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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07147556
Acronym
SAPP-F
Enrollment
138
Registered
2025-08-29
Start date
2026-06-10
Completion date
2031-06-01
Last updated
2026-06-10

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

Conditions

Popliteal Artery Entrapment Syndrome

Keywords

Functional popliteal artery entrapment syndrome, Surgical treatment, Systematic approach, Athlete, Decompression

Brief summary

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).

Detailed description

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.

Interventions

None listed

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Rate of re-hospitalization within 30 days after surgeryat 30 daysThe primary endpoint is the proportion of patients re-hospitalized for any cause within the 30 days following the surgical procedure.

Secondary

MeasureTime frameDescription
Demographic data, surgery-related data, and associated medical and surgical history associated with re-hospitalization within 30 days post-surgery.at 30 days
Change in patient-reported lower-extremity function and impairment category, assessed with the Lower Extremity Functional Scaleat baseline and 6 monthsUse scale (LEFS; validated French version)
Clinical evolutionat Month 1, Month 3, Mounth 6, Mmonth 12, Month 24 and Month36Clinical evolution and improvement during follow-up
Return to sporting activitiesat Month 1, Month 3, Mounth 6, Mmonth 12, Month 24 and Month36Return to sporting activity during follow-up

Countries

France

Contacts

CONTACTRaphaël COSCAS, MD, PhD
raphael.coscas@aphp.fr01 49 09 55 85
CONTACTMohammad Zagzoog, MD
mohammadmzagzoog@gmail.com+33 06 22 03 87 32
PRINCIPAL_INVESTIGATORRaphaël COSCAS, MD, PhD

CHU Ambroise Paré - APHP

STUDY_DIRECTORMohammad Zagzoog, MD

Hôpital Marie Lannelongue, France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 11, 2026