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The Safety and Efficacy of DIOR Balloon in Coronary Bifurcation Lesions

NCT03820622 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2019-01-31

No results posted yet for this study

Summary

To evaluate the safety and effectiveness of paclitaxel-eluting coronary artery balloon dilation catheter (DIOR) in revascularization of coronary bifurcation lesions compared with paclitaxel-eluting balloon (Bingo), and to provide the clinical data for the formal application in China and for the approvement of China marketing.

Conditions

  • Percutaneous Coronary Intervention

Interventions

DEVICE

Paclitaxel-Eluting Coronary Balloon Dilation Catheter (DIOR)

patients in the study group will be treated by the Paclitaxel-Eluting Coronary Balloon Dilation Catheter (DIOR)

DEVICE

Paclitaxel-Eluting Balloon (Bingo)

patients in the study group will be treated by the Paclitaxel-Eluting Balloon (Bingo)

Sponsors & Collaborators

  • CCRF Inc., Beijing, China

    lead INDUSTRY

Principal Investigators

  • Yaling Han, professor · The General Hospital of Northern Theater Command

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
2019-03-31
Primary Completion
2022-05-31
Completion
2022-10-31

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 NCT03820622 on ClinicalTrials.gov