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NOT YET RECRUITING
NCT07697638
NA

Coronary Laser Atherectomy System for Treatment of Coronary Artery Stenosis (SHINE)

Sponsor: Shanghai MicroPort Rhythm MedTech Co., Ltd.

View on ClinicalTrials.gov

Summary

This prospective, multi-center clinical trial evaluates the safety and efficacy of the Coronary Laser Atherectomy System for the pretreatment of coronary artery stenosis. The study consists of two phases: a first-in-human (FIM) phase enrolling 5 subjects in a single center, and a pivotal phase, which is a prospective, multi-center, randomized controlled, non-inferiority trial enrolling 218 subjects across approximately 10 centers in China. Subjects are randomized 1:1 to receive either the investigational laser system or the control Philips CVX300 laser system for lesion pretreatment prior to PCI. The primary endpoint is clinical success, defined as successful PCI with residual stenosis \<30%, TIMI flow grade 3, and no death, myocardial infarction, or target lesion revascularization through 7 days post-procedure. Secondary endpoints include device success, procedural success, MACE, target lesion failure, and target vessel failure at 30 days and 6 months. An OCT sub-study is planned for 40 subjects.

Official title: A Prospective, Multicenter Clinical Trial in Evaluating the Safety and Efficacy of the Coronary Laser Atherectomy System in Patients With Coronary Artery Stenosis (SHINE)

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

218

Start Date

2026-11-10

Completion Date

2027-12-03

Last Updated

2026-07-13

Healthy Volunteers

No

Interventions

DEVICE

Coronary Laser Atherectomy System

The investigational Coronary Laser Atherectomy System consists of two components: (1) a Coronary Laser Console, and (2) Single-use Laser Optical Fiber Catheters.

DEVICE

CVX300 Laser System

The control device is the Philips CVX300 Excimer Laser Ablation System, used with single-use ELCA (Excimer Laser Ablation) Catheters.