Can a laser drill through the Heart's hardest blockages?
NCT ID NCT07743528
First seen Aug 04, 2026 · Last updated Aug 05, 2026 · Updated 1 time
Summary
This trial tests a new device called the Angimis Atherectomy System, which uses laser energy to break up plaque in coronary arteries that are too narrow or hardened for standard balloon or stent procedures. The study enrolls adults with coronary artery disease who have at least one lesion that cannot be crossed or expanded with conventional tools. The main goal is to see if the device can successfully restore blood flow, with follow-up checks for safety and complications over a year.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Angimis Atherectomy System (a device that uses laser energy to remove plaque from coronary arteries)
- What this could lead to
- If successful, this device could offer a new way to open coronary arteries that are too hard or blocked for standard balloon or stent treatment, potentially reducing the need for more invasive surgery.
- What could go wrong
- This is an early-stage, single-arm study without a comparison group, so results may not be definitive. Risks include procedural complications such as vessel perforation, dissection, or stent thrombosis.
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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About 123 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Jul 2028
An estimate. End dates often move.
- 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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19 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: 1. Subjects of age \> 18 years old. 2. Stenosis lesion ≥ 70% diameter stenosis as assessed by visual estimation. 3. Visionally estimated the reference vessel diameter to be ≥ 2.0 mm to allow the passage of guidewire. 4. Subject has at least one non-crossable and/or non-dilatable stenosis lesion. Target lesion belongs to one of the following conditions: 1. Coronary artery lesions previously treated with Drug-Eluting Stent (DES) or Bare-Metal Stent (BMS), including in-stent restenosis or stent under-expansion; or 2. Chronic Total Occlusion (CTO) with an estimated occlusion time of ≥ 3 months and with TIMI flow 0-1 confirmed by Coronary angiography; or 3. De novo coronary lesions with failed balloon angioplasty, defined as residual diameter stenosis \>50% and/or TIMI flow 0-2 after high-pressure balloon inflations, confirmed by coronary angiography. 5. Subject can understand the purpose of the NEON study and has signed voluntarily the informed consent form and is agreeing to the scheduled follow up requirements Exclusion Criteria: 1. Evidence of acute ischemic events 2. Evidence of severe valvular pathology, based on echocardiogram result according to the investigator's assessment. 3. Evidence of \< 30% Left Ventricular Ejection Fraction (LVEF) based on Echocardiogram results 4. Cardiogenic and non-cardiogenic shock within 3 months. 5. Active bleeding or coagulopathy 6. Previous coronary angioplasty within 3 months of the index procedure 7. Patients participating in another trial for which the primary endpoint has not be reached 8. Acute or Chronic renal failure, Impaired renal function (serum creatinine \> 2.5 mg/dl or 221 umol/l) determined within 72 hours prior to index procedure. 9. Known allergies to the following: Aspirin, Clopidogrel or Ticlopidine, Heparin, Sirolimus or its derivatives, contrast agent (that cannot be adequately pre-medicated), or any metal 10. Planned surgery within 6 months of enrolment in this study 11. Life expectancy is less than 6 months 12. Patients known to be suffering from substance abuse (alcohol or drug) 13. Patients with any other significant co-morbid illness which, in the opinion of the investigator, are not conducive to inclusion in the study. 14. Known or suspected Pregnancy and breastfeeding population. Childbearing potential and unwilling to use contraception to control. 15. Patients not willing to provide written informed consent 16. In the investigators' opinion, subjects will not be able to comply with the follow-up requirements. 17. Patients with bifurcation and Ostial lesions
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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