Oucomes of Endovascular Atherectomy in Femoropopliteal Arterial Disease

Outcomes of Endovascular Atherectomy in Femoropopliteal Arterial Disease

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07239089

Enrollment

Registered

2025-11-20

Start date

2025-10-01

Completion date

2027-10-22

Last updated

2025-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Threatening Limb Ischemia

Brief summary

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.

Interventions

DEVICEEndovascular Atherectomy

Endovascular Atherectomy in femoropopliteal arterial disease

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

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

Design outcomes

Primary

Measure	Time frame	Description
Technical success	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.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026