A Prospective, Single-Arm Observational Study on the Effectiveness and Safety of the DKutting® LL Balloon in VEssel Preparation for CALcified Lesions in Infra-inguinal Arteries, the DkuLL CALVEP Study.
概览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- The First Affiliated Hospital of Dalian Medical University
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- primary effectiveness outcome
概览
简要总结
This is a prospective, single-center, single-arm, observational study. It plans to enroll 58 patients with moderate to severely calcified lesions in the femoropopliteal or infrapopliteal arteries. Participants will be treated with the Scoring Balloon Dilatation Catheter manufactured by DK Medtech (Suzhou) Co., Ltd. The study aims to evaluate the immediate technical success rate and the improvement in lumen area and calcification burden as assessed by IVUS following percutaneous transluminal angioplasty with the scoring balloon. Clinical follow-ups will be conducted at discharge (or within 7 days), 1 month, 3 months, and 6 months post-procedure to observe secondary endpoints including the incidence of clinically driven target lesion revascularization and changes in Rutherford classification
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years and ≤ 85 years.
- •Clinical diagnosis of lower extremity atherosclerotic arterial disease, with a Rutherford Classification of Category 2-
- •The patient has provided written informed consent.
- •Life expectancy \> 1 year.
- •Confirmed by clinical and CTA examination: de novo or restenotic lesions after PTA in the femoropopliteal or infrapopliteal arteries, with no stent implantation within 2 cm of the target lesion. Stenosis ≥70% or chronic total occlusion (CTO).
- •Lesion confirmed by CTA and color Doppler to have moderate to severe calcification (PACSS Grade 3-4). Lesion can be single or tandem, with a total length ≤150 mm. Reference vessel diameter near the target lesion ≥2 mm.
- •Allowable location of the target lesion: ≥1 cm distal to the common femoral artery bifurcation, and up to 10 cm above the ankle.
- •If the lesion is below-the-knee (BTK), the inflow vessels must have no non-target lesions, or any non-target lesions must be successfully treated with the current device without vascular complications.
- •No serious vascular complications such as flow-limiting dissection occur after pre-dilation of the target lesion.
- •Presence of at least one reconstructible infrapopliteal runoff vessel patent to the ankle.
排除标准
- •Allergy to contrast media.
- •Coagulopathy; severe hepatic insufficiency (ALT or AST \> 3 times the upper limit of normal).
- •Cardiac insufficiency (New York Heart Association Class III-IV).
- •Life expectancy \< 1 year.
- •Acute cardiovascular events (e.g., acute myocardial infarction, stroke) within the past 3 months; active gastrointestinal bleeding affecting the use of anticoagulant/antiplatelet therapy.
- •Previous stent implantation or bypass surgery in the target vessel.
- •Acute/subacute limb ischemia or thrombotic lesions.
- •Contraindications to anticoagulation or antiplatelet therapy.
- •Failure to cross the lesion with a guidewire during the procedure; anticipation that the IVUS catheter or DKutting balloon will be unable to cross the lesion after pre-dilation.
- •Intraoperative occurrence of severe complications requiring conversion to other treatment methods (e.g., bypass surgery).
研究组 & 干预措施
Dkutting LL treatment group
IVUS facilitated DKutting LL angioplasty
干预措施: DKutting LL scoring balloon angioplasty (Device)
结局指标
主要结局
primary effectiveness outcome
时间窗: immediately after the intervention
Technical Success Rate: Definition: Immediate post-procedural residual stenosis ≤30% after dilation with the Scoring Balloon Dilatation Catheter or a conventional balloon catheter, and without the occurrence of severe flow-limiting dissection (Grade D-F according to the National Heart, Lung, and Blood Institute (NHLBI) classification).
primary safety outcome
时间窗: 1 month
Incidence of emergency target lesion revascularization, unplanned amputation above the ankle on the target side, or grade D or higher flow-limiting dissection or perforation requiring intervention
次要结局
- Primary Patency Rate at 30 days(1 month)
- Primary Patency Rate at 6 months(6 months)
- Incidence of Clinically Driven Target Lesion Revascularization (CD-TLR) at 6 months(6 months)
- Change in Rutherford Classification at 1 month post-procedure(1 month)
- Intraoperative Complication Rate Related to Percutaneous Transluminal Angioplasty (PTA)(immediately after the intervention)
- ΔMLA (Change in Minimum Lumen Area)(immediately after the intervention)
- ΔCalcification Burden Improvement(immediately after the intervention)
研究者
Ji Donghua
Medical Doctor, Chief Physician, The First Affiliated Hospital of Dalian Medical University
The First Affiliated Hospital of Dalian Medical University