Oucomes of Endovascular Atherectomy in Femoropopliteal Arterial Disease

Assiut University

Status: Active, not recruiting

Conditions: Chronic Threatening Limb Ischemia

Treatments: Device: Endovascular Atherectomy

Study type: Observational

Funder types: Other

Identifiers

NCT07239089

AssiutU

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

60 participants in 1 patient group

sample size is 60 patients (30 in each group).

Treatment:

Device: Endovascular Atherectomy