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

Pulse Medical Imaging Technology (Shanghai) Co., Ltd150 enrolled

Overview

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）

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

150

Conditions

Percutaneous Coronary Intervention (PCI)Coronary Artery Disease

Interventions

IVUSDEVICE

The Participants will receive IVUS examinations from Pulse and Boston

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Subjects aged ≥ 18 years old; 2. Subjects who require coronary artery intravascular ultrasound (IVUS) guidance prior to stent implantation upon clinical judgment; 3. Subjects who are able to understand and willing to sign the informed consent form (ICF). 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 the primary endpoint; 5. Subjects who are deemed ineligible to be included in this trial by the investigator.

Locations (4)

Beijing Anzhen Hospital. Capital Medical University

Beijing, China

The Sixth Medical Center of PLA General Hospital

Beijing, China

Shanghai Tongji Hospital

Shanghai, China

Shanghai Zhongshan Hospital

Shanghai, China

Outcomes

Primary Outcomes

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 .

Time frame: From enrollment to the end of treatment at one week

Secondary Outcomes

Minimal Lumen Area in square millimeter(MLA)

Comparison between the MLA measured by the Pubmed Intravascular Ultrasound Diagnostic System and Boston Scientific Intravascular Ultrasound Diagnostic System, as assessed by Bland-Altman analysis and Pearson analysis.

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

Stent Length in millimeter (SL)

Comparison between the SL measured by the Pubmed Intravascular Ultrasound Diagnostic System and Boston Scientific Intravascular Ultrasound Diagnostic System, as assessed by Bland-Altman analysis and Pearson analysis.

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

The rate of detected stent malapposition, tissue prolapse and dissection

Detection rate of poor adherence, tissue prolapse and intercalation, for each system individually, and comparison between the two systems.

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

Identification plaque properties

Rates of lipid-rich plaque, fibrous plaque and calcified plaque, discerned by each system individually, and comparison between the two systems

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

Data from ClinicalTrials.gov

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