Outcomes of Atherectomy and Balloon Angioplasty Compared to Conventional Angioplasty in Infra-popliteal Chronic Limb-Threatening Ischemia

Assiut University

Status: Not yet enrolling

Conditions: Chronic Limb Threatening Ischemia

Treatments: Device: atherectomy; Device: Percutaneous transluminal angioplasty of infra-popliteal arteries lesions with primary long

Study type: Interventional

Funder types: Other

Identifiers

NCT07120555

DFGCUOHBTR

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

All patients present with CLTI due to isolated infra-popliteal disease with the following criteria:

• Denovo or Recoil
• Reference tibial vessel diameter at least (2mm)
• The diseased tibial artery has a patent distal segment supplying the foot

Exclusion criteria

• Patients present with:

  • Previous ipsilateral infrapopliteal bypass surgery
  • Concomitant iliac or femoral artery lesion
  • Isolated pedal arch disease
  • previous atherectomy
  • Faliure to cross the lesion
  • Known hypercoagulable disorder or non-atherosclerotic vasculopathy
  • Severe renal insufficiency (eGFR <30) not on dialysis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

atherectomy + balloon angioplasty

Experimental group

Treatment:

Device: atherectomy

conventional balloon angioplasty

Experimental group

Treatment:

Device: Percutaneous transluminal angioplasty of infra-popliteal arteries lesions with primary long