An interventional study of Coronary atherectomy system of Shanghai MicroPort Rhythm and Rotablator Rotational Atherectomy System in Calcification of Coronary Artery, sponsored by Shanghai MicroPort Rhythm MedTech Co., Ltd.. Completed at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-08-10.
Sponsored by Shanghai MicroPort Rhythm MedTech Co., Ltd. (part of MicroPort Scientific Corporation) · Not applicable, Interventional, and Treatment
This is a prospective and multicenter clinical investigation aiming to evaluate the safety and effectiveness of coronary atherectomy system for the treatment of patients with coronary calcification.
This study is divided into two phases. The first phase is the pilot study stage, which is a prospective single group observational test (FIM stage). The second phase is the pivotal study phase, which is a prospective, multicenter, randomized controlled and non inferiority test (RCT phase). It is carried out in about 25 hospitals in China.
91 studies on the registry are indexed under Calcinosis; 19 are open to participants now.
This study's enrollment of 239 is above the median of 70 across 56 interventional studies indexed under Calcinosis.
Browse Calcinosis 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.
Clinical Inclusion Criteria:
CI1. Age between 18 and 80.
CI2. Subjects who are going to accept percutaneous coronary intervention (PCI) and drug-eluting stent implantation.
CI3. Asymptomatic evidence of ischemia, stable or unstable angina pectoris, or old myocardial infarction.
CI4. Acceptable candidates for coronary artery bypass grafting (CABG).
CI5. The (LVEF) is equal to or greater than 30% measured by echocardiography or left ventricle contrast examination within 30 days before inclusion.
CI6. Subjects who are able to understand the purpose of the trial, participate voluntarily or by proxy and indicate by signing the form that they recognize the risks and benefits described in the informed consent document and are willing to undergo clinical follow-up.
Angiography Inclusion Criteria:
AI1. There is only one target lesion that needs to be treated.
AI2. The target vessel must be a native coronary artery with reference diameter >= 2.5mm and \<= 4.0 mm.
AI3. The target vessel must be with a stenosis of >= 70% and \< 100%Target lesion angiographic stenosis, or of >=50% and \<70% with local ischemic symptoms.
AI4. Target lesion length ≤ 40 mm .
AI5. The target lesion must have evidence of severe calcium deposit, or moderate calcification which cannot be fully expanded by PTCA balloon catheter at the lesion site based on the protocol criterion, .
Clinical Exclusion Criteria:
CE1. Acute myocardial infarction within 30 days prior to baseline procedure.
CE2. or Killip class III or IV heart failure.
CE3. Severe cardiac insufficiency with reduced ejection fraction (left ventricular ejection fraction \< 30%).
CE4. Intracardiac thrombus within 30 days before inclusion.
CE5. Subjects who have received organ transplantation or is waiting for organ transplantation.
CE6. Subjects who are receiving chemotherapy or scheduled to receive chemotherapy 30 days before or after baseline surgery.
CE7. Subjects who are receiving chronic (≥ 72 hours) anticoagulant therapy (e.g. heparin, warfarin, coumarin) for indications other than acute coronary syndrome.
CE8. Participants' \< 50 × 10\^9 / L or > 700 × 10\^9 / L, and / or \< 70g / L.
CE9. Subjects with confirmed or suspected liver diseases, including active hepatitis, or abnormal laboratory results are not suitable for the study.
CE10. Subjects diagnosed with chronic renal failure or has a serum creatinine level >2.5 mg/dl (or 221 µmol / L).
CE11. Subjects who have clear bleeding tendency, of antiplatelet preparation and anticoagulant treatment, and are unable to receive antithrombotic treatment.
CE12. History of cerebrovascular accident (CVA), (TIA), active peptic ulcer disease, gastrointestinal (GI) bleeding, transient ischemic attack (TIA), or permanent neurological defects that may lead to non-compliance with the test protocol in the past 6 months.
CE13. Target vessels (including collateral vessels) received any stent implantation within 12 months before baseline surgery.
CE14. Non target vessels were treated with any type of PCI within 24 hours before baseline surgery.
CE15. PCI or CABG is planned within 2 months after baseline procedure.
CE16. History of coronary endovascular brachytherapy at any time.
CE17. Known to any drugs required by the stent or protocol (such as rapamycin or structure related compounds, fluoropolymers, aspirin or tigrelol, contrast medium, acrylic acid, stainless steel, chromium, nickel, iron, tungsten).
CE18. Subjects who have other serious medical diseases (such as cancer, congestive heart failure), which may reduce to less than 12 months or it is expected to be difficult to complete 12-months follow-up.
CE19. Subjects who currently abuse drugs, such as heroin, alcohol, etc.
CE20. Subjects who plan to undergo surgery that may lead to non-compliance with the protocol or confusion in data interpretation.
CE21. Currently enrolled in any other clinical trial (does not reach its primary endpoint), or intended to participate in any other clinical trial within 12 months after baseline procedure.
CE22. Females subjects who are pregnant,breast feeding or planning to become pregnant within the study period.
CE23. Untrolled diabetes.
CE24. Inability to understand the study or a history of non-compliance with medical advice.
Angiographic Exclusion Criteria:
AE1. Target lesions that meet the following criteria:
AE2. Unprotected left main coronary artery disease (> 50% diameter stenosis).
AE3. Protected left main coronary artery disease (> 50% diameter stenosis at LMCA and left coronary artery receive bypass grafting), and the target lesion is located in LAD or LCX.
AE4. Other clinical significant lesions in target vessels may require intervention within 2 months after baseline surgery.
AE5. The target vessel (including collateral) near the target lesion or within 10 mm (visually) from the distal end of the target lesion has received stent implantation at any time before baseline surgery.
AE6. Especially tortuous target vessels. AE7. Non-target lesion failed to be treated before the treatment of target lesion.
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.
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.
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.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
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.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
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.
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.
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.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
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.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
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.
Subjects in experimental arm will be treated with the Coronary Atherectomy System manufactured by Shanghai Microport Rhythm Co. Ltd.
Device: Coronary atherectomy system of Shanghai MicroPort Rhythm
Subjects in control arm will be treated with Rotablator Rotational Atherectomy System manufactured by Boston Scientific Corporation
Device: Rotablator Rotational Atherectomy System
Coronary Atherectomy System utilizes a diamond-coated eccentric crown to expand the lumen diameter via centrifugal forces while rotating over an atherectomy guide wire.
Also known as: Stenting will be applied in both arms
The Rotablator Rotational Atherectomy System is comprised of a Rotablator RotaGlide, a Rotablator RotaLink Plus/RotaWire/Console
Also known as: Stenting will be applied in both arms
FIM phase: Clinical success
Clinical success is defined as successful stent delivery with a residual stenosis of \<50% and TIMI flow III without adverse events during procedure the occurrence of an in-hospital MACE (up to 7 days after surgery).
Time frame: During hospitalization (up to 7 days after baseline procedure).
RCT phase: 30-Day Freedom From Major Adverse Cardiac Events (MACE)
MACE is composed of cardiac death, myocardial infarction and target vessel revascularization.
Time frame: 30 days after baseline procedure.
Device success
Device success is defined as successful stent delivery after atherectomy and without periprocedural complications
Time frame: Baseline procedure
Procedural success
Procedural success was defined as successful stent delivery with \<50% residual stenosis and TIMI flow III and without periprocedural complications
Time frame: Baseline procedure
Procedure-related complications
Procedure-related complications are defined as severe dissection (Type D to F), perforation, stent upload and in-stent thrombosis.
Time frame: Baseline procedure
Ran from Jul 2022 to primary completion in Aug 2023, 13 months.
Of 19 interventional studies with no phase under Calcinosis, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 47. This study's 13 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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