NCT07136883已完成不适用
Drug-coated Balloon Angioplasty Outcomes After Plain or Scoring Balloon for Vessel Preparation in Patients With Femoropopliteal Arterial Disease. The DASBAD Study: A Prospective Randomized Controlled Trial.
Marc Sirvent2 个研究点 分布在 1 个国家目标入组 83 人开始时间: 2020年9月25日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 83
- 试验地点
- 2
- 主要终点
- Bailout stenting
研究概览
简要总结
The goal of this clinical trial is to learn if using a scoring balloon to prepare the femoropopliteal (FP) segment before drug-coated balloon treatment works better than using a regular balloon (called plain old balloon angioplasty, or POBA). This study includes only people with critical limb ischemia (CLI).
The main questions it aims to answer are:
- Does using a scoring balloon reduce the need for a bailout stent during the procedure?
- Does a scoring balloon help keep the artery open longer?
- Is the cost of the scoring balloon procedure similar to the cost of the POBA procedure?
Participants will:
- Receive either a scoring balloon or POBA to prepare the femoropopliteal segment
- Then be treated with a drug-coated balloon in the same segment
- Be monitored during the procedure to see if a bailout stent is needed
- Have follow-up visits to see if the artery remains open
详细描述
A prospective, single-center clinical trial has been designed with two parallel intervention groups of consecutive CLI patients (Rutherford classification 4-5) with lesions in the F-P segment. It is a single-blind study, where the patient is unaware of their group allocation, but the operator knows the group of each patient.
Patients will be randomly assigned to undergo either conventional balloon angioplasty or AngioSculpt™ scoring balloon angioplasty prior to drug-coated balloon (Luminor™) treatment.
PROCEDURE DESCRIPTION
Antithrombotic Therapy (Pre-, Intra-, and Post-Procedure):
All patients will be on at least single antiplatelet therapy prior to the procedure, receiving either aspirin (100-300 mg/day) or clopidogrel (75 mg/day).
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)
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
- •Male or non-pregnant female subjects aged ≥18 years at the time of informed consent. Women of childbearing potential must have a negative pregnancy test within 7 days prior to the procedure and must agree to use a reliable method of contraception during their participation in the study. This requirement does not apply in cases of sterility, infertility, or menopause for at least 12 months.
- •Rutherford category 4-
- •Life expectancy >1 year as assessed by the investigator, based on the patient's medical history.
- •Atherosclerotic lesions in the femoropopliteal segment, including in-stent restenosis.
- •The subject has been informed, understands the nature of the trial, and has signed the informed consent form to participate in the study. If the subject is capable of understanding and providing informed consent but is physically unable to sign the consent form, an impartial witness may sign on their behalf.
- •The patient is willing to comply with all required follow-up visits.
- •Presence of at least one patent infragenicular artery (with <50% stenosis) at the end of the procedure.
- •Target vessel diameter ≤8 mm.
排除标准
- •Pregnant women or women planning to become pregnant during the course of the study.
- •Participation in another investigational drug eluting technology study.
- •Inability to successfully cross the target lesion with a guidewire (successful crossing is defined as the guidewire tip passing through the lesion without perforation and remaining within the true arterial lumen).
- •Inadequate treatment of a proximal lesion (defined as >30% residual stenosis).
- •Severe calcification of the target vessel, defined as 270-360 degrees of circumferential calcification (Fanelli grade 4 classification).
- •Presence of thrombus in the target vessel.
- •Stenosis at the anastomosis site of a bypass.
- •Use of atherectomy, thrombectomy, laser, or any similar device in the target lesion/vessel.
- •Prior or planned above-ankle amputation of the target limb (this does not apply to transmetatarsal, digital amputations, or ulcer debridement).
- •Known coagulopathy, hypercoagulable state, bleeding diathesis, platelet count <80,000/μL or >700,000/μL, or any other hematological disorder.
- •History of gastrointestinal bleeding requiring transfusion within the 3 months prior to the study procedure.
- •Any subject for whom the use of antiplatelet, anticoagulant, or thrombolytic therapy is contraindicated.
- •Acute coronary syndrome within 30 days prior to the index procedure.
- •History of stroke or transient ischemic attack (TIA) within 90 days prior to the index procedure.
- •Known hypersensitivity or contraindication to nickel-titanium alloy (Nitinol).
- •Other comorbidities that, in the opinion of the investigator, would prevent the subject from receiving this treatment and/or from complying with the follow-up required by this trial.
- •Known hypersensitivity or allergy to contrast agents that cannot be managed medically.
- •Known hypersensitivity or allergy to heparin, aspirin, paclitaxel, clopidogrel, or other antiplatelet/anticoagulant therapies.
- •Contraindication to the use of dual antiplatelet therapy.
结局指标
主要结局
Bailout stenting
时间窗: At index procedure
The need for bailout stenting during the index procedure, defined as implantation due to residual stenosis \>30% or flow-limiting dissection (type C according to the Kobayashi classification)
Primary patency
时间窗: 12 months
Defined by duplex ultrasound as absence of ≥50% restenosis (velocity peak ratio \<2.5) and no clinically driven target lesion revascularisation (CD-TLR)
次要结局
- Primary patency(1, 6, 18 and 24 months)
- Clinically Driven Target Lesion Revascularization (CD-TLR)(At 1 month, every 6 months up to 2 years post-procedure)
- Freedom from device and procedure-related death and freedom from Major Adverse Events (MAE), including Major Adverse Clinical Events (MACE) and Major Adverse Limb Events(MALE)(1- Freedom from device and procedure-related death through 30 days post-procedure 2- Freedom from MAE (MACE and MALE) at 1 month, every 6 months up to 2 years post-procedure.)
- Technical success(During the procedure)
- Procedural success(Occurring <24 hours and <1 month of the procedure)
- Wound healing time(The observation period extends from the date of randomization until the earliest of the following: wound healing, death from any cause, or study completion.)
- Primary patency(1, 6, 18 and 24 months)
- Clinically Driven Target Lesion Revascularization (CD-TLR)(At 1 month, every 6 months up to 2 years post-procedure)
- Freedom from device and procedure-related death and freedom from Major Adverse Events (MAE), including Major Adverse Clinical Events (MACE) and Major Adverse Limb Events(MALE)(1- Freedom from device and procedure-related death through 30 days post-procedure 2- Freedom from MAE (MACE and MALE) at 1 month, every 6 months up to 2 years post-procedure.)
- Technical success(During the procedure)
- Procedural success(Occurring <24 hours and <1 month of the procedure)
- Wound healing time(The observation period extends from the date of randomization until the earliest of the following: wound healing, death from any cause, or study completion.)
- Procedural cost(Index procedure)
研究者
Marc Sirvent
Head of Angiology and Vascular Surgery Department, Principal investigator
Hospital de Granollers
研究点 (2)
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