updated 2024-01-05

No results posted yet for this study

Summary

The purpose of the trial is to determine whether DCB made by Acotec Scientific is not inferior to RESTORE DEB made by CARDIONOVUM GmbH in treatment of small vessel coronary disease.

Conditions

  • Coronary Disease

Interventions

DEVICE

test DCB

use paclitaxel coated coronary balloon catheters to treat SVD

DEVICE

RESTORE DCB

use paclitaxel coated coronary balloon catheters(RESTORE DCB) with NMPA approval indication for treating SVD

Sponsors & Collaborators

  • Shanghai Tongji Hospital, Tongji University School of Medicine

    collaborator OTHER

  • Acotec Scientific Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Xuebo Liu, MD · Shanghai Tongji Hospital, Tongji University School of Medicine

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
2021-04-06
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • China

Study Locations

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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 NCT04626687 on ClinicalTrials.gov