NCT07147556

Brief Summary

Functional popliteal artery entrapment syndrome (FPAES) is a rare unique clinical entity that does not have associated with anatomic abnormalities and, therefore, is thought to be functional in nature (1,2). It has been first described by Rignault et al. in 1985, and its true mechanism is not well understood (3,4). Given the relative lack of knowledge of FPAES in the literature and the reported outcomes after decompressive surgery are limited and not standardized. The objective of this study was to describe our diagnostic and peri-operative protocol, clinical outcomes of a unique surgical management technique based on the systemic section of the attachment of the medial head of the gastrocnemius.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
7mo left

Started Oct 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress51%
Oct 2025Dec 2026

First Submitted

Initial submission to the registry

August 22, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 29, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2025

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

September 8, 2025

Status Verified

September 1, 2025

Enrollment Period

1.1 years

First QC Date

August 22, 2025

Last Update Submit

September 1, 2025

Conditions

Keywords

Functional popliteal artery entrapment syndromeSurgical treatmentSystematic approachAthleteDecompression

Outcome Measures

Primary Outcomes (1)

  • To evaluate the clinical and functional improvement, and the return to the sportive level

    Clinical improvement was defined as the ability to increase activity or decreased discomfort of the initial presenting symptoms. To evaluate objectively the functional improvement as well as to assess the effectiveness of the surgical intervention, the Lower Extremity Functional Scale (LEFS) will be used post operatively at 1 year post operativeley

    at 1 year

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients who underwent surgical treatment of FPAES between 2015 and 2025

You may qualify if:

  • All patients who underwent surgical treatment of functional popliteal artery entrapment syndrome between 2015 and 2025 and agree to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • Singh N. Functional popliteal entrapment: A diagnostic and treatment conundrum. J Vasc Surg. 2019 Nov;70(5):1563. doi: 10.1016/j.jvs.2019.02.019. No abstract available.

    PMID: 31653376BACKGROUND
  • Hislop M, Kennedy D, Cramp B, Dhupelia S. Functional Popliteal Artery Entrapment Syndrome: Poorly Understood and Frequently Missed? A Review of Clinical Features, Appropriate Investigations, and Treatment Options. J Sports Med (Hindawi Publ Corp). 2014;2014:105953. doi: 10.1155/2014/105953. Epub 2014 Sep 7.

    PMID: 26464888BACKGROUND
  • Rignault DP, Pailler JL, Lunel F. The "functional" popliteal entrapment syndrome. Int Angiol. 1985 Jul-Sep;4(3):341-3.

    PMID: 3831156BACKGROUND
  • Turnipseed WD. Functional popliteal artery entrapment syndrome: A poorly understood and often missed diagnosis that is frequently mistreated. J Vasc Surg. 2009 May;49(5):1189-95. doi: 10.1016/j.jvs.2008.12.005.

    PMID: 19394547BACKGROUND
  • Binkley JM, Stratford PW, Lott SA, Riddle DL. The Lower Extremity Functional Scale (LEFS): scale development, measurement properties, and clinical application. North American Orthopaedic Rehabilitation Research Network. Phys Ther. 1999 Apr;79(4):371-83.

    PMID: 10201543BACKGROUND

MeSH Terms

Conditions

Popliteal Artery Entrapment Syndrome

Condition Hierarchy (Ancestors)

Arterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Raphaël COSCAS, MD, PhD

    CHU Ambroise Paré - APHP

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Raphaël COSCAS, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 22, 2025

First Posted

August 29, 2025

Study Start

October 1, 2025

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

September 8, 2025

Record last verified: 2025-09