Popliteal Artery Entrapment SyndromeSAPP-FNCT07147556
Surgical Treatment of Functional Popliteal Artery Entrapment Syndrome: Short- and Mid-Term Results
An observational study of Popliteal Artery Entrapment Syndrome, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Popliteal Artery Entrapment Syndrome
- How many people
- 138 participants
- Where
- 1 siteFrance
- Study dates
- 10 Jun 2026to Jun 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adult patients undergoing surgical management for functional popliteal artery entrapment syndrome (FPAES) in the vascular surgery department of Ambroise Paré Hospital (AP-HP) during the 24-month inclusion period (target: 138 patients).
Who may be able to join
- 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.
Who cannot join
- Anatomical popliteal artery entrapment syndrome.
- Patient refusal.
- Inability to understand the proposed research and/or to express non-opposition.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Vascular surgery department, Ambroise Paré Hospital, APHP
Boulogne-Billancourt, Hauts-de-Seine, 92100
About this study
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).
Read the 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.
- Conditions
- Popliteal Artery Entrapment Syndrome
- Keywords
- Functional popliteal artery entrapment syndrome, Surgical treatment, Systematic approach, Athlete, Decompression
- Medical subject headings
- Popliteal Artery Entrapment Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of re-hospitalization within 30 days after surgery
The primary endpoint is the proportion of patients re-hospitalized for any cause within the 30 days following the surgical procedure.
Measured: at 30 days
Secondary outcomes (4)
Demographic data, surgery-related data, and associated medical and surgical history associated with re-hospitalization within 30 days post-surgery.
Measured: at 30 days
Change in patient-reported lower-extremity function and impairment category, assessed with the Lower Extremity Functional Scale
Use scale (LEFS; validated French version)
Measured: at baseline and 6 months
Clinical evolution
Clinical evolution and improvement during follow-up
Measured: at Month 1, Month 3, Mounth 6, Mmonth 12, Month 24 and Month36
Return to sporting activities
Return to sporting activity during follow-up
Measured: at Month 1, Month 3, Mounth 6, Mmonth 12, Month 24 and Month36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2025
- Study start10 Jun 2026 (estimated)
- Primary completion9 Jun 2028 (estimated)
- Study completionJun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Popliteal Artery Entrapment SyndromeStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Raphaël COSCAS, MD, PhD, Principal investigator, CHU Ambroise Paré - APHPMohammad Zagzoog, MD, Study director, Hôpital Marie Lannelongue, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07147556
- Sponsor's protocol ID
- APHP251098
- Other IDs
- 2026-A00402-49
- Acronym
- SAPP-F
- Status last verified
- Jun 2026
- First submitted
- 22 Aug 2025
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 31653376Hislop 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.
PubMed 26464888Rignault DP, Pailler JL, Lunel F. The "functional" popliteal entrapment syndrome. Int Angiol. 1985 Jul-Sep;4(3):341-3.
PubMed 3831156Turnipseed 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.
PubMed 19394547Binkley 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.
PubMed 10201543
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Treatment of Functional Popliteal Artery Entrapment Syndrome: Short- and Mid-Term Results
- ClinicalTrials.gov ID
- NCT07147556
- Acronym / sponsor ID
- SAPP-F / APHP251098
- Conditions
- Popliteal Artery Entrapment Syndrome
- Keywords
- Functional popliteal artery entrapment syndrome, Surgical treatment, Systematic approach, Athlete, Decompression
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 10 Jun 2026 (estimated)
- Primary completion
- 9 Jun 2028 (estimated)
- Study completion
- Jun 2031 (estimated)
- First posted
- 29 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients undergoing surgical management for functional popliteal artery entrapment syndrome (FPAES) in the vascular surgery department of Ambroise Paré Hospital (AP-HP) during the 24-month inclusion period (target: 138 patients).
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Anatomical popliteal artery entrapment syndrome.
- Patient refusal.
- Inability to understand the proposed research and/or to express non-opposition.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
4 secondary outcomes
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
Change in patient-reported lower-extremity function and impairment category, assessed with the Lower Extremity Functional Scale
Time frame: at baseline and 6 months
Clinical evolution
Time frame: at Month 1, Month 3, Mounth 6, Mmonth 12, Month 24 and Month36
Return to sporting activities
Time frame: at Month 1, Month 3, Mounth 6, Mmonth 12, Month 24 and Month36
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Background: PubMed 31653376Singh 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.
- Background: PubMed 26464888Hislop 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.
- Background: PubMed 3831156Rignault DP, Pailler JL, Lunel F. The "functional" popliteal entrapment syndrome. Int Angiol. 1985 Jul-Sep;4(3):341-3.
- Background: PubMed 19394547Turnipseed 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.
- Background: PubMed 10201543Binkley 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.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Raphaël COSCAS, MD, PhD principal investigator
CHU Ambroise Paré - APHP
Mohammad Zagzoog, MD study director
Hôpital Marie Lannelongue, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Popliteal Artery Entrapment Syndrome, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Raphaël COSCAS, MD, PhD (01 49 09 55 85, raphael.coscas@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of re-hospitalization within 30 days after surgery (time frame: at 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07147556, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.