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).

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).

Overview

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:

1\. Safety:

1\) 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.

3\) 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:

1. 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. 2. 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.

3\. User handling:

User handling will be assessed during the procedure based on the following points:

1. Pushability of the catheter, 2. Crossability of the catheter, 3. Retrievability of the catheter, 4. readability of the system interface. 5. 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.

Interventions

• 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
  The device is intended for the non-crossable and/or non-dilatable lesions during PCI.

Primary outcome measures

• The primary effectiveness endpoint will assess the proportion of treated subjects in whom angiographic success was achieved. [Time frame: Immediate after the procedure]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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
• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07743528 · NEON-2026

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗