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

NCT03847597 | Unknown

• 1 other identifier: 7168
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Limb Ischemia

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Explantation of the femoro-popliteal arterial segment from the amputed limb PROCEDURE

Explantation of the femoro-popliteal arterial segment from the amputed limb

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with chronic limb ischemia that are scheduled for transfemoral amputation

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Les Hôpitaux Universitaires de Strasbourg

Strasbourg, 67091, France

Location

Study Officials

• Nabil CHAKFE

  Les Hôpitaux Universitaires de Strasbourg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nabil CHAKFE

CONTACT

+33 3 69 55 08 88; nabil.chakfe@chru-strasbourg.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2018
• First Posted: February 20, 2019
• Study Start: April 1, 2019
• Primary Completion: April 1, 2019
• Study Completion: February 1, 2022
• Last Updated: March 26, 2019

Record last verified: 2018-12

Locations

FR (1)