Drug-coated Balloon Angioplasty After Non-Compliant Balloon Vessel Preparation With or Without Scoring for Femoropopliteal Arterial Disease: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 142
- 主要终点
- Primary Patency
研究概览
简要总结
The aim of this clinical trial is to determine whether vessel preparation with a non-compliant scoring balloon before drug-coated balloon (DCB) angioplasty provides superior procedural and clinical outcomes compared with vessel preparation using a non-compliant plain balloon in patients with chronic limb-threatening ischaemia (CLTI) undergoing femoropopliteal endovascular intervention.
The main questions the study aims to answer are:
- Does non-compliant scoring balloon vessel preparation reduce the need for bailout stenting during the index procedure?
- Does it improve primary patency after DCB angioplasty?
- Does it improve clinically relevant outcomes such as wound healing, freedom from clinically driven target lesion revascularisation, limb salvage and health-related quality of life?
- Does it provide procedural and economic advantages compared with non-compliant plain balloon vessel preparation?
Participants will be randomly assigned to undergo vessel preparation using either a non-compliant plain balloon or the DKutting™ non-compliant scoring balloon, followed by angioplasty with the Legflow XP™ drug-coated balloon. Patients will undergo clinical, duplex ultrasound and quality-of-life follow-up for 24 months.
详细描述
The DASBAD-NC trial is a prospective, multicentre, randomised, patient-blinded, controlled clinical investigation designed to compare two vessel preparation strategies before drug-coated balloon (DCB) angioplasty for femoropopliteal arterial disease in patients with chronic limb-threatening ischaemia (Rutherford classification 4-5).
Eligible patients with significant atherosclerotic femoropopliteal disease (≥50% stenosis or chronic total occlusion) will be randomised in a 1:1 ratio, after successful guidewire crossing of the target lesion and confirmation of all eligibility criteria, to one of two treatment strategies:
- Vessel preparation using a non-compliant plain balloon (PBA arm), followed by Legflow XP™ drug-coated balloon angioplasty.
- Vessel preparation using the DKutting™ non-compliant scoring balloon (SB arm), followed by Legflow XP™ drug-coated balloon angioplasty.
Vessel preparation will be performed using a 1:1 balloon-to-reference vessel diameter ratio with a minimum inflation time of 180 seconds. Predilatation with a smaller balloon will only be permitted if the allocated study balloon cannot cross the lesion. Drug-coated balloon angioplasty will subsequently be performed using the Legflow XP™ drug-coated balloon according to the study protocol. Bailout stenting will only be permitted in the presence of residual stenosis ≥30% and/or flow-limiting dissection after DCB treatment.
The co-primary endpoints are bailout stenting during the index procedure and primary patency at 12 months. Secondary endpoints include freedom from clinically driven target lesion revascularisation, target limb major amputation, all-cause mortality, wound healing, health-related quality of life, procedural success, slow-flow phenomenon, procedural costs and other prespecified clinical and imaging outcomes.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Participants and outcome assessors will remain blinded to treatment allocation. Treating physicians and investigators responsible for the index procedure cannot be blinded because of the nature of the intervention. Duplex ultrasound follow-up examinations will undergo blinded central review by an independent core laboratory. Clinical events will be adjudicated by an independent Clinical Events Committee blinded to treatment allocation. Procedural angiographic outcomes will undergo an independent blinded quality assurance review after database lock. Statistical analyses will be performed by an independent statistician blinded to treatment allocation until completion of the primary analysis.
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
- •≥18 years of age.
- •Rutherford class 4-
- •Estimated life expectancy >1 year, per investigator's judgment.
- •Significant atherosclerotic lesions (≥50% stenosis or chronic total occlusion) in the femoropopliteal segment, including in-stent restenosis.
- •Signed informed consent.
- •Willingness to comply with follow-up visits.
- •≥1 patent infragenicular artery (<50% stenosis) at the end of the procedure.
- •Target vessel diameter ≤8 mm.
排除标准
- •Pregnant or planning pregnancy during the study.
- •Participation in another drug/device trial.
- •Inability to cross the target lesion with a guidewire. Successful crossing is defined as advancement of the guidewire tip distal to the target lesion without vessel perforation or flow-limiting dissection.
- •Inadequate treatment of proximal lesion (>30% residual stenosis).
- •Severe calcification of the target vessel [group 4 of Fanelli classification17 defined as circumferential calcification (270º-360º)], evidenced before contrast injection or digital subtraction angiography.
- •Thrombus in the target vessel.
- •Anastomotic stenosis of a bypass.
- •Use of atherectomy, thrombectomy, laser, or similar devices.
- •Prior or planned above-the-ankle amputation of the target limb.
- •Coagulopathy, hypercoagulable state, bleeding diathesis, platelets <80 000/µL or >700 000/µL, or other blood disorder.
- •Gastrointestinal bleeding requiring transfusion within 3 months.
- •Contraindication to antiplatelet/anticoagulant/thrombolytic therapy.
- •Acute coronary syndrome within 30 days.
- •Stroke or TIA within 90 days.
- •Hypersensitivity/contraindication to nitinol.
- •Comorbidities precluding treatment or follow-up (per investigator).
- •Hypersensitivity/allergy to contrast not manageable medically.
- •Hypersensitivity/allergy to heparin, aspirin, paclitaxel, clopidogrel, or other antiplatelet/anticoagulant agents.
- •Contraindication to dual antiplatelet therapy.
研究组 & 干预措施
Scoring balloon (SB)
- Vessel preparation using non-compliant scoring balloon (DKutting™; Manufacturer: DK Medical Technology Co., Ltd., Suzhou, China)
- Definitive treatment: drug-coated balloon angioplasty (Legflow XP™; Manufacturer: Cardionovum GmbH Bonn, Germany) as definitve treatment.
干预措施: Non-compliant Scoring Balloon Angioplasty (SB) (Device)
Non-compliant plain balloon (PBA)
- Vessel preparation using non-compliant plain balloon
- Definitive treatment: drug-coated balloon angioplasty (Legflow XP™; Manufacturer: Cardionovum GmbH Bonn, Germany).
干预措施: Non-compliant Plain Balloon angioplasty (PBA) (Device)
结局指标
主要结局
Primary Patency
时间窗: At 12 months
Primary patency at 12 months defined as absence of ≥50% restenosis (peak systolic velocity ratio\<2.5) and no clinically driven target lesion revascularisation (CD-TLR), as adjudicated by the duplex core laboratory and the Clinical Events Committee.
Bailout stenting
时间窗: At index procedure
The need for bailout stenting during the index procedure, defined as stent implantation due to residual stenosis \>30% or a flow-limiting dissection (type C according to the Kobayashi classification)
次要结局
- Device success(During the index procedure)
- Technical success(During the index procedure.)
- Procedural cost(During the index procedure)
- Slow-flow phenomenon(During the index procedure)
- Procedural success(Occurring <24 hours and <1 month of the index procedure.)
- Freedom from device and procedure-related death(Until 30 days post-procedure)
- Freedom from Major Adverse Events (MAE)(Up to 24 months post-procedure)
- Primary patency(At 6 and 24 months post-procedure)
- Freedom from CD-TLR(Up to 24 months post-procedure)
- Improvement in Rutherford classification(Up to 24 months post-procedure.)
- Change in EQ-5D questionnaire(Up to 24 months post-procedure)
- Amputation free survival(Up to 24 months post-procedure.)
- Wound healing evolution(Up to 24 months post-procedure)
- Wound healing time(Days from the index procedure to complete epithelialisation of the target wound)
- Change in Rutherford classification(Up to 24 months post-procedure.)
研究者
Marc Sirvent
PhD, MD, FEBVS, Head of the Department of Angiology and Vascular Surgery, Hospital General de Granollers
Hospital de Granollers