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A Safety and Efficacy Study of Lepu® Drug Coated Balloon in Treatment of Coronary Small-vessel Disease

NCT04953117 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 286

Last updated 2021-07-07

No results posted yet for this study

Summary

This study was designed to verify the safety and efficacy of Lepu® Drug Coated Balloon in Treatment of Coronary Small-vessel Disease

Conditions

Interventions

DEVICE

DCB of Lepu Medical(dimeter≥2.00 mm)

subjects receiving DCB of Lepu Medical(dimeter≥2.00 mm)

DEVICE

Restore DEB

subjects receiving Restore DEB

DEVICE

DCB of Lepu Medical(dimeter<2.00 mm)

subjects receiving DCB of Lepu Medical(dimeter\<2.00 mm)

Sponsors & Collaborators

  • Lepu Medical Technology (Beijing) Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Yida Tang · Peking University Third Hospital

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
2021-03-10
Primary Completion
2022-06-30
Completion
2023-04-30

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 NCT04953117 on ClinicalTrials.gov