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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).

NCT07743528 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 123

Last updated 2026-08-04

No results posted yet for this study

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. 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.

Conditions

  • Angimis Atherectomy System is Indicated for CTO, Balloon Failure and ISR in Coronary Arteries Disease

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.

Sponsors & Collaborators

  • Ospedale San'Anna

    collaborator UNKNOWN

  • University of Rome Tor Vergata

    collaborator OTHER

  • Siloam Hospitals Lippo Village

    collaborator UNKNOWN

  • Shenzhen Tonglu Technology Co., Ltd

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-15
Primary Completion
2027-05-15
Completion
2028-07-15

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07743528 on ClinicalTrials.gov