Can a Diamond-Coated rotating crown unclog calcified heart arteries?
NCT ID NCT05447585
First seen Aug 10, 2026 · Last updated Aug 11, 2026 · Updated 1 time
Summary
This trial tests a new atherectomy device that uses a diamond-coated rotating crown to grind away calcium buildup in heart arteries. It aims to see if this device can safely and effectively prepare the artery for stent placement in people with calcified coronary artery disease. The study compares the new device to an existing rotational atherectomy system in about 239 adults aged 18 to 80 who are scheduled for stent implantation.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Coronary atherectomy system (a device with a diamond-coated rotating crown to remove calcium from artery walls)
- What this could lead to
- If successful, this device could offer a safer, more effective way to clear calcified coronary arteries, improving stent placement and reducing heart complications.
- What could go wrong
- This is an early-stage trial, and the device may not outperform existing atherectomy systems. Risks include procedure-related complications like vessel damage or heart events.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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239 people
The number who actually took part.
- Started
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Jul 2022
- Finished
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Aug 2023
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 left ventricular ejection fraction (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 informed consent 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. NYHA 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' platelet \< 50 × 10\^9 / L or \> 700 × 10\^9 / L, and / or hemoglobin \< 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, contraindications of antiplatelet preparation and anticoagulant treatment, and are unable to receive antithrombotic treatment. CE12. History of cerebrovascular accident (CVA), transient ischemic attack (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 hypersensitivity 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 life expectancy 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: * Ostial lesions (within 5mm of ostium); * Target lesions involve bifurcation lesions, and branch vessels need to be implanted with stents; * Angular lesions (\> 45 °) * Located in a native vessel distal to anastomosis with a saphenous vein graft or LIMA/RIMA bypass; * Thrombosis in the target vessel; * Target lesion dissection; * In-stent restenosis; * Chronic total occlusion lesions that cannot be passed through by atherectomy guidewire. 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009, China