OUTCOME OF PATIENTS ADMITTED WITH ACUTE LOWER EXTREMITY ISCHEMIA (DEVENIR-IAM)

March 11, 2022 updated by: Centre Hospitalier Universitaire de Nice

MULTICENTER OBSERVATIONAL STUDY OF THE OUTCOME OF PATIENTS ADMITTED WITH ACUTE LOWER EXTREMITY ISCHEMIA

Acute ischemia of the lower limb (AMI) is a life-threatening emergency that threatens the functional prognosis of the limb. Depending on the clinical presentation and the anatomy of the patient, several therapeutic approaches can be considered: open surgery, endovascular surgery, hybrid surgery or amputation if revascularization is not feasible. The data in the current literature do not allow to clearly establish which therapeutic approach is the most adapted to the patient.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Besançon, France
        • Not yet recruiting
        • Besançon University Hospital
        • Principal Investigator:
          • Lucie Salomon Du Mont
        • Contact:
      • Bordeaux, France
        • Not yet recruiting
        • Bordeaux University Hospital
        • Contact:
        • Principal Investigator:
          • Caroline Caradu
      • Brest, France
        • Not yet recruiting
        • Brest University Hospital
        • Contact:
        • Principal Investigator:
          • Bahaa Nasr
      • Dijon, France
        • Not yet recruiting
        • Dijon University Hospital
        • Contact:
        • Principal Investigator:
          • Eric Steinmetz
      • Lyon, France
        • Not yet recruiting
        • Lyon university hospital
        • Contact:
        • Principal Investigator:
          • Antoine Millon
      • Nancy, France
        • Not yet recruiting
        • Nancu University Hospital
        • Contact:
        • Principal Investigator:
          • Nicla Settembre
      • Nantes, France
        • Not yet recruiting
        • Nantes University Hospital
        • Contact:
        • Principal Investigator:
          • Blandine Maurel
      • Nice, France, 06000
        • Recruiting
        • Nice University Hospital
        • Contact:
        • Sub-Investigator:
          • Elixene Jean-Baptiste
        • Principal Investigator:
          • Juliette Raffort-Lareyre
      • Paris, France
        • Not yet recruiting
        • APHP - Hôpital Mondor
        • Contact:
        • Principal Investigator:
          • Joseph Touma
      • Paris, France
        • Not yet recruiting
        • APHP- Ambroise Paré
        • Contact:
        • Principal Investigator:
          • Raphael Coscas
      • Paris, France
        • Not yet recruiting
        • APHP- Hopital BICHAT
        • Contact:
        • Principal Investigator:
          • Jean Sénémaud
      • Paris, France
        • Not yet recruiting
        • APHP- Hôpital Européen Georges Pompidou
        • Contact:
        • Principal Investigator:
          • Jean-Marc Alsac
      • Reims, France
        • Recruiting
        • Reims university Hospital
        • Contact:
        • Principal Investigator:
          • Ambroise Duprey
      • Strasbourg, France
        • Not yet recruiting
        • Strasbourg University Hospital
        • Contact:
        • Principal Investigator:
          • Adeline Schwein

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 lower limb ischemia

Description

Inclusion Criteria:

  • Age greater than 18 years, regardless of gender.
  • Diagnosis of AMI defined according to the Rutherford classification (2). AMI may involve one or both lower limbs.
  • Be able to understand and give free and informed consent (non-opposition) to participate in the study
  • To be affiliated to the social security system
  • Not to object to participating in the study (collection of non-objection)

Exclusion Criteria:

  • Voluntary discharge of the patient: opposition to the use of the data (withdrawal of the non-objection)
  • Termination of the study by decision of the sponsor or investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
patients with ischemia of the lower limbs
Procedure: operation of ischemia of the lower limbs
The intervention technique is left to the judgment of the investigator to treat the ischemia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
survival
Time Frame: 30 days
30 days
survival
Time Frame: 90 days
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nice

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 4, 2022

Primary Completion (Anticipated)

June 21, 2022

Study Completion (Anticipated)

February 21, 2025

Study Registration Dates

First Submitted

February 15, 2022

First Submitted That Met QC Criteria

February 15, 2022

First Posted (Actual)

February 24, 2022

Study Record Updates

Last Update Posted (Actual)

March 14, 2022

Last Update Submitted That Met QC Criteria

March 11, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-PP-27

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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