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NCT Number: NCT07239089

Oucomes of Endovascular Atherectomy in Femoropopliteal Arterial Disease

Peripheral artery disease (PAD) affects >200 millionadults worldwide and is amajor cause of morbidity ranging from exertional lower extremity pain to ischemic rest pain and ulcer formation.

Endovascular treatment options for PAD have increased dramatically in the past several decades. The traditional endovascular treatment of severe PAD has been balloon angioplasty with or without adjunctive stenting.

The outcomes of balloon angioplasty and stenting are acceptable for short lesion lengths in the superficial femoral artery (SFA) and proximal popliteal arteries.Therefore, there is an established need for technologies that can adequately treat more complex femoropopliteal lesions.

Endovascular atherectomy has emerged as a novel technique for atheroma removal in patients with disease of the SFA or popliteal arteries. Atherectomy offers the advantages of surgical endarterectomy by removing atherosclerotic plaque while remaining a minimally invasive and percutaneous treatment.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Chronic Threatening Limb Ischemia Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Chronic Disease Chronic Limb-Threatening Ischemia Disease Attributes Ischemia Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Arterial Disease Peripheral Vascular Diseases Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Assiut university

Ţahţā, Sohag Governorate, 75577, Egypt

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • All patients present with CLTI due to femoropopliteal artery disease with the following criteria:
  • Denovo or Recoil
  • Stenosis or occlusion

Exclusion criteria

  • Patients present with:
  • Previous ipsilateral bypass surgery
  • In-stent restenosis or previous atherectomy
  • Known hypercoagulable disorder or non-atherosclerotic vasculopathy
  • Severe renal insufficiency (eGFR <30) not on dialysis
  • Inability to provide informed consent

Treatment and study plan

Endovascular Atherectomy

Device

Endovascular Atherectomy in femoropopliteal arterial disease

Primary outcomes

  1. Technical success

    Time frame: From october 2025 to october 2027

    completion of the endovascular procedure without the need for further intervention for revascularization and an absence of substantial or complete occlusion in SFA at final angiography.

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Outcomes of Endovascular Atherectomy in Femoropopliteal Arterial Disease

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Nov 20, 2025
Registry last updated
Nov 20, 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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