A Prospective, Multicenter, Blinded, Randomized Controlled Clinical Trial to Evaluate the Safety and Efficacy of IVUS Console and IVUS Catheter in Coronary Intervention Procedures

Last updated: July 28, 2025
Sponsor: Pulse Medical Imaging Technology (Shanghai) Co., Ltd
Overall Status: Completed

Phase

N/A

Condition

Chest Pain

Atherosclerosis

Coronary Artery Disease

Treatment

IVUS

Clinical Study ID

NCT06974760
BD-IVUS-002
  • Ages > 18
  • All Genders

Study Summary

The goal of this clinical trial is to evaluate the safety and efficacy of IVUS Console and IVUS Catheter in coronary intervention therapy

Participants will:

Undergo IVUS examinations from two different manufacturers(from Pulse and Boston Scientific)

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Subjects aged ≥ 18 years old;

  2. Subjects who require coronary artery intravascular ultrasound (IVUS) guidance priorto stent implantation upon clinical judgment;

  3. Subjects who are able to understand and willing to sign the informed consent form (ICF).

Exclusion

Exclusion Criteria:

  1. Subjects who are not suitable for percutaneous coronary stent implantation;

  2. Subjects who are diagnosed with coronary artery spasm;

  3. Subjects with a history of allergy to contrast agents;

  4. Subjects who are participating in other clinical trials and have not yet reached theprimary endpoint;

  5. Subjects who are deemed ineligible to be included in this trial by the investigator.

Study Design

Total Participants: 150
Treatment Group(s): 1
Primary Treatment: IVUS
Phase:
Study Start date:
July 20, 2023
Estimated Completion Date:
April 17, 2025

Connect with a study center

  • Beijing Anzhen Hospital. Capital Medical University

    Beijing,
    China

    Site Not Available

  • The Sixth Medical Center of PLA General Hospital

    Beijing,
    China

    Site Not Available

  • Shanghai Tongji Hospital

    Shanghai,
    China

    Site Not Available

  • Shanghai Zhongshan Hospital

    Shanghai,
    China

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.