NCT07743528Not yet recruiting

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 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).

Source: ClinicalTrials.gov · Last updated 4 Aug 2026

Brief summary (registry, in English)

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.

Status (registry): Not yet recruiting
Study type: Interventional
Enrollment: 123 (estimated)
First submitted: 30 Jul 2026
Start date: 15 Sept 2026
Primary completion date: 15 May 2027
Lead sponsor: Shenzhen Tonglu Technology Co., Ltd
NCT number: NCT07743528

What you commit to

Study type: Interventional
Planned participants: 123
From 15 Sept 2026 to the primary completion date, 15 May 2027
No sites listed in no country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

Previous coronary angioplasty within 3 months of the index procedure
Planned surgery within 6 months of enrolment in this study
Patients known to be suffering from substance abuse (alcohol or drug)

Other illness

Active bleeding or coagulopathy
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
Patients with any other significant co-morbid illness which, in the opinion of the investigator, are not conducive to inclusion in the study.

Lab values

Evidence of \< 30% Left Ventricular Ejection Fraction (LVEF) based on Echocardiogram results
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.

Other

Evidence of acute ischemic events
Evidence of severe valvular pathology, based on echocardiogram result according to the investigator's assessment.
Cardiogenic and non-cardiogenic shock within 3 months.
Patients participating in another trial for which the primary endpoint has not be reached
Life expectancy is less than 6 months
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

Who the study is looking for

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

Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.