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Intravascular Ultrasound Versus Angiography Guided Drug-coated Balloon

NCT04255043 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 260

Last updated 2024-11-15

No results posted yet for this study

Summary

Drug-coated balloon (DCB) is an alternative choice for denovo lesions in coronary artery disease patients with high bleeding risk. Intravascular ultrasound (IVUS) can provide more details of coronary anatomy and stent implantation, overcoming a number of limitations of coronary angiography. However, the benefit of IVUS-guided DCB treatment has not been investigated. This study is designed to compare IVUS-guided and Angiography-guided DCB treatment for coronary denovo lesions in patients with high bleeding risk.

Conditions

Interventions

DEVICE

IVUS guidance

IVUS (Boston Scientific®) guidance + DCB (Sequent® Please) treatment

DEVICE

Angiography guidance

DCB (Sequent® Please) treatment

Sponsors & Collaborators

  • Nanjing First Hospital, Nanjing Medical University

    lead OTHER

Principal Investigators

  • Shao-Liang Chen, MD · Nanjing First Hospital, Nanjing Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-03
Primary Completion
2023-12-30
Completion
2023-12-30

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 NCT04255043 on ClinicalTrials.gov