OUTCOME OF PATIENTS ADMITTED WITH ACUTE LOWER EXTREMITY ISCHEMIA
DEVENIR-IAM
MULTICENTER OBSERVATIONAL STUDY OF THE OUTCOME OF PATIENTS ADMITTED WITH ACUTE LOWER EXTREMITY ISCHEMIA
1 other identifier
observational
176
1 country
14
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2022
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 15, 2022
CompletedFirst Posted
Study publicly available on registry
February 24, 2022
CompletedStudy Start
First participant enrolled
March 4, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 9, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 9, 2023
CompletedJune 27, 2024
June 1, 2024
1.7 years
February 15, 2022
June 26, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
survival
30 days
survival
90 days
Study Arms (1)
patients with ischemia of the lower limbs
Interventions
The intervention technique is left to the judgment of the investigator to treat the ischemia
Eligibility Criteria
patients with lower limb ischemia
You may qualify if:
- 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)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
Besançon university hospital
Besançon, France
Bordeaux University Hospital
Bordeaux, France
Brest University Hospital
Brest, France
Dijon University Hospital
Dijon, France
Lyon University Hospital
Lyon, France
Nancu University Hospital
Nancy, France
Nantes University Hospital
Nantes, France
Nice University Hospital
Nice, 06000, France
APHP - Hôpital Mondor
Paris, France
APHP- Ambroise Paré
Paris, France
APHP- Hôpital Bichat
Paris, France
APHP- Hôpital Européen Georges Pompidou
Paris, France
Reims University Hospital
Reims, France
Strasbourg University Hospital
Strasbourg, France
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 15, 2022
First Posted
February 24, 2022
Study Start
March 4, 2022
Primary Completion
November 9, 2023
Study Completion
November 9, 2023
Last Updated
June 27, 2024
Record last verified: 2024-06
Data Sharing
- IPD Sharing
- Will not share