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

Chronic Limb Ischemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03847597
• Other study ID #: 7168
• Status: Not yet recruiting
• Start date: April 2019
• Est. completion date: February 2022

Study information

• Verified date: December 2018
• Source: University Hospital, Strasbourg, France
• Contact: Nabil CHAKFE
• Phone: +33 3 69 55 08 88
• Email: nabil.chakfe[@]chru-strasbourg.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: February 2022
• Est. primary completion date: April 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Limb Ischemia
• Ischemia

Intervention

Procedure:
• Explantation of the femoro-popliteal arterial segment from the amputed limb
Explantation of the femoro-popliteal arterial segment from the amputed limb

Locations

Country	Name	City	State
France	Les Hôpitaux Universitaires de Strasbourg	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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