NCT05846893进行中（未招募）不适用
Randomised Trial of Drug-Coated Balloon Versus Drug-Eluting Stent for Clinical Outcomes in Patients With Large Coronary Artery Disease
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,436
- 试验地点
- 39
- 主要终点
- Net Adverse Clinical Event (NACE)
研究概览
简要总结
Prospective, randomised, open-label, international multicenter trial to evaluate the safety and efficacy of drug-coated balloon (DCB) treatment compared to drug-eluting stenting (DES) in patients with large coronary artery disease.
详细描述
Although several reports suggested that DCB application was safe for larger coronary artery lesions and showed good long-term outcomes, there is limited randomised controlled trial (RCT) data on the safety and efficacy of DCB in large coronary artery disease.
Therefore, the study aims to demonstrate the non-inferiority of the drug-coated balloon (DCB) treatment against current-generation drug-eluting stenting (DES) in patients with de novo lesions in large coronary artery disease (reference vessel diameter ≥3.0 mm by visual estimation).
The hypothesis of the study is the clinical outcomes of patients treated with DCB are non-inferior to those treated with current-generation DES.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient-related:
- •Patient must be ≥ 18 years of age
- •Patient is able to verbally confirm understanding of the study aim, risks, benefits, and treatment alternatives of receiving DCB or DES and he/she or his/her legally authorized representative provides written informed consent prior to any study-related procedure
- •(i) Clinical evidence of angina, and/or (ii) an abnormal functional study demonstrating myocardial ischemia due to the target lesion(s), or (iii) acute coronary syndrome [unstable angina or non-ST-elevation myocardial infarction (NSTEMI) or uneventful STEMI (≥ 48 hours after primary PCI and no sign of thrombus in lesion(s) to treat)]
- •Patient with lesions suitable for PCI with a DCB (and/or DES) according to the Instructions for Use
- •Patient is able to comply with the study protocol and agrees to undergo the clinical follow-up of 30 days, 6 months, 12 months, 24 months, and 36 months
- •Lesion-related:
- •Presence of significant de novo large vessel coronary artery disease (reference vessel diameter ≥3.0 mm by visual estimation) with either ≥ 70% diameter stenosis or intermediate ≥ 50% to <70% diameter stenosis with abnormal functional test or symptom of ischemia
- •Successful lesion preparation. For randomisation, the lesion must satisfy the following criteria after optimal balloon angioplasty: no flow-limiting dissection (TIMI=3), and residual stenosis is ≤ 30%
- •Multivessel disease with two or more vessels showing diameter stenosis of 50% or more is not an exclusion as long as it fulfills all study's eligibility criteria.
- •In diffuse lesion, inclusion is possible if the proximal reference vessel diameter is 3.0 mm or more.
排除标准
- •Patient-related:
- •Intolerance or allergy to Paclitaxel and/or the delivery matrix (main ingredient: Iopromide)
- •Severe allergy to contrast media
- •Recent STEMI (ongoing or < 48 hours after primary PCI and/or has sign of thrombus in lesion(s) to treat)
- •NSTEMI hemodynamically unstable
- •Known left ventricular ejection fraction of <30%
- •Inability to take dual antiplatelet therapy or anticoagulation, or single antiplatelet therapy for at least six months
- •Non-cardiac co-morbid conditions that may result in protocol non-compliance and inability of patient to complete the study (per the site investigator's medical judgment)
- •Patient with concomitant medical illnesses that require cytostatic, radiation therapy or renal replacement therapy
- •Patient who is currently/ planning to participate in another clinical trial when such participation could confound the treatment or outcomes of this study, except for observational registry
- •Pregnancy or lactation
- •Patient under administrative or judicial custody
- •Lesion-related:
- •Small vessel disease, defined as <3.0 mm of reference vessel diameter by visual estimation
- •In-stent restenosis lesions for study lesions
- •Patient will be excluded if meet any of the following angiographic exclusion criteria after lesion preparation:
- •(i) Flow limiting dissection with TIMI flow < III (ii) Residual diameter stenosis >30%
- •* The case of persistent ischemic symptoms/signs is up to the operator's decision
- •Lesions which are untreatable with PCI or other interventional techniques and coronary artery spasm in the absence of a significant stenosis
- •Left main disease or aorta-ostial lesion requiring revascularization
- •Severely calcified or tortuous vessels precluding DCB or DES application
- •Prior Coronary Artery Bypass Graft (CABG)
研究组 & 干预措施
SeQuent® Please NEO drug-coated balloon catheter
Experimental
干预措施: SeQuent® Please NEO drug-coated balloon catheter (Device)
Current-generation drug-eluting stent
Experimental
干预措施: Current-generation drug-eluting stent (Device)
结局指标
主要结局
Net Adverse Clinical Event (NACE)
时间窗: At 1 year
Net adverse clinical event (NACE): a composite of all-cause death, non-fatal myocardial infarction, clinically driven target vessel revascularization, or major bleeding (BARC type 3 to 5)
次要结局
- Target vessel myocardial infarction(At 12, 24, and 36 months)
- Fluoroscopy time of the angioplasty procedure(During the index procedure)
- Contrast volume of the angioplasty procedure(During the index procedure)
- All-cause death(At 12, 24, and 36 months)
- Clinically driven target vessel revascularization(At 12, 24, and 36 months)
- Major bleeding (BARC type 3 to 5)(At 12, 24, and 36 months)
- Periprocedural myocardial infarction(At 12, 24, and 36 months)
- Target lesion revascularization(At 12, 24, and 36 months)
- Rehospitalization related to study endpoints(At 30 days, 12 months, 24 months, and 36 months)
- Stroke (ischemic and hemorrhagic)(At 12, 24, and 36 months)
- Non-fatal myocardial infarction(At 12, 24, and 36 months)
- Stent/lesion thrombosis in treated lesion defined according to the Academic Research Consortium-2 (ARC-2) criteria(At 12, 24, and 36 months)
- Total angioplasty procedure time(During the index procedure)
- Number of devices (DCB/ DES) used for PCI treatment(During the index procedure)
- Cardiac death(At 12, 24, and 36 months)
研究者
研究点 (39)
Loading locations...
相似试验
进行中（未招募）
不适用
STrategies of Scheduled Drug-coated Balloons (DCB) Versus Conventional DES for the interveNTional Therapy of de Novo Lesions in Large Coronary vESSels (STENTLESS) TrialDrug-coated BalloonDrug-eluting StentDe Novo StenosisNCT06084000China National Center for Cardiovascular Diseases2,700
招募中
不适用
ACOART Intracranial ISR Pilot:Intracranial DCB in the Treatment of Intracranial In-stent RestenosisIntracranial AtherosclerosisStrokeNCT04627870Acotec Scientific Co., Ltd20
招募中
不适用
DCB vs. DES in Bifurcation Coronary LesionsDCBCoronary Artery DiseaseNCT06551662Fondazione Ricerca e Innovazione Cardiovascolare ETS321
Unknown
不适用
A Trail of Drug-coated Balloon Treating Below The Knee Arterial DiseasesPeripheral Artery DiseaseNCT05415995Zhejiang Zylox Medical Device Co., Ltd.202
已完成
不适用
A Randomized Trial of a Biolimus-Coated Balloon Versus POBA in Small Vessel Coronary Artery DiseaseCoronary Artery DiseaseNCT03769623JW Medical Systems Ltd206