Angimis Atherectomy System is Indicated for CTO, Balloon Failure and ISR in Coronary Arteries DiseaseNEONNCT07743528
A Prospective, Multicenter, Two-cohorts, Single Arm Study Evaluating Safety, Effectiveness and Performance of Angimis Atherectomy System for the Treatment of Non-crossable and/or Non-dilatablE Lesions in CorONary Arteries Disease (NEON Study).
A study testing Adult patient population who have been diagnosed with coronary artery disease with non-crossable and/or non-dilatable lesion which requiring the treatment of PCI in people with Angimis Atherectomy System is Indicated for CTO, Balloon Failure and ISR in Coronary Arteries Disease, run by Shenzhen Tonglu Technology Co., Ltd.
Trial summary
NEON study is a prospective, multicenter, two-cohorts, single arm study evaluating safety, effectiveness and performance of Angimis Atherectomy System for the treatment of Non-crossable and/or Non-dilatable in Coronary Arteries Disease. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Angimis Atherectomy System is Indicated for CTO, Balloon Failure and ISR in Coronary Arteries Disease
- What is being tested?
- Adult patient population who have been diagnosed with coronary artery disease with non-crossable and/or non-dilatable lesion which requiring the treatment of PCI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2026to 15 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects of age > 18 years old.
- Stenosis lesion ≥ 70% diameter stenosis as assessed by visual estimation.
- Visionally estimated the reference vessel diameter to be ≥ 2.0 mm to allow the passage of guidewire.
- Subject has at least one non-crossable and/or non-dilatable stenosis lesion. Target lesion belongs to one of the following conditions:
- Coronary artery lesions previously treated with Drug-Eluting Stent (DES) or Bare-Metal Stent (BMS), including in-stent restenosis or stent under-expansion; or
- Chronic Total Occlusion (CTO) with an estimated occlusion time of ≥ 3 months and with TIMI flow 0-1 confirmed by Coronary angiography; or
- 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.
- 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
Who cannot join
- Evidence of acute ischemic events
- Evidence of severe valvular pathology, based on echocardiogram result according to the investigator's assessment.
- Evidence of < 30% Left Ventricular Ejection Fraction (LVEF) based on Echocardiogram results
- Cardiogenic and non-cardiogenic shock within 3 months.
- Active bleeding or coagulopathy
- Previous coronary angioplasty within 3 months of the index procedure
Show all 17Show fewer
- Patients participating in another trial for which the primary endpoint has not be reached
- 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.
- 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
- Planned surgery within 6 months of enrolment in this study
- Life expectancy is less than 6 months
- Patients known to be suffering from substance abuse (alcohol or drug)
- Patients with any other significant co-morbid illness which, in the opinion of the investigator, are not conducive to inclusion in the study.
- Known or suspected Pregnancy and breastfeeding population. Childbearing potential and unwilling to use contraception to control.
- Patients not willing to provide written informed consent
- In the investigators' opinion, subjects will not be able to comply with the follow-up requirements.
- Patients with bifurcation and Ostial lesions
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Prospective, Multicentre, Two-cohorts Single-arm Clinical Investigation Evaluating Safety, Effectiveness and Performance of Angimis Atherectomy System for the Treatment of Non-crossable and/or Non-dilatablE Lesions in CorONary Arteries Disease (NEON Study).
NEON study is a prospective, multicenter, two-cohorts, single arm study evaluating safety, effectiveness and performance of Angimis Atherectomy System for the treatment of Non-crossable and/or Non-dilatable in Coronary Arteries Disease. The primary endpoint assesses the effectiveness of the Angimis Atherectomy System by evaluating its angiographic success defined as final TIMI flow grade 3 with residual stenosis ≤30% on quantitative coronary angiography after the procedure of balloon and/or stent implementation validated by an independent, centralized core laboratory. The secondary safety endpoint assesses the rate of major complications before discharge, procedural success is defined as angiographic success without severe procedural complications (death, perforation, flow limiting dissection, acute vessel closure, or stent thrombosis) after the procedure, and clinical success defined as procedural success without complications during admission: cardiovascular death, target lesion revascularization, probable or definite stent thrombosis, stroke, and Bleeding Academic Research Consortium grade 3b or higher bleeding at 3, 6 and 12 months after the procedure. The secondary performance endpoint assesses the device technical success defined as successful preparation, delivery and use of the investigational device according to the IFU, including delivery of the laser catheter to the intended treatment location, successful delivery of laser energy, completion of the intended laser treatment without device malfunction, and retrieval of the device without device-related failure. Llaser success defined as successful lesion modification attributable to the investigational device, demonstrated by either a) successful advancement of the laser catheter across the target lesion with effective laser-mediated plaque ablation, or b) effective plaque ablation produced by laser energy delivered proximal to the lesion, enabling subsequent balloon crossing and lesion expansion that would otherwise not have been achievable.
Read the detailed description
This NEON study is a prospective, multicentre, two cohort, open-label non-comparative study, conducted up to 5 clinical sites in Europe and Asia.
The primary objective of the NEON study is to generate clinical evidence demonstrating the safety and clinical performance of the Angimis Atherectomy System in subjects with non-dilatable and non-crossable coronary lesions, in support of the MDR conformity assessment. The primary endpoint will be evaluated against a predefined Performance Goal derived from historical clinical evidence using a non-inferiority statistical framework.
In addition, only for the non-dilatable cohort, a pilot phase (6 patients) will be conducted to evaluate the safety of Angimis Atherectomy System by assessing the Rate of major complications before discharge. The pivotal phase will commence after the initial safety profile is confirmed from the pilot phase. For the uncrossable lesion, there is only the pivotal phase as part of this clinical investigation.
Primary endpoint:
The primary effectiveness endpoint will assess the proportion of treated subjects in whom angiographic success was achieved. Angiographic success is defined as final TIMI flow grade 3 with residual stenosis ≤30% on quantitative coronary angiography after the procedure of balloon or stent implementation validated by an independent, centralized core laboratory.
A maximum of two target lesions may be treated with the investigational device during the index procedure. Where two target lesions are treated, one lesion shall be prospectively designated by the investigator, prior to treatment, as the Primary Target Lesion. The primary effectiveness endpoint will be assessed exclusively on the Primary Target Lesion. One additional Target Lesion may be treated during the same procedure when clinically indicated; data related to this lesion will be collected separately and included in secondary performance and safety analyses. Treatment of more than two Angimis-treated target lesions during the same index procedure is not planned in this clinical investigation.
Secondary endpoint:
- Safety:
- Rate of major complications before discharge as predefined previously 2) This endpoint will be assessed immediately after the procedure and will determine the number of patients in whom procedural success was achieved.
- This endpoint will be evaluated at 3, 6, and 12 months after the procedure and will measure the proportion of treated subjects in whom clinical success was achieved 2. Performance:
- Device Technical Success, defined as successful preparation, delivery, and use of the investigational device according to the IFU, including delivery of the laser catheter to the intended treatment location, successful delivery of laser energy, completion of the intended laser treatment without device malfunction, and retrieval of the device without device-related failure.
- Laser Success, defined as successful lesion modification attributable to the investigational device, demonstrated by either:
- successful advancement of the laser catheter across the target lesion with effective laser-mediated plaque ablation; or
- effective plaque ablation produced by laser energy delivered proximal to the lesion, enabling subsequent balloon crossing and lesion expansion that would otherwise not have been achievable The secondary performance endpoint will evaluate the laser success rate during the procedure.
- User handling:
User handling will be assessed during the procedure based on the following points:
- Pushability of the catheter,
- Crossability of the catheter,
- Retrievability of the catheter,
- readability of the system interface.
- Operability of the system
User handling procedures will ensure standardized and consistent data collection across all participating sites in different countries. Investigators and site users will be trained to record procedural details precisely, including the catheter diameter used, angiographic findings, and post-procedural assessments.
Specific instructions will be provided to ensure consistent evaluation and documentation of these performance characteristics across users and regions. Data entry interfaces will be configured to minimize variability between users and centres, with controlled terminology and predefined ranges to ensure homogeneity of reporting.
- Being tested
- Adult patient population who have been diagnosed with coronary artery disease with non-crossable and/or non-dilatable lesion which requiring the treatment of PCI
- Keywords
- NEON
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adult patient population who have been diagnosed with coronary artery disease with non-crossable and/or non-dilatable lesion which requiring the treatment of PCIDevice
The device is intended for the non-crossable and/or non-dilatable lesions during PCI.
| Study group | Role | What they receive |
|---|---|---|
| All eligible subjects will be treated by the investigational device. | Experimental | Not described Receives: Device: Adult patient population who have been diagnosed with coronary artery disease with non-crossable and/or non-dilatable lesion which requiring the treatment of PCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary effectiveness endpoint will assess the proportion of treated subjects in whom angiographic success was achieved.
Angiographic success is defined as final TIMI flow grade 3 with residual stenosis ≤30% on quantitative coronary angiography after the procedure of balloon or stent implementation validated by an independent, centralized core laboratory
Measured: Immediate after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study start15 Sep 2026 (estimated)
- Primary completion15 May 2027 (estimated)
- Study completion15 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Angimis Atherectomy System is Indicated for CTO, Balloon Failure and ISR in Coronary Arteries DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 123 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Tonglu Technology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ospedale San'Anna, University of Rome Tor Vergata, Siloam Hospitals Lippo Village
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07743528
- Sponsor's protocol ID
- NEON-2026
- Acronym
- NEON
- Status last verified
- Jul 2026
- First submitted
- 30 Jul 2026
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicentre, Two-cohorts Single-arm Clinical Investigation Evaluating Safety, Effectiveness and Performance of Angimis Atherectomy System for the Treatment of Non-crossable and/or Non-dilatablE Lesions in CorONary Arteries Disease (NEON Study).
- ClinicalTrials.gov ID
- NCT07743528
- Acronym / sponsor ID
- NEON / NEON-2026
- Keywords
- NEON
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 123 participants (estimated)
- Lead sponsor
- Shenzhen Tonglu Technology Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Ospedale San'Anna, University of Rome Tor Vergata, Siloam Hospitals Lippo Village
- Study start
- 15 Sep 2026 (estimated)
- Primary completion
- 15 May 2027 (estimated)
- Study completion
- 15 Jul 2028 (estimated)
- First posted
- 4 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
NEON study is a prospective, multicenter, two-cohorts, single arm study evaluating safety, effectiveness and performance of Angimis Atherectomy System for the treatment of Non-crossable and/or Non-dilatable in Coronary Arteries Disease. The primary endpoint assesses the effectiveness of the Angimis Atherectomy System by evaluating its angiographic success defined as final TIMI flow grade 3 with residual stenosis ≤30% on quantitative coronary angiography after the procedure of balloon and/or stent implementation validated by an independent, centralized core laboratory. The secondary safety endpoint assesses the rate of major complications before discharge, procedural success is defined as angiographic success without severe procedural complications (death, perforation, flow limiting dissection, acute vessel closure, or stent thrombosis) after the procedure, and clinical success defined as procedural success without complications during admission: cardiovascular death, target lesion revascularization, probable or definite stent thrombosis, stroke, and Bleeding Academic Research Consortium grade 3b or higher bleeding at 3, 6 and 12 months after the procedure. The secondary performance endpoint assesses the device technical success defined as successful preparation, delivery and use of the investigational device according to the IFU, including delivery of the laser catheter to the intended treatment location, successful delivery of laser energy, completion of the intended laser treatment without device malfunction, and retrieval of the device without device-related failure. Llaser success defined as successful lesion modification attributable to the investigational device, demonstrated by either a) successful advancement of the laser catheter across the target lesion with effective laser-mediated plaque ablation, or b) effective plaque ablation produced by laser energy delivered proximal to the lesion, enabling subsequent balloon crossing and lesion expansion that would otherwise not have been achievable.
Detailed description
This NEON study is a prospective, multicentre, two cohort, open-label non-comparative study, conducted up to 5 clinical sites in Europe and Asia.
The primary objective of the NEON study is to generate clinical evidence demonstrating the safety and clinical performance of the Angimis Atherectomy System in subjects with non-dilatable and non-crossable coronary lesions, in support of the MDR conformity assessment. The primary endpoint will be evaluated against a predefined Performance Goal derived from historical clinical evidence using a non-inferiority statistical framework.
In addition, only for the non-dilatable cohort, a pilot phase (6 patients) will be conducted to evaluate the safety of Angimis Atherectomy System by assessing the Rate of major complications before discharge. The pivotal phase will commence after the initial safety profile is confirmed from the pilot phase. For the uncrossable lesion, there is only the pivotal phase as part of this clinical investigation.
Primary endpoint:
The primary effectiveness endpoint will assess the proportion of treated subjects in whom angiographic success was achieved. Angiographic success is defined as final TIMI flow grade 3 with residual stenosis ≤30% on quantitative coronary angiography after the procedure of balloon or stent implementation validated by an independent, centralized core laboratory.
A maximum of two target lesions may be treated with the investigational device during the index procedure. Where two target lesions are treated, one lesion shall be prospectively designated by the investigator, prior to treatment, as the Primary Target Lesion. The primary effectiveness endpoint will be assessed exclusively on the Primary Target Lesion. One additional Target Lesion may be treated during the same procedure when clinically indicated; data related to this lesion will be collected separately and included in secondary performance and safety analyses. Treatment of more than two Angimis-treated target lesions during the same index procedure is not planned in this clinical investigation.
Secondary endpoint:
- Safety:
- Rate of major complications before discharge as predefined previously 2) This endpoint will be assessed immediately after the procedure and will determine the number of patients in whom procedural success was achieved.
- This endpoint will be evaluated at 3, 6, and 12 months after the procedure and will measure the proportion of treated subjects in whom clinical success was achieved 2. Performance:
- Device Technical Success, defined as successful preparation, delivery, and use of the investigational device according to the IFU, including delivery of the laser catheter to the intended treatment location, successful delivery of laser energy, completion of the intended laser treatment without device malfunction, and retrieval of the device without device-related failure.
- Laser Success, defined as successful lesion modification attributable to the investigational device, demonstrated by either:
- successful advancement of the laser catheter across the target lesion with effective laser-mediated plaque ablation; or
- effective plaque ablation produced by laser energy delivered proximal to the lesion, enabling subsequent balloon crossing and lesion expansion that would otherwise not have been achievable The secondary performance endpoint will evaluate the laser success rate during the procedure.
- User handling:
User handling will be assessed during the procedure based on the following points:
- Pushability of the catheter,
- Crossability of the catheter,
- Retrievability of the catheter,
- readability of the system interface.
- Operability of the system
User handling procedures will ensure standardized and consistent data collection across all participating sites in different countries. Investigators and site users will be trained to record procedural details precisely, including the catheter diameter used, angiographic findings, and post-procedural assessments.
Specific instructions will be provided to ensure consistent evaluation and documentation of these performance characteristics across users and regions. Data entry interfaces will be configured to minimize variability between users and centres, with controlled terminology and predefined ranges to ensure homogeneity of reporting.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All eligible subjects will be treated by the investigational device. | Experimental | Device: Adult patient population who have been diagnosed with coronary artery disease with non-crossable and/or non-dilatable lesion which requiring the treatment of PCI |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects of age > 18 years old.
- Stenosis lesion ≥ 70% diameter stenosis as assessed by visual estimation.
- Visionally estimated the reference vessel diameter to be ≥ 2.0 mm to allow the passage of guidewire.
- Subject has at least one non-crossable and/or non-dilatable stenosis lesion. Target lesion belongs to one of the following conditions:
- 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
Key exclusion criteria (17 listed)
- Evidence of acute ischemic events
- Evidence of severe valvular pathology, based on echocardiogram result according to the investigator's assessment.
- Evidence of < 30% Left Ventricular Ejection Fraction (LVEF) based on Echocardiogram results
- Cardiogenic and non-cardiogenic shock within 3 months.
- Active bleeding or coagulopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adult patient population who have been diagnosed with coronary artery disease with non-crossable and/or non-dilatable lesion which requiring the treatment of PCIThe device is intended for the non-crossable and/or non-dilatable lesions during PCI. | Device | All eligible subjects will be treated by the investigational device. |
Primary outcome
The primary effectiveness endpoint will assess the proportion of treated subjects in whom angiographic success was achieved.
Time frame: Immediate after the procedure
Angiographic success is defined as final TIMI flow grade 3 with residual stenosis ≤30% on quantitative coronary angiography after the procedure of balloon or stent implementation validated by an independent, centralized core laboratory
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Adult patient population who have been diagnosed with coronary artery disease with non-crossable and/or non-dilatable lesion which requiring the treatment of PCI in people with Angimis Atherectomy System is Indicated for CTO, Balloon Failure and ISR in Coronary Arteries Disease, run by Shenzhen Tonglu Technology Co., Ltd.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiawen Liu Management Representative (+86 0755 26909401, wen@angio8.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary effectiveness endpoint will assess the proportion of treated subjects in whom angiographic success was achieved. (time frame: Immediate after the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.