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

NCT06974760 | Completed DMC

• 1 other identifier: BD-IVUS-002
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 4

Brief 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）

Conditions

Percutaneous Coronary Intervention (PCI); Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Effectiveness

  Measure the Mean Stent Area in square millimeter(MSA) Comparison between the MSA measured by the Pulse and Boston Scientific Intravascular Ultrasound Diagnostic System, including mean relative deviation, confidence interval and standard deviation, as assessed by Bland-Altman analysis .

  From enrollment to the end of treatment at one week

Secondary Outcomes (6)

• Minimal Lumen Area in square millimeter(MLA)

  Estimated 1 month on average, by a third-party corelab IVUS image post-analysis

• Stent Length in millimeter (SL)

  Estimated 1 month on average, by a third-party corelab IVUS image post-analysis

• The rate of detected stent malapposition, tissue prolapse and dissection

  Estimated 1 month on average, by a third-party corelab IVUS image post-analysis

• Identification plaque properties

  Estimated 1 month on average, by a third-party corelab IVUS image post-analysis

• Stability of system(questionnaire)

  estimated 1week on average, by opeartor's rating on questionaire

Other Outcomes (2)

• Rate of intraoperative adverse effects

  From enrollment to the end of treatment at one weeks

• Rate of successful use of instruments

  From enrollment to the end of treatment at one weeks

Study Arms (2)

Boston IVUS

OTHER

Device: IVUS

Pluse IVUS

OTHER

Device: IVUS

Interventions

IVUS DEVICE

The Participants will receive IVUS examinations from Pulse and Boston

Boston IVUS; Pluse IVUS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects aged ≥ 18 years old;
• Subjects who require coronary artery intravascular ultrasound (IVUS) guidance prior to stent implantation upon clinical judgment;
• Subjects who are able to understand and willing to sign the informed consent form (ICF).

You may not qualify if:

• Subjects who are not suitable for percutaneous coronary stent implantation;
• Subjects who are diagnosed with coronary artery spasm;
• Subjects with a history of allergy to contrast agents;
• Subjects who are participating in other clinical trials and have not yet reached the primary endpoint;
• Subjects who are deemed ineligible to be included in this trial by the investigator.

Sponsors & Collaborators

• Pulse Medical Imaging Technology (Shanghai) Co., Ltd: lead

Study Sites (4)

Beijing Anzhen Hospital. Capital Medical University

Beijing, China

Location

The Sixth Medical Center of PLA General Hospital

Beijing, China

Location

Shanghai Tongji Hospital

Shanghai, China

Location

Shanghai Zhongshan Hospital

Shanghai, China

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2025
• First Posted: May 16, 2025
• Study Start: July 20, 2023
• Primary Completion: April 17, 2025
• Study Completion: April 17, 2025
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)