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

Status: Completed

Conditions: Coronary Artery Disease; Percutaneous Coronary Intervention (PCI)

Treatments: Device: IVUS

Study type: Interventional

Funder types: Industry

Identifiers

NCT06974760

BD-IVUS-002

Details and patient eligibility

About

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）

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 2 patient groups

Boston IVUS

Other group

Treatment:

Device: IVUS

Pluse IVUS

Other group

Treatment:

Device: IVUS