Coronary Artery StenosisSHINENCT07697638
Coronary Laser Atherectomy System for Treatment of Coronary Artery Stenosis (SHINE)
A study testing Coronary Laser Atherectomy System and CVX300 Laser System in people with Coronary Artery Stenosis, run by Shanghai MicroPort Rhythm MedTech Co., Ltd..
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Coronary Artery Stenosis
- What is being tested?
- Coronary Laser Atherectomy System and CVX300 Laser System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 218 participants
- Where
- No sites listed yet
- Study dates
- 10 Nov 2026to 3 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical Inclusion Criteria:
- 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.
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- Angiographic Inclusion Criteria (visual estimate):
- 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.
Who cannot join
- Clinical Exclusion Criteria:
- 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.
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- 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).
- 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.
- Plans to conceive within 6 months after baseline procedure.
- Pregnant or breastfeeding women (pregnancy test required within 7 days before baseline procedure for women of childbearing potential).
- The investigator determines that the subject is unsuitable for enrollment.
- Angiographic Exclusion Criteria (visual estimate):
- 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
- Unprotected left main coronary artery disease (>50% diameter stenosis).
- The target vessel has other clinically significant lesions that may require intervention within 6 months after the baseline procedure.
- 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).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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)
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
- Being tested
- Coronary Laser Atherectomy System, CVX300 Laser System
- Medical subject headings
- Coronary Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary Laser Atherectomy SystemDevice
The investigational Coronary Laser Atherectomy System consists of two components: (1) a Coronary Laser Console, and (2) Single-use Laser Optical Fiber Catheters.
CVX300 Laser SystemDevice
The control device is the Philips CVX300 Excimer Laser Ablation System, used with single-use ELCA (Excimer Laser Ablation) Catheters.
| Study group | Role | What they receive |
|---|---|---|
| Coronary Laser Atherectomy System | Experimental | Not described Receives: Device: Coronary Laser Atherectomy System |
| Philips CVX300 Laser Atherectomy System | Active comparator | Not described Receives: Device: CVX300 Laser System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Up to 7 days post-procedure
Secondary outcomes (3)
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.
Measured: Baseline procedure
Procedural Success Rate
Procedural success is defined as device success in the absence of procedure-related complications.
Measured: Baseline procedure
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.
Measured: Baseline procedure through 7 days post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study start10 Nov 2026 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion3 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 218 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai MicroPort Rhythm MedTech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07697638
- Sponsor's protocol ID
- AMD-D-006
- Acronym
- SHINE
- Status last verified
- Jul 2026
- First submitted
- 5 Jul 2026
- Last updated
- 7 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07697638
- Acronym / sponsor ID
- SHINE / AMD-D-006
- Conditions
- Coronary Artery Stenosis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 218 participants (estimated)
- Lead sponsor
- Shanghai MicroPort Rhythm MedTech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Nov 2026 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 3 Dec 2027 (estimated)
- First posted
- 13 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coronary Laser Atherectomy System | Experimental | Device: Coronary Laser Atherectomy System |
| Philips CVX300 Laser Atherectomy System | Active comparator | Device: CVX300 Laser System |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (31 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coronary Laser Atherectomy SystemThe investigational Coronary Laser Atherectomy System consists of two components: (1) a Coronary Laser Console, and (2) Single-use Laser Optical Fiber Catheters. | Device | Coronary Laser Atherectomy System |
| CVX300 Laser SystemThe control device is the Philips CVX300 Excimer Laser Ablation System, used with single-use ELCA (Excimer Laser Ablation) Catheters. | Device | Philips CVX300 Laser Atherectomy System |
Primary outcome
Clinical Success Rate
Time frame: Up to 7 days post-procedure
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).
3 secondary outcomes
Device Success Rate
Time frame: Baseline procedure
Procedural Success Rate
Time frame: Baseline procedure
Procedure-related Complication Rate
Time frame: Baseline procedure through 7 days post-procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Coronary Laser Atherectomy System and CVX300 Laser System in people with Coronary Artery Stenosis, run by Shanghai MicroPort Rhythm MedTech Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tingting Wu (0086-021-38954600, TingTing.Wu2@microport.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Success Rate (time frame: Up to 7 days post-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.