Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2025-12-25 @ 9:17 PM
Study NCT ID:
NCT07147556
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-08
First Post:
2025-08-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Surgical Treatment of Functional Popliteal Artery Entrapment Syndrome: Results of a Systematic Approach Based on the Section of the Medial Gastrocnemius Attachment
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Study Overview
Official Title:
Surgical Treatment of Functional Popliteal Artery Entrapment Syndrome: Results of a Systematic Approach Based on the Section of the Medial Gastrocnemius Attachment
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SAPP-F
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.
Detailed Description:
This study is a single-center retrospective study of all patients who underwent surgical treatment of FPAES between 2015 and 2025 by 2 vascular surgeons. Patients will be identified via hospital database and data collection including patients' demographics, clinical presentation, length of hospitalisation, participation in sport, diagnostic workup, procedural details and complications, clinical improvement, and postoperative imaging were prospectively collected from a dedicated institutional database. To evaluate objectively the functional improvement as well as to assess the effectiveness of the surgical intervention, the Lower Extremity Functional Scale (LEFS) was used post operatively at the time of conducting this study. The LEFS is a self-administered questionnaire, comprised of 20 items, to assess patient's ability to perform everyday tasks and has been used by clinicians as a measure of patients' lower extremity initial function, ongoing progress and outcome after surgical intervention as well as to evaluate the functional impairment of lower extremities.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2025-A01670-49 | REGISTRY | IDRCB | View |