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Not yet recruitingNCT07697638SHINEUpdated Aug 7, 2026

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

An interventional study of Coronary Laser Atherectomy System and CVX300 Laser System in Coronary Artery Stenosis, sponsored by Shanghai MicroPort Rhythm MedTech Co., Ltd.. Not yet recruiting. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-08-07.

Sponsored by Shanghai MicroPort Rhythm MedTech Co., Ltd. · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
218
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Coronary Artery Stenosis

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03

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

Clinical Inclusion Criteria:

  1. Age 18-85 years, male or female.
  2. Coronary angiography confirms the need for PCI.
  3. Diagnosed with stable angina, silent myocardial ischemia, unstable angina, non-ST-segment elevation myocardial infarction, or STEMI >7 days.
  4. During PCI, the investigator determines that laser atherectomy is required for lesion pretreatment.
  5. 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.

Angiographic Inclusion Criteria (visual estimate):

  1. Target lesion reference vessel diameter (RVD) ≥2.00 mm by visual estimate.

  2. 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
  3. 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.
  4. Guidewire successfully passes through the true lumen of the target lesion without NHLBI type C or higher dissection.

Exclusion criteria

Exclusion Criteria:

Clinical Exclusion Criteria:

  1. Hemodynamic instability or severely reduced exercise tolerance (NYHA Class III or IV).
  2. Severe heart failure with reduced ejection fraction (LVEF \<30%).
  3. Intracardiac thrombus on echocardiography within 30 days prior to enrollment.
  4. Has received an organ transplant or is awaiting an organ transplant.
  5. Currently receiving chemotherapy or scheduled to receive chemotherapy within 30 days before or after the baseline procedure.
  6. Has a bleeding diathesis, contraindication to antiplatelet or anticoagulant therapy, or is unable to receive antithrombotic therapy.
  7. Chronic renal insufficiency with serum creatinine >2.5 mg/dL (or 221 µmol/L).
  8. Cerebrovascular accident (CVA), transient ischemic attack (TIA), or permanent neurological deficit that may preclude compliance with the protocol within the past 6 months.
  9. Unconscious or requiring circulatory support or mechanical ventilation before PCI.
  10. The target vessel (including side branches) has received any PCI within 1 month prior to the baseline procedure.
  11. Planned interventional or cardiac surgical procedure within 30 days after baseline procedure.
  12. Prior coronary intravascular brachytherapy at any time.
  13. Allergy to medications or devices required during PCI (including but not limited to rapamycin, paclitaxel, dual antiplatelet agents, polyamide, polyurethane, PTFE, or stainless steel).
  14. Other severe medical conditions (e.g., cancer, congestive heart failure) with life expectancy \<12 months.
  15. Current substance abuse or addiction (e.g., alcohol, cocaine, heroin).
  16. Currently participating in another investigational drug or device trial that has not reached its primary endpoint, or planning to participate in another investigational drug or device trial within 6 months after the baseline procedure.
  17. Plans to conceive within 6 months after baseline procedure.
  18. Pregnant or breastfeeding women (pregnancy test required within 7 days before baseline procedure for women of childbearing potential).
  19. The investigator determines that the subject is unsuitable for enrollment.

Angiographic Exclusion Criteria (visual estimate):

  1. Target lesion meets any of the following criteria:

    -≥2 target lesions requiring treatment during the baseline procedure

    • Ostial lesion (within 3 mm of the ostium)
    • Medina type "x, x, 1" bifurcation lesion
    • Intimal dissection (NHLBI type C or higher)
    • Guidewire-uncrossable total occlusion
    • Severely angulated lesion
  2. Unprotected left main coronary artery disease (>50% diameter stenosis).
  3. The target vessel has other clinically significant lesions that may require intervention within 6 months after the baseline procedure.
  4. Predicted inability to deliver the laser fiber catheter to the target lesion due to various reasons (e.g., severe proximal tortuosity of the target vessel).
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
218 participants (estimated)

Study arms

  • Experimental
    Coronary Laser Atherectomy System

    Device: Coronary Laser Atherectomy System

  • Active comparator
    Philips CVX300 Laser Atherectomy System

    Device: CVX300 Laser System

Interventions

  • DeviceCoronary 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.

  • DeviceCVX300 Laser System

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

05

What researchers measure

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).

    Time frame: Up to 7 days post-procedure

Secondary outcomes

  1. Device Success Rate

    Device success is defined as a target lesion after laser pretreatment, completion of PCI, and coronary angiography confirmed residual stenosis \<30%, TIMI flow grade 3.

    Time frame: Baseline procedure

  2. Procedural Success Rate

    Procedural success is defined as device success in the absence of procedure-related complications.

    Time frame: Baseline procedure

  3. Procedure-related Complication Rate

    Procedure-related complications is defined as stroke, vessel perforation or rupture requiring treatment, NHLBI type C or higher dissection, thrombosis requiring revascularization, and no-reflow.

    Time frame: Baseline procedure through 7 days post-procedure

Other outcomes

  1. MACE Rate

    MACE is defined as cardiac death, non-fatal myocardial infarction, and target vessel revascularization.

    Time frame: 30 days and 6 months post-procedure

  2. Patient-oriented Composite Endpoint (PoCE) Rate

    PoCE is defined as all-cause death, stroke, all myocardial infarction, and any revascularization.

    Time frame: 30 days and 6 months post-procedure

  3. Target Lesion Failure (TLF) Rate

    TLF is defined as cardiac death, target vessel-related myocardial infarction, and clinically driven target lesion revascularization.

    Time frame: 30 days and 6 months post-procedure

  4. Target Vessel Failure (TVF) Rate

    TVF is defined as cardiac death, target vessel-related myocardial infarction, and clinically-driven target vessel revascularization.

    Time frame: 30 days and 6 months post-procedure

  5. Target Lesion Revascularization (TLR) Rate

    TLR is defined as repeat percutaneous intervention or bypass surgery of the target lesion due to restenosis or other complications.

    Time frame: 30 days and 6 months post-procedure

  6. Target Vessel Revascularization (TVR) Rate

    TVR is defined as repeat percutaneous intervention or bypass surgery of any segment of the target vessel.

    Time frame: 30 days and 6 months post-procedure

  7. Any Coronary Revascularization Rate

    Any coronary revascularization rate

    Time frame: 30 days and 6 months post-procedure

  8. ARC-defined Thrombosis Rate

    ARC-defined thrombosis rate, including acute, subacute, late, and very late definite, probable, and possible stent thrombosis.

    Time frame: 30 days and 6 months post-procedure

  9. Death Rate

    Death rate (cardiac, vascular, and non-cardiovascular).

    Time frame: 30 days and 6 months post-procedure

  10. Myocardial Infarction Rate

    Myocardial infarction rate (target vessel-related and non-target vessel-related).

    Time frame: 30 days and 6 months post-procedure

  11. Optical Coherence Tomography (OCT) Endpoints - After Laser Pretreatment (OCT Substudy)

    Includes minimum lumen area (mm²), minimum lumen diameter (mm), and lumen area stenosis percentage (%) measured after laser pretreatment and before stent implantation or drug-coated balloon dilation. Each endpoint will be reported separately.

    Time frame: Baseline procedure

  12. Optical Coherence Tomography (OCT) Endpoints - At PCI Completion (OCT Substudy)

    Includes minimum stent area (mm²), mean stent area (mm²), minimum stent diameter (mm), mean stent diameter (mm), minimum lumen area (mm²), minimum lumen diameter (mm), mean reference lumen area (mm²), lumen area stenosis percentage (%), acute lumen gain (mm²), stent expansion index (%), and stent strut malapposition rate (%). Stent-related endpoints are not measured in subjects without stent implantation. Each endpoint will be reported separately.

    Time frame: Baseline procedure

  13. Minimum Lumen Diameter (MLD) (mm)

    Minimum lumen diameter (MLD) measured by quantitative coronary angiography (QCA).

    Time frame: Baseline procedure

  14. Acute Gain (AG) (mm)

    Acute lumen gain (AG) measured by quantitative coronary angiography (QCA).

    Time frame: Baseline procedure

  15. Diameter Stenosis (DS) (%)

    Diameter stenosis percentage (DS) measured by quantitative coronary angiography (QCA).

    Time frame: Baseline procedure

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07697638
Lead sponsor
Shanghai MicroPort Rhythm MedTech Co., Ltd.
Responsible party
Sponsor
First posted
Jul 13, 2026
Start date
Nov 10, 2026 (estimated)
Primary completion
Jun 1, 2027 (estimated)
Completion
Dec 3, 2027 (estimated)
Last update
Aug 7, 2026

Study contacts

Tingting Wu
Contact
TingTing.Wu2@microport.com
0086-021-38954600

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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