Histological and Imaging Assessment of the Structural Cha... | NCT03847597

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

NCT03847597

Sponsor

University Hospital, Strasbourg, France

Status

Unknown status

Last Update Posted

Mar 26, 2019Actual

Enrollment

50Estimated

Phase

Not provided

Conditions

Chronic Limb Ischemia

Interventions

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

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2019Estimated

Primary Completion Date

Apr 2019Estimated

Completion Date

Feb 2022Estimated

First Submitted Date

Dec 18, 2018

First Submission Date that Met QC Criteria

Feb 18, 2019

First Posted Date

Feb 20, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 25, 2019

Last Update Posted Date

Mar 26, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Explantation of the femoro-popliteal arterial segment from the amputed limb	Procedure	Explantation of the femoro-popliteal arterial segment from the amputed limb

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with chronic limb ischemia that are scheduled for transfemoral amputation

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Nabil CHAKFE	Contact	+33 3 69 55 08 88		nabil.chakfe@chru-strasbourg.fr

Overall Officials

Name	Affiliation	Role
Nabil CHAKFE	Les Hôpitaux Universitaires de Strasbourg	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Les Hôpitaux Universitaires de Strasbourg		Strasbourg		67091	France

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided