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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssiut University

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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • atherectomy

    Device

    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.

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

    Device

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

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: atherectomy + balloon angioplastyExperimental treatment 1 intervention
Group B: conventional balloon angioplastyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

• Compare the 12-month primary patency rate between the two groups.

Time frame
12 months

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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