Can a vibrating wire reopen completely blocked heart arteries?
NCT ID NCT05813704
First seen Aug 10, 2026 · Last updated Aug 11, 2026 · Updated 1 time
Summary
This trial tests a new device designed to help doctors reopen coronary arteries that are completely blocked, a condition called chronic total occlusion. The device makes the tip of a guidewire vibrate at high frequency, which may help it safely cross the tough, fibrous cap of the blockage. The study will enroll about 159 adults with symptoms of angina and evidence of reduced blood flow to the heart. The main goal is to see if the device can successfully cross the blockage and restore blood flow, while also checking its safety.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Coronary Crossing System, a device that vibrates the tip of a guidewire to penetrate blocked coronary arteries
- What this could lead to
- If successful, this device could offer a new way to reopen completely blocked heart arteries, potentially improving blood flow and reducing symptoms in patients who are hard to treat.
- What could go wrong
- This is an early-stage trial with a modest number of participants. The device may not always cross the blockage, and there are risks of complications like vessel damage or heart rhythm issues.
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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159 people
The number who actually took part.
- Started
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Nov 2023
- Finished
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Aug 2024
- 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 years and older
- 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.
Inclusion Criteria: Clinical Inclusion Criteria: 1. Aged 18 years and older. 2. Subjects with coronary artery disease who have symptoms of angina pectoris and evidence of ischemia or myocardial viability in the area innervated by the coronary arteries where the CTO is located. 3. 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: 1. There is only one target CTO that needs to be treated with percutaneous coronary intervention (PCI). 2. Target CTO is located in a native coronary artery with a reference vessel diameter of ≥ 2.5 mm. 3. Angiography showed complete occlusion of the target CTO (visual inspection), antegrade flow of the occluded vessel segment TIMI grade 0 and inferred occlusion time ≥ 3 months; or previous angiographic records confirmed occluded time of the target CTO ≥ 3 months. 4. The target CTO occluded segment length ≥ 5 mm (visual inspection). 5. Angiography of the target CTO showed high density along the vessel, which is considered calcified lesion. 6. The antegrade approach is determined as the primary strategy with guidewire crossing in PCI treatment. 7. The fibrous cap of the target lesion can not be penetrated within 60 seconds using the guidewire with polypolymer coated or tip stiffness \> 1.5g (visual inspection) under fluoroscopy and the time is timed when the guidewire reaches the fibrous cap. (To identify chronic total occlusions and exclude acute or subacute occlusions that such guidewire can pass directly). 8. In addition to the target lesion, there must be up to one non-target lesion to be treated and it is located on a different epicardial vessel than the target lesion. Target lesions can be treated after successful treatment of the non-target lesion (residual stenosis \< 30% and TIMI 3 flow) without complications. Exclusion Criteria: General Exclusion Criteria: 1. Acute myocardial infarction within 30 days prior to baseline procedure. 2. Life expectancy \< 1 year. 3. Inability to use protocol-required concomitant medications (eg, aspirin, P2Y12 platelet receptor inhibitors, heparin, contrast agents, etc) due to allergy or other contraindications, and no alternative medications. 4. The target CTO has an iatrogenic dissection that occurred within the past 3 months. 5. Left ventricular ejection fraction less than 35%. 6. Severe aortic or mitral valve disease. 7. Planned left ventricular (LV) support device during CTO PCI. 8. Subjects with clear bleeding tendency, contraindications to antiplatelet agents and anticoagulant therapy. 9. Stroke, transient ischemic attack (TIA), or significant gastrointestinal (GI) bleeding within 6 months before the baseline procedure. 10. Planned additional coronary or valvular percutaneous or surgical intervention scheduled within 30 days after baseline procedure. 11. Subjects who require emergent or urgent PCI. 12. Female subjects who are pregnant or breast-feeding. 13. Subjects who are participating in another investigational drug or device clinical trial in which the primary endpoint is still not reached, or intend to participate in another investigational drug or device clinical trial within 12 months after baseline procedure. 14. Other medical illnesses that may cause the subject to be non-compliant with the protocol or confound data interpretation. 15. Serum creatinine \> 2.5 mg/dL (or 221 µmol/L), or on dialysis. 16. Hemodynamic instability or severely impaired activity tolerance (KILLIP Class III, IV, or NYHA Class III, IV). 17. Subjects with sustained tachyarrhythmia or cardiogenic shock. Angiography Exclusion Criteria: 1. The target CTO is in an unprotected left main. 2. No angiographically visible collateral flow to the target vessel distal to the occlusion, from ipsilateral or contralateral collaterals. 3. Because of the presence of moderate to severe tortuosity or stenosis in the collateral vessels, retrograde approach is not preferred at the investigator 's discretion. 4. Vessel tortuosity proximal to, or within, body of target occlusion which, in the opinion of the investigator, is not amenable to advancement of a microcatheter or Coronary Crossing System.
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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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Zhongshan Hospital of Fudan University
Shanghai, China
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