Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07147556

Surgical Treatment of Functional Popliteal Artery Entrapment Syndrome: Short- and Mid-Term Results

Functional popliteal artery entrapment syndrome (FPAES) is a rare and under-diagnosed clinical entity characterized by dynamic compression of the popliteal artery during exercise in the absence of a visible anatomic abnormality at rest. It preferentially affects young, otherwise healthy athletes (3,4). Although surgical release is the reference treatment, the literature relies mainly on small case series, surgical management is poorly standardized, and data on early post-operative morbidity (complications, re-hospitalization) are often lacking. This prospective, single-center, non-interventional study aims to describe the safety of the surgical management of FPAES as performed in routine care in the vascular surgery department of Ambroise Paré Hospital (AP-HP), a national reference center for this condition. The primary endpoint is the rate of re-hospitalization within 30 days of surgery. Secondary objectives address risk factors for re-hospitalization, minor adverse events, and the clinical and functional outcome of patients, including return to sport, assessed using the Lower Extremity Functional Scale (LEFS).

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Vascular surgery department, Ambroise Paré Hospital, APHP

Boulogne-Billancourt, Hauts-de-Seine, 92100, France

About this study

This is a prospective, single-center, non-interventional study conducted in the vascular surgery department of Ambroise Paré Hospital (AP-HP). Adult patients undergoing surgical management for FPAES are enrolled prospectively over a 24-month inclusion period (target: 138 patients) and followed for 36 months. Eligible patients are identified at the pre-operative consultation. Demographic, surgical, and clinical data are collected from the medical record at follow-up visits (M1, M3, M6, M12, M24, M36). The primary outcome is the rate of re-hospitalization within 30 days of surgery; post-operative adverse events (hematoma, surgical-site infection, deep vein thrombosis, and re-hospitalization) are recorded through day 30. Patient-reported lower-extremity function is assessed with the Lower Extremity Functional Scale (LEFS; validated French version), self-completed on paper the day before surgery and again at 6 months. Statistical analyses will be performed in R: the 30-day re-hospitalization proportion will be estimated with its 95% confidence interval (Wilson method), risk factors will be examined by univariate then multivariate logistic regression, and the change in LEFS impairment categories between baseline and 6 months will be compared using a test for paired data.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adults aged 18 years or older.
  • Patients with documented functional popliteal artery entrapment syndrome (FPAES).
  • Patients undergoing surgical management of FPAES in the vascular surgery department of Ambroise Paré Hospital (AP-HP).
  • Having received the information note and not having expressed opposition to participation in the study.

Exclusion criteria

  • Anatomical popliteal artery entrapment syndrome.
  • Patient refusal.
  • Inability to understand the proposed research and/or to express non-opposition.

Treatment and study plan

Primary outcomes

  1. Rate of re-hospitalization within 30 days after surgery

    Time frame: at 30 days

    The primary endpoint is the proportion of patients re-hospitalized for any cause within the 30 days following the surgical procedure.

Secondary outcomes

  1. Demographic data, surgery-related data, and associated medical and surgical history associated with re-hospitalization within 30 days post-surgery.

    Time frame: at 30 days

  2. Change in patient-reported lower-extremity function and impairment category, assessed with the Lower Extremity Functional Scale

    Time frame: at baseline and 6 months

    Use scale (LEFS; validated French version)

  3. Clinical evolution

    Time frame: at Month 1, Month 3, Mounth 6, Mmonth 12, Month 24 and Month36

    Clinical evolution and improvement during follow-up

  4. Return to sporting activities

    Time frame: at Month 1, Month 3, Mounth 6, Mmonth 12, Month 24 and Month36

    Return to sporting activity during follow-up

Study contacts

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

Mohammad Zagzoog, MD

CONTACT

[email protected]

+33 06 22 03 87 32

Raphaël COSCAS, MD, PhD

CONTACT

[email protected]

01 49 09 55 85

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Acronym: SAPP-F

Important dates

Study start
2026
Primary completion
2028
Study completion
2031
First posted
Aug 29, 2025
Registry last updated
Jun 10, 2026

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.

Published trials that share one or more normalized conditions with this study.