About this trial
Chronic limb-threatening ischemia (CLTI) represents the most advanced stage of peripheral artery disease (PAD), characterized by rest pain, non-healing ulcers, or gangrene, and is associated with high morbidity and risk of amputation if left untreated. Infra-popliteal arteries are frequently involved in CLTI, especially in diabetic and elderly patients, posing significant challenges due to diffuse, calcified, and long-segment occlusive lesions.
Conventional balloon angioplasty remains a first-line endovascular treatment but is limited by high restenosis and vessel recoil rates. Atherectomy, a plaque debulking technique, aims to improve luminal gain and vessel compliance prior to angioplasty, potentially enhancing outcomes in heavily calcified lesions. The combination of atherectomy and balloon angioplasty has shown promise in reducing dissection rates and improving technical success, yet its superiority over conventional angioplasty alone remains controversial.
Given the growing use of endovascular therapies, a comparative analysis of outcomes between combined atherectomy-balloon angioplasty and conventional angioplasty in infra-popliteal interventions is essential to guide evidence-based management in CLTI patients.
Eligibility criteria
Qualifiers
Denovo or Recoil
Reference tibial vessel diameter at least (2mm)
The diseased tibial artery has a patent distal segment supplying the foot
Disqualifiers
Previous ipsilateral infrapopliteal bypass surgery
Concomitant iliac or femoral artery lesion
Isolated pedal arch disease
previous atherectomy
Trial design
Treatments tested in this trial
- atherectomy
- Percutaneous transluminal angioplasty of infra-popliteal arteries lesions with primary long