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OCT vs IVUS vs QCA to Guide Moderate-to-severe Calcified Lesion Stent Implantation

NCT03574636 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 375

Last updated 2020-01-13

No results posted yet for this study

Summary

This study is a prospective, multi-center, randomized controlled clinical trial, aims to assess the safety and effectiveness of Optical Coherence Tomography or Intravascular Ultrasound or Quantitative Coronary Analysis to guide Firehawk stent implantation , and compared the treatment of moderate-to-severe calcified lesion in coronary artery.

Conditions

  • Optical Coherence Tomography
  • Intravascular Ultrasound
  • Angiography

Interventions

DEVICE

OCT guidance

OCT guide stent implantation

DEVICE

IVUS guidance

IVUS guide stent implantation

DEVICE

QCA

QCA guide stent implantation

Sponsors & Collaborators

  • Shanghai MicroPort Medical (Group) Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Yundai Chen, MD · The General Hospital of People's Liberation Army(301 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
2019-10-18
Primary Completion
2021-09-30
Completion
2025-09-30

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 NCT03574636 on ClinicalTrials.gov