OUTCOME OF PATIENTS ADMITTED WITH ACUTE LOWER EXTREMITY ISCHEMIA

Acute Ischemia of Lower Limb Clinical Trial

— DEVENIR-IAM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05255640
• Other study ID #: 21-PP-27
• Status: Recruiting
• Start date: March 4, 2022
• Est. completion date: February 21, 2025

Study information

• Verified date: February 2022
• Source: Centre Hospitalier Universitaire de Nice
• Contact: Juliette RAFFORT, PH
• Phone: 04 92 03 87 90
• Email: raffort-lareyre.j[@]chu-nice.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: February 21, 2025
• Est. primary completion date: June 21, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Ischemia of Lower Limb
• Ischemia

Intervention

Procedure:
• operation of ischemia of the lower limbs
The intervention technique is left to the judgment of the investigator to treat the ischemia

Locations

Country	Name	City	State
France	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
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

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	survival		30 days
Primary	survival		90 days