Acute Ischemia of Lower LimbDEVENIR-IAMNCT05255640
OUTCOME OF PATIENTS ADMITTED WITH ACUTE LOWER EXTREMITY ISCHEMIA
An observational study of Acute Ischemia of Lower Limb, run by Centre Hospitalier Universitaire de Nice at 14 sites in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemia of Lower Limb
- What is being tested?
- operation of ischemia of the lower limbs
- Type of treatment
- Surgery or procedure
- How many people
- 176 participants
- Where
- 14 sitesFrance
- Study dates
- 4 Mar 2022to 9 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with lower limb ischemia
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
France14 sites
Besançon university hospital
Besançon
Bordeaux University Hospital
Bordeaux
Brest University Hospital
Brest
Dijon University Hospital
Dijon
Lyon University Hospital
Lyon
Nancu University Hospital
Nancy
Nantes University Hospital
Nantes
Nice University Hospital
Nice, 06000
APHP - Hôpital Mondor
Paris
APHP- Ambroise Paré
Paris
APHP- Hôpital Bichat
Paris
APHP- Hôpital Européen Georges Pompidou
Paris
Reims University Hospital
Reims
Strasbourg University Hospital
Strasbourg
About this study
Official title: 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.
- Conditions
- Acute Ischemia of Lower Limb
- Being tested
- operation of ischemia of the lower limbs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
operation of ischemia of the lower limbsProcedure or surgery
The intervention technique is left to the judgment of the investigator to treat the ischemia
| Study group | Role | What they receive |
|---|---|---|
| patients with ischemia of the lower limbs | Not described Receives: Procedure: operation of ischemia of the lower limbs |
What is being measured
The primary outcome is the main question the study is designed to answer.
survival
Measured: 30 days
survival
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2022
- Study start4 Mar 2022
- Primary completion9 Nov 2023
- Study completion9 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemia of Lower LimbStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05255640
- Sponsor's protocol ID
- 21-PP-27
- Acronym
- DEVENIR-IAM
- Status last verified
- Jun 2024
- First submitted
- 15 Feb 2022
- Last updated
- 27 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MULTICENTER OBSERVATIONAL STUDY OF THE OUTCOME OF PATIENTS ADMITTED WITH ACUTE LOWER EXTREMITY ISCHEMIA
- ClinicalTrials.gov ID
- NCT05255640
- Acronym / sponsor ID
- DEVENIR-IAM / 21-PP-27
- Conditions
- Acute Ischemia of Lower Limb
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 4 Mar 2022 (actual)
- Primary completion
- 9 Nov 2023 (actual)
- Study completion
- 9 Nov 2023 (actual)
- First posted
- 24 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with ischemia of the lower limbs | – | Procedure: operation of ischemia of the lower limbs |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with lower limb ischemia
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| operation of ischemia of the lower limbsThe intervention technique is left to the judgment of the investigator to treat the ischemia | Procedure or surgery | patients with ischemia of the lower limbs |
Primary outcome
survival
Time frame: 30 days
survival
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Ischemia of Lower Limb, run by Centre Hospitalier Universitaire de Nice at 14 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
survival (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2024.