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. (part of MicroPort Scientific Corporation) · Not applicable, Interventional, and Treatment
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.
326 studies on the registry are indexed under Coronary Stenosis; 57 are open to participants now.
This study's planned enrollment of 218 is above the median of 190 across 191 interventional studies indexed under Coronary Stenosis.
Browse Coronary Stenosis studies →Shanghai MicroPort Rhythm MedTech Co., Ltd. is the lead sponsor of 8 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Clinical Inclusion Criteria:
Angiographic Inclusion Criteria (visual estimate):
Target lesion stenosis ≥70% (visual estimate), or ≥50% and \<70% with evidence of ischemia. Evidence of ischemia includes any of the following:
Exclusion Criteria:
Clinical Exclusion Criteria:
Angiographic Exclusion Criteria (visual estimate):
Target lesion meets any of the following criteria:
-≥2 target lesions requiring treatment during the baseline procedure
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Coronary Laser Atherectomy System
Device: CVX300 Laser System
The investigational Coronary Laser Atherectomy System consists of two components: (1) a Coronary Laser Console, and (2) Single-use Laser Optical Fiber Catheters.
The control device is the Philips CVX300 Excimer Laser Ablation System, used with single-use ELCA (Excimer Laser Ablation) Catheters.
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
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
Procedural Success Rate
Procedural success is defined as device success in the absence of procedure-related complications.
Time frame: 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.
Time frame: Baseline procedure through 7 days post-procedure
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
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
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
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
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
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
Any Coronary Revascularization Rate
Any coronary revascularization rate
Time frame: 30 days and 6 months post-procedure
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
Death Rate
Death rate (cardiac, vascular, and non-cardiovascular).
Time frame: 30 days and 6 months post-procedure
Myocardial Infarction Rate
Myocardial infarction rate (target vessel-related and non-target vessel-related).
Time frame: 30 days and 6 months post-procedure
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
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
Minimum Lumen Diameter (MLD) (mm)
Minimum lumen diameter (MLD) measured by quantitative coronary angiography (QCA).
Time frame: Baseline procedure
Acute Gain (AG) (mm)
Acute lumen gain (AG) measured by quantitative coronary angiography (QCA).
Time frame: Baseline procedure
Diameter Stenosis (DS) (%)
Diameter stenosis percentage (DS) measured by quantitative coronary angiography (QCA).
Time frame: Baseline procedure
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Jun 2027, 6 months later.
Of 24 industry-sponsored interventional studies with no phase under Coronary Stenosis, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 41. This study's planned 6 months is below that.
Counting every sponsor, half of 71 studies reached it within 26 months; a quarter within 14 and three quarters within 60.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Shanghai MicroPort Rhythm MedTech Co., Ltd. →