Oucomes of Endovascular Atherectomy in Femoropopliteal Arterial Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-10-01

Study Completion Date

2027-10-22

Brief Summary

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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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Detailed Description

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Conditions

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Chronic Threatening Limb Ischemia

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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

Endovascular Atherectomy

Intervention Type DEVICE

Endovascular Atherectomy in femoropopliteal arterial disease

Interventions

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Endovascular Atherectomy

Endovascular Atherectomy in femoropopliteal arterial disease

Intervention Type DEVICE

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No