NCT07743528Toborzás még nem indult
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).
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. aug. 4.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Toborzás még nem indult
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 123 (tervezett)
- Első benyújtás
- 2026. júl. 30.
- Kezdés
- 2026. szept. 15.
- Elsődleges befejezés
- 2027. máj. 15.
- Fő szponzor
- Shenzhen Tonglu Technology Co., Ltd
- NCT-szám
- NCT07743528
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 123
- 2026. szept. 15. és az elsődleges befejezés (2027. máj. 15.) között
- Nincs megadott helyszín, ország nélkül
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Korábbi kezelés
- 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)
Más betegség
- 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.
Laborértékek
- 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.
Egyéb
- 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
Kiket keres a vizsgálat
- 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
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