Histological and Imaging Assessment of the Structural Characteristics of the Femoro-popliteal Arterial Segment

The femoro-popliteal arterial segment is one of the most frequent locations for atherosclerosis. Its management is mainly endovascular (standard and coated-balloon angioplasty, stenting).

However, the structural features of the atherosclerotic disease in regards to patient's risk factors and past medical and surgical histories are not well studied. Furthermore, the histological analysis of the femoro-popliteal arterial segment is rare in the literature, and made difficult mostly because of the length of this segment.

There is a clinical need for better understanding of atherosclerotic lesions in this location, with as further goal, a better management of this disease.

Study Overview

• Status: Unknown
• Conditions: Chronic Limb Ischemia
• Intervention / Treatment: Procedure: Explantation of the femoro-popliteal arterial segment from the amputed limb

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: Nabil CHAKFE; Phone Number: +33 3 69 55 08 88; Email: nabil.chakfe@chru-strasbourg.fr

Study Locations

• France
  • Strasbourg, France, 67091
    • Les Hôpitaux Universitaires de Strasbourg
    • Contact: Nabil CHAKFE; Phone Number: + 33 3 69 55 08 88; Email: nabil.chakfe@chru-strasbourg.fr
    • Sub-Investigator: Anne LEJAY
    • Sub-Investigator: Yannick GEORG

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with chronic limb ischemia that are scheduled for transfemoral amputation

Description

Inclusion criteria:

• Age > 18 years old
• Men and women
• Patient with chronic limb ischemia that is scheduled for transfemoral amputation in the University Hospital of Strasbourg
• Patient giving his -non-opposition to the explantation and use of the femoro-popliteal arterial segment

Exclusion criteria:

• Refusal to give his consent
• Impossibility to give clear information to the patient
• Pregnant and breastfeeding women
• Patient under administrative protection

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Descriptive analysis of the arterial structure in micro-CT.	study precisely the pathological structure of the femoro-popliteal arterial segment in AOMI, both in imaging and histologically.	3 years

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France
• Investigators: Principal Investigator: Nabil CHAKFE, Les Hôpitaux Universitaires de Strasbourg

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): April 1, 2019
• Primary Completion (ANTICIPATED): April 1, 2019
• Study Completion (ANTICIPATED): February 1, 2022

Study Registration Dates

• First Submitted: December 18, 2018
• First Submitted That Met QC Criteria: February 18, 2019
• First Posted (ACTUAL): February 20, 2019

Study Record Updates

• Last Update Posted (ACTUAL): March 26, 2019
• Last Update Submitted That Met QC Criteria: March 25, 2019
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Ischemia
• Other Study ID Numbers: 7168

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No