NCT07743528
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).
Not Yet Recruiting · Not Applicable · Shenzhen Tonglu Technology Co., Ltd · registry updated 2026-08-04
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
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....
Inclusion
- 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
Exclusion
- 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