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NCT Number: NCT07120555

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

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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

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

    Time frame: 12 months

Study contacts

Contact information is provided by the study sponsor or research team.

ahmed moustafa hassan, assistant lecturer

CONTACT

[email protected]

00201149411028

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2027
First posted
Aug 13, 2025
Registry last updated
Aug 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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