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Drug-coated Balloon Versus Drug-eluting Stent for de Novo Lesions in Large Coronary Arteries Guided by Optical Coherence Tomography

NCT04664283 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 254

Last updated 2020-12-11

No results posted yet for this study

Summary

OCT allows precise evaluation of intimal injury after lesion preparation and may improve the acute results and long-term outcomes after paclitaxel drug-coated balloon angioplasty. This prospective multicenter randomized controlled study aims to evaluate the long-term efficacy and safety of paclitaxel coated balloon in the treatment of native large coronary arteries by OCT guided is not inferior to drug-eluting stent.

Conditions

Interventions

DEVICE

DCB for de Novo Lesions in Large Coronary Arteries Guided by Optical Coherence Tomography

DCB for de Novo Lesions in Large Coronary Arteries Guided by both angiogram and Optical Coherence Tomography

Sponsors & Collaborators

  • Liu Bin

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-01-01
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • China

Study Locations

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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 NCT04664283 on ClinicalTrials.gov