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

NCT07697638 | Not Yet Recruiting

• 1 other identifier: AMD-D-006
• Study Type: interventional
• Target: 218
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Coronary Artery Stenosis

Outcome Measures

Primary Outcomes (1)

• Clinical Success Rate

  Clinical success is defined as target lesion after laser pretreatment, completion of PCI, and coronary angiography confirmed residual stenosis \<30%, TIMI flow grade 3, and no death, myocardial infarction, or target lesion revascularization during the perioperative period (up to 7 days post-procedure).

  Up to 7 days post-procedure

Secondary Outcomes (3)

• Device Success Rate

  Baseline procedure

• Procedural Success Rate

  Baseline procedure

• Procedure-related Complication Rate

  Baseline procedure through 7 days post-procedure

Other Outcomes (12)

• MACE Rate

  30 days and 6 months post-procedure

• Patient-oriented Composite Endpoint (PoCE) Rate

  30 days and 6 months post-procedure

• Target Lesion Failure (TLF) Rate

  30 days and 6 months post-procedure

Study Arms (2)

Coronary Laser Atherectomy System

EXPERIMENTAL

Device: Coronary Laser Atherectomy System

Philips CVX300 Laser Atherectomy System

ACTIVE COMPARATOR

Device: CVX300 Laser System

Interventions

Coronary Laser Atherectomy System DEVICE

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

Coronary Laser Atherectomy System

CVX300 Laser System DEVICE

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

Philips CVX300 Laser Atherectomy System

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-85 years, male or female.
• Coronary angiography confirms the need for PCI.
• Diagnosed with stable angina, silent myocardial ischemia, unstable angina, non-ST-segment elevation myocardial infarction, or STEMI \>7 days.
• During PCI, the investigator determines that laser atherectomy is required for lesion pretreatment.
• Able to understand the purpose of the trial, voluntarily participate and sign the informed consent form acknowledging the risks and benefits described in the informed consent document, and able to complete clinical follow-up as required.
• Target lesion reference vessel diameter (RVD) ≥2.00 mm by visual estimate.
• Target lesion stenosis ≥70% (visual estimate), or ≥50% and \<70% with evidence of ischemia. Evidence of ischemia includes any of the following:
• Positive exercise stress test
• FFR or QFR ≤0.8
• Meets severe stenosis criteria by intracoronary imaging (IVUS or OCT): MLA \<2.4 mm² for vessels with diameter \<3.0 mm; MLA \<2.7 mm² for vessels with diameter 3.0-3.5 mm; MLA \<3.6 mm² for vessels with diameter \>3.5 mm
• Target lesion is a small-diameter predilation balloon (balloon diameter ≤1.5 mm), uncrossable and/or undilatable lesion (undilatable under stent post-dilation balloon rated burst pressure and/or special circumstances unsuitable for dilation), including calcified lesions, CTO lesions, in-stent restenosis, stent underexpansion, and high thrombus burden lesions.
• Guidewire successfully passes through the true lumen of the target lesion without NHLBI type C or higher dissection.

You may not qualify if:

• Hemodynamic instability or severely reduced exercise tolerance (NYHA Class III or IV).
• Severe heart failure with reduced ejection fraction (LVEF \<30%).
• Intracardiac thrombus on echocardiography within 30 days prior to enrollment.
• Has received an organ transplant or is awaiting an organ transplant.
• Currently receiving chemotherapy or scheduled to receive chemotherapy within 30 days before or after the baseline procedure.
• Has a bleeding diathesis, contraindication to antiplatelet or anticoagulant therapy, or is unable to receive antithrombotic therapy.
• Chronic renal insufficiency with serum creatinine \>2.5 mg/dL (or 221 µmol/L).
• Cerebrovascular accident (CVA), transient ischemic attack (TIA), or permanent neurological deficit that may preclude compliance with the protocol within the past 6 months.
• Unconscious or requiring circulatory support or mechanical ventilation before PCI.
• The target vessel (including side branches) has received any PCI within 1 month prior to the baseline procedure.
• Planned interventional or cardiac surgical procedure within 30 days after baseline procedure.
• Prior coronary intravascular brachytherapy at any time.
• Allergy to medications or devices required during PCI (including but not limited to rapamycin, paclitaxel, dual antiplatelet agents, polyamide, polyurethane, PTFE, or stainless steel).
• Other severe medical conditions (e.g., cancer, congestive heart failure) with life expectancy \<12 months.
• Current substance abuse or addiction (e.g., alcohol, cocaine, heroin).

Sponsors & Collaborators

• Shanghai MicroPort Rhythm MedTech Co., Ltd.: lead

MeSH Terms

Conditions

Coronary Stenosis

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Central Study Contacts

Tingting Wu

CONTACT

0086-021-38954600; TingTing.Wu2@microport.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2026
• First Posted: July 13, 2026
• Study Start (Estimated): November 10, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 3, 2027
• Last Updated: July 13, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share