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

Not Applicable

Not yet recruiting

• Conditions: Chronic Limb Threatening Ischemia

• Registration Number: NCT07120555
• Lead Sponsor: Assiut University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-07-16
• Status Verified: 2025-08
• Study First Submitted QC: 2025-08-12
• Last Update Submitted: 2025-08-12
• Study First Posted: 2025-08-13
• Last Update Posted: 2025-08-13
• Study Start: 2025-09-30
• Primary Completion: 2025-12-30
• Study Completion: 2027-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
• Compare the 12-month primary patency rate between the two groups.	12 months