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ACOART SCB BIF: Treatment of Coronary Bifurcation Lesion by Sirolimus Coated Balloon vs Paclitaxel Coated Balloon

NCT04899583 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 230

Last updated 2023-11-29

No results posted yet for this study

Summary

The aim of this randomized controlled trial is to examine the treatment of coronary bifurcation lesion with a sirolimus coated balloon versus a paclitaxel coated balloon. This trial is designed as prospective, multicenter, randomized and open-label.

Conditions

  • Coronary Bifurcation Lesions

Interventions

DEVICE

Sirolimus Coated Balloon Catheter

a Sirolimus Coated Balloon Catheter designed and produced by Acotec

DEVICE

a Paclitaxel Coated Balloon Catheter

a Paclitaxel Coated Balloon Catheter(trade name:Bingo)

Sponsors & Collaborators

  • Shanghai Zhongshan Hospital

    collaborator OTHER

  • Acotec Scientific Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Ge Junbo · Shanghai Zhongshan 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
2021-11-10
Primary Completion
2024-11-01
Completion
2025-11-01

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 NCT04899583 on ClinicalTrials.gov