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NCT Number: NCT07142330

Evaluation of Atherectomy in the Management of Occlusive Lesions of the Common Femoral Arteries

Thromboendarterectomy is the standard technique for the treatment of symptomatic occlusive lesions of the common femoral artery. It consists of surgically controlling the artery and interrupting circulation, opening the vessel and removing the atherosclerotic plaque. However, this technique is associated with healing difficulties, postoperative infections, and debilitating incisional pain. The rise of endovascular therapies, particularly at the coronary level, has led to the emergence of new deocclusion techniques, including rotational atherectomy. This technique relies on the use of an intravascular catheter that reams out the atherosclerotic plaque while re-aspirating the resulting debris. A few studies have examined the use of rotational atherectomy for occlusive lesions of the common femoral arteries, but have not evaluated its results compared to the standard treatment. The aim of this multicenter cohort is to describe the efficacy and safety of rotational atherectomy and the standard treatment, thromboendarterectomy, in symptomatic occlusive lesions affecting the common femoral artery.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male or female patient over 18 years of age
  • Non-emergency
  • Claudicating patient with significant de novo calcified stenosis affecting the common femoral artery, technically eligible for revascularization by thromboendarterectomy or rotational atherectomy
  • Surgery planned with either technique
  • Patient's consent to participate in the study must be obtained,

Exclusion criteria

  • Patient contraindicated for either technique (for surgical or anesthesiological reasons)
  • Patient with asymptomatic lesions of the common femoral artery
  • Patient with a history of surgery or angioplasty/stenting of the femoral stump
  • Patient with occlusion of the ipsilateral common femoral artery or external iliac artery
  • Patient with an indication for additional aortofemoral, iliofemoral, femoral-popliteal, or hamstring bypass
  • Patient with severe trophic disorders for which a major amputation is considered immediately in addition to revascularization
  • Patient objecting to the use of their data

Treatment and study plan

Atherectomy

Procedure

Two different techniques : rotational atherectomy or thromboendarterectomy

Primary outcomes

  1. Local complications

    Time frame: one month

    Local complications are defined as follows: hematoma, active bleeding, local infection, thrombosis, delayed healing, false aneurysm, arteriovenous fistula, and neuropathic pain following surgical trauma.

Study contacts

Contact information is provided by the study sponsor or research team.

Adrien HERTAULT, Dr

CONTACT

[email protected]

0033620055568

Sponsors and collaborators

Lead sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Other

Registry information

Official study title

Evaluation of Atherectomy in the Management of Occlusive Lesions of the Common Femoral Arteries (RAFAL)

Acronym: RAFAL

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 26, 2025
Registry last updated
Aug 26, 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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