Acute Limb IschemiaPROMOTE-ALINCT05138679
Evaluation of Acute Lower Limb Ischemia
An observational study of Acute Limb Ischemia, run by Medical University Innsbruck at 37 sites in 10 countries.
Trial summary
The primary objective of this study is to evaluate the effect of different treatment modalities on clinical outcome of patients suffering from acute lower limb ischemia (ALI). Depending on clinical presentation, anatomical as well as technical considerations, different treatment options are available for… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Limb Ischemia
- What is being tested?
- Revascularization, Primary major amputation and Best medical treatment
- Type of treatment
- Surgery or procedure
- How many people
- 700 participants
- Where
- 37 sitesin 10 countries
- Study dates
- 1 Dec 2021to 31 Aug 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: All patients with the diagnosis of acute lower limb ischemia treated at a participating study center.
Who may be able to join
- Acute lower limb ischemia (Rutherford Categories I-III)
Who cannot join
- No informed consent
Trial locations and contacts
37 sites in 10 countries.
37 sites in 10 countries
France15 sites
Department of Vascular Surgery, Hospital of Antibes Juan-les-Pins
Antibes
Department of Vascular Surgery, Bordeaux University Hospital
Bordeaux
Department of Vascular Surgery, Ambroise Paré University Hospital, Assistance Publique-Hôpitaux de Paris
Boulogne-Billancourt, 92100
Department of Vascular and Endovascular Surgery, Brest University Hospital
Brest
Department of Vascular Surgery, Henri Mondor University Hospital
Créteil
Department of Vascular Surgery, University Hospital of Dijon
Dijon
Vascular Surgery Department, Hospices Civils de Lyon
Lyon
Department of Vascular Surgery, University Hospital of Nancy
Nancy
CHU Nantes, l'institut du thorax, service de chirurgie cardio-vasculaire
Nantes
University Hospital of Nice, Université Côte d'Azur
Nice
Department of Vascular and Thoracic Surgery, Bichat Hospital, Paris, Université de Paris
Paris
Department of Vascular Surgery, Ambroise Paré University Hospital, Boulogne-Billancourt and Simone Veil Health Sciences Medical School, Versailles-Saint-Quentin-en-Yvelines University and Paris-Saclay University
Paris
Vascular Surgery Department, Georges Pompidou European Hospital, APHP, Paris University
Paris
Department of Vascular Surgery, CHU de Reims
Reims
Department of Vascular Surgery and Kidney Transplantation, University Hospitals of Strasbourg
Strasbourg
Germany5 sites
European Vascular Center Aachen-Maastricht, University Hospital Aachen, RWTH Aachen University
Aachen
University Hospital Cologne
Cologne
Division of Vascular and Endovascular Surgery Department for Visceral-, Thoracic and Vascular Surgery Medical Faculty Carl Gustav Carus and University Hospital Carl Gustav Carus Dresden Technische Universität Dresden
Dresden
Department of Vascular- and Endovascular Surgery, Medical Faculty and University Hospital Düsseldorf, Heinrich-Heine-University Düsseldorf
Düsseldorf
Department of Vascular and Endovascular Surgery, University Hospital Münster
Münster
Austria4 sites
Medical University of Innsbruck, Department of Vascular Surgery
Innsbruck, 6020
Department of General Surgery, Division of Vascular Surgery, Medical University of Vienna
Vienna, 1090
Department of Vascular and Endovascular Surgery, Hospital Ottakring
Vienna, 1160
Department of Cardio-Vascular Surgery, Clinic Floridsdorf and Karl Landsteiner Institute for Cardio-Vascular Research
Vienna, 1210
Serbia3 sites
Clinic for Vascular and Endovascular Surgery, Clinical Center of Serbia
Belgrade
Institute for Cardiovascular Disease, Belgrade
Belgrade
Clinic for Vascular Surgery, Clinical Center Niš
Niš
United Kingdom3 sites
Bristol Centre for Surgical Research, Bristol NIHR Biomedical Research Centre, University of Bristol
Bristol
Department of Vascular Surgery, University Hospital Wales
Cardiff
NHS Lothian
Edinburgh, EH1 3EG
Netherlands2 sites
Amsterdam University Medical Center, Department of Surgery
Amsterdam, 1105 AZ
University Medical Center Utrecht, Department of Vascular Surgery
Utrecht, 3584 CX
Switzerland2 sites
Department of Cardiovascular Surgery, Inselspital, University of Bern
Bern, 3010
Department of Vascular Surgery, Kantonsspital Winterthur
Winterthur
Hungary1 site
Department of Vascular and Endovascular Surgery, Heart and Vascular Center, Semmelweis University
Budapest
About this study
Official title: Prospective Multicenter Observational Study Evaluating Acute Lower Limb Ischemia
The primary objective of this study is to evaluate the effect of different treatment modalities on clinical outcome of patients suffering from acute lower limb ischemia (ALI). Depending on clinical presentation, anatomical as well as technical considerations, different treatment options are available for revascularisation of affected limbs. Using an observational, international, multicentric study design (min. patient number of 500), the defined primary endpoint of the study, amputation-free survival 90 days after the diagnosis of ALI, will be evaluated.
Read the detailed description
Recently published clinical guidelines highlighted that the available evidence on the management of acute lower limb ischemia (ALI) is mostly outdated and includes only small patient cohorts. Depending on the patient's characteristics, the duration of ischemic symptoms as well as the cause of ALI and the anatomical lesion, different treatment options are available and need to be compared regarding clinical outcome.
With the knowledge about the heterogeneity of patients suffering from ALI, a multicentre observational study design has the potential to give results on influence of several factors (patient related factors, treatment related factors) on clinical outcome of patients with lower extremity ALI. In contrast, a randomized controlled trial would not be feasible as heterogeneity of patients would lead to limitations in the recruitment of patients.
The primary objective of this study is to evaluate the effect of different treatment modalities on clinical outcome of patients suffering from acutle lower limb ischemia. Depending on clinical presentation, anatomical as well as technical considerations, different treatment options are available for revascularisation of affected limbs. Using an observational, international, multicentric study design (min. patient number of 500), the defined primary endpoint of the study, amputation-free survival 90 days after the diagnosis of ALI, will be evaluated.
The secondary objectives of this study are the identification of factors having an effect on the primary endpoint . These factors are:
- Demographic data (age, gender, Body Mass Index,
- Cardiovascular risk factors (diabetes, arterial hypertension, dyslipidemia, smoking history)
- COVID-19 anamnesis (infectious status; vaccination status)
- Pre-existing diseases (Arterial fibrillation, chronic kidney disease, hemodialysis, coronary artery disease, COVID infection in medical history, pulmonary disease)
- Risk factors for ALI (peripheral arterial disease, aortic aneurysm or dissection, arterial embolization in medical history, malignant disease, peripheral arterial aneurysm, previous stroke, thrombophilia, revascularization procedure on ipsilateral limb)
- Pre-existing medication (antiplatelet, oral anticoagulation, statins)
- Clinical presentation (Rutherford ischemia classification, Cause of ALI, anatomical level of arterial occlusion, diagnostic imaging modality)
- Details on performed intervention (time of ischemia, periprocedural heparin administration, type of procedure, technical details on performed procedure, compartment syndrome with need for fasciotomy)
- Outcome parameters (Survival, Rutherford ischemia classification, residual sensory or motor deficit, impaired walking distance, need for reintervention, major bleeding periprocedural, access site complications, organ failure) 30 and 90 days after diagnosis of ALI.
- Conditions
- Acute Limb Ischemia
- Being tested
- Revascularization, Primary major amputation, Best medical treatment
- Keywords
- acute lower limb ischemia, revascularization, compartment syndrome, limb salvage, COVID-19
- Medical subject headings
- Compartment Syndromes, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RevascularizationProcedure or surgery
Also called Surgical embolectomy, Peripheral bypass, Catheter directed thrombolysis, Catheter guided aspiration
Endovascular or surgical restoration of arterial blood flow.
Primary major amputationProcedure or surgery
Primary below- or above knee major amputation without prior revascularization.
Best medical treatmentOther
Conservative treatment of acute lower limb ischemia - without prior revascularization.
| Study group | Role | What they receive |
|---|---|---|
| Acute lower limb ischemia | Patients with acute lower limb ischemia (older than 18 years) Receives: Procedure: Revascularization; Procedure: Primary major amputation; Other: Best medical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amputation free survival - rate
Rate of amputation free survival after diagnosis of acute lower limb ischemia
Measured: 90 days
Secondary outcomes (5)
Re-intervention rate of the index leg
Rate of re-intervention for revascularization or complications of the index-leg
Measured: 90 days
Complication rate
Rate of complications after the diagnosis of acute limb ischemia (access site infection, acute kidney injury, periprocedural major bleeding, compartment syndrome, multi organ failure)
Measured: 90 days
Limb salvage rate
Rate of patients not requiring major amputation.
Measured: 90 days
Survival rate
Rate of patients surviving the diagnosis of acute limb ischemia until the end of follow-up
Measured: 90 days
Clinical outcome of the index leg (Rutherford category)
Clinical symptoms at the end of follow up (Rutherford category)
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 posted1 Dec 2021
- Study start1 Dec 2021
- Primary completion31 May 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Acute Limb IschemiaStudies of the same condition, open and under way.
- More trials run by Medical University InnsbruckThe 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
- 700 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University Innsbruck
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Florian K Enzmann, MD, PhD, Principal investigator, Department of Vascular Surgery, Medical University of InnsbruckAlexandra Gratl, MD, Principal investigator, Department of Vascular Surgery, Medical University of Innsbruck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05138679
- Sponsor's protocol ID
- 1220/2021
- Acronym
- PROMOTE-ALI
- Status last verified
- Aug 2021
- First submitted
- 15 Nov 2021
- Last updated
- 31 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Behrendt CA, Bjorck M, Schwaneberg T, Debus ES, Cronenwett J, Sigvant B; Acute Limb Ischaemia Collaborators. Editor's Choice - Recommendations for Registry Data Collection for Revascularisations of Acute Limb Ischaemia: A Delphi Consensus from the International Consortium of Vascular Registries. Eur J Vasc Endovasc Surg. 2019 Jun;57(6):816-821. doi: 10.1016/j.ejvs.2019.02.023. Epub 2019 May 22.
PubMed 31128987Bjorck M, Earnshaw JJ, Acosta S, Bastos Goncalves F, Cochennec F, Debus ES, Hinchliffe R, Jongkind V, Koelemay MJW, Menyhei G, Svetlikov AV, Tshomba Y, Van Den Berg JC, Esvs Guidelines Committee, de Borst GJ, Chakfe N, Kakkos SK, Koncar I, Lindholt JS, Tulamo R, Vega de Ceniga M, Vermassen F, Document Reviewers, Boyle JR, Mani K, Azuma N, Choke ETC, Cohnert TU, Fitridge RA, Forbes TL, Hamady MS, Munoz A, Muller-Hulsbeck S, Rai K. Editor's Choice - European Society for Vascular Surgery (ESVS) 2020 Clinical Practice Guidelines on the Management of Acute Limb Ischaemia. Eur J Vasc Endovasc Surg. 2020 Feb;59(2):173-218. doi: 10.1016/j.ejvs.2019.09.006. Epub 2019 Dec 31. No abstract available.
PubMed 31899099Doukas P, Enzmann FK, Noronen K, Tran L, Busch A, Zlatanovic P, Predenciuc A, Raffort J, Gratl A, Caradu C; EVRC Collaborative. Insights from the prospective multicentre observational study evaluating acute lower limb ischemia on the influence of patient characteristics on treatment strategy selection and outcomes. J Vasc Surg. 2025 Sep;82(3):987-997.e5. doi: 10.1016/j.jvs.2025.03.476. Epub 2025 Apr 7.
PubMed 40204031Gratl A; European Vascular Research Collaborative (EVRC). Study Protocol of a Prospective Multicenter Observational Study Evaluating Acute Lower Limb Ischemia. J Surg Res. 2023 Feb;282:280-284. doi: 10.1016/j.jss.2022.09.023. Epub 2022 Nov 5.
PubMed 36347128
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multicenter Observational Study Evaluating Acute Lower Limb Ischemia
- ClinicalTrials.gov ID
- NCT05138679
- Acronym / sponsor ID
- PROMOTE-ALI / 1220/2021
- Conditions
- Acute Limb Ischemia
- Keywords
- acute lower limb ischemia, revascularization, compartment syndrome, limb salvage, COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 700 participants (actual)
- Lead sponsor
- Medical University InnsbruckUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 1 Dec 2021 (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.
The primary objective of this study is to evaluate the effect of different treatment modalities on clinical outcome of patients suffering from acute lower limb ischemia (ALI). Depending on clinical presentation, anatomical as well as technical considerations, different treatment options are available for revascularisation of affected limbs. Using an observational, international, multicentric study design (min. patient number of 500), the defined primary endpoint of the study, amputation-free survival 90 days after the diagnosis of ALI, will be evaluated.
Detailed description
Recently published clinical guidelines highlighted that the available evidence on the management of acute lower limb ischemia (ALI) is mostly outdated and includes only small patient cohorts. Depending on the patient's characteristics, the duration of ischemic symptoms as well as the cause of ALI and the anatomical lesion, different treatment options are available and need to be compared regarding clinical outcome.
With the knowledge about the heterogeneity of patients suffering from ALI, a multicentre observational study design has the potential to give results on influence of several factors (patient related factors, treatment related factors) on clinical outcome of patients with lower extremity ALI. In contrast, a randomized controlled trial would not be feasible as heterogeneity of patients would lead to limitations in the recruitment of patients.
The primary objective of this study is to evaluate the effect of different treatment modalities on clinical outcome of patients suffering from acutle lower limb ischemia. Depending on clinical presentation, anatomical as well as technical considerations, different treatment options are available for revascularisation of affected limbs. Using an observational, international, multicentric study design (min. patient number of 500), the defined primary endpoint of the study, amputation-free survival 90 days after the diagnosis of ALI, will be evaluated.
The secondary objectives of this study are the identification of factors having an effect on the primary endpoint . These factors are:
- Demographic data (age, gender, Body Mass Index,
- Cardiovascular risk factors (diabetes, arterial hypertension, dyslipidemia, smoking history)
- COVID-19 anamnesis (infectious status; vaccination status)
- Pre-existing diseases (Arterial fibrillation, chronic kidney disease, hemodialysis, coronary artery disease, COVID infection in medical history, pulmonary disease)
- Risk factors for ALI (peripheral arterial disease, aortic aneurysm or dissection, arterial embolization in medical history, malignant disease, peripheral arterial aneurysm, previous stroke, thrombophilia, revascularization procedure on ipsilateral limb)
- Pre-existing medication (antiplatelet, oral anticoagulation, statins)
- Clinical presentation (Rutherford ischemia classification, Cause of ALI, anatomical level of arterial occlusion, diagnostic imaging modality)
- Details on performed intervention (time of ischemia, periprocedural heparin administration, type of procedure, technical details on performed procedure, compartment syndrome with need for fasciotomy)
- Outcome parameters (Survival, Rutherford ischemia classification, residual sensory or motor deficit, impaired walking distance, need for reintervention, major bleeding periprocedural, access site complications, organ failure) 30 and 90 days after diagnosis of ALI.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute lower limb ischemia | – | Procedure: Revascularization, Procedure: Primary major amputation, Other: Best medical treatmentPatients with acute lower limb ischemia (older than 18 years) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with the diagnosis of acute lower limb ischemia treated at a participating study center.
Key inclusion criteria (1 listed)
- Acute lower limb ischemia (Rutherford Categories I-III)
Key exclusion criteria (1 listed)
- No informed consent
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 |
|---|---|---|
| RevascularizationAlso: Surgical embolectomy, Peripheral bypass, Catheter directed thrombolysis, Catheter guided aspirationEndovascular or surgical restoration of arterial blood flow. | Procedure or surgery | Acute lower limb ischemia |
| Primary major amputationPrimary below- or above knee major amputation without prior revascularization. | Procedure or surgery | Acute lower limb ischemia |
| Best medical treatmentConservative treatment of acute lower limb ischemia - without prior revascularization. | Other | Acute lower limb ischemia |
Primary outcome
Amputation free survival - rate
Time frame: 90 days
Rate of amputation free survival after diagnosis of acute lower limb ischemia
5 secondary outcomes
Re-intervention rate of the index leg
Time frame: 90 days
Complication rate
Time frame: 90 days
Limb salvage rate
Time frame: 90 days
Survival rate
Time frame: 90 days
Clinical outcome of the index leg (Rutherford category)
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 31 Oct 2023.
- Background: PubMed 31128987Behrendt CA, Bjorck M, Schwaneberg T, Debus ES, Cronenwett J, Sigvant B; Acute Limb Ischaemia Collaborators. Editor's Choice - Recommendations for Registry Data Collection for Revascularisations of Acute Limb Ischaemia: A Delphi Consensus from the International Consortium of Vascular Registries. Eur J Vasc Endovasc Surg. 2019 Jun;57(6):816-821. doi: 10.1016/j.ejvs.2019.02.023. Epub 2019 May 22.
- Background: PubMed 31899099Bjorck M, Earnshaw JJ, Acosta S, Bastos Goncalves F, Cochennec F, Debus ES, Hinchliffe R, Jongkind V, Koelemay MJW, Menyhei G, Svetlikov AV, Tshomba Y, Van Den Berg JC, Esvs Guidelines Committee, de Borst GJ, Chakfe N, Kakkos SK, Koncar I, Lindholt JS, Tulamo R, Vega de Ceniga M, Vermassen F, Document Reviewers, Boyle JR, Mani K, Azuma N, Choke ETC, Cohnert TU, Fitridge RA, Forbes TL, Hamady MS, Munoz A, Muller-Hulsbeck S, Rai K. Editor's Choice - European Society for Vascular Surgery (ESVS) 2020 Clinical Practice Guidelines on the Management of Acute Limb Ischaemia. Eur J Vasc Endovasc Surg. 2020 Feb;59(2):173-218. doi: 10.1016/j.ejvs.2019.09.006. Epub 2019 Dec 31. No abstract available.
- Derived from this study: PubMed 40204031Doukas P, Enzmann FK, Noronen K, Tran L, Busch A, Zlatanovic P, Predenciuc A, Raffort J, Gratl A, Caradu C; EVRC Collaborative. Insights from the prospective multicentre observational study evaluating acute lower limb ischemia on the influence of patient characteristics on treatment strategy selection and outcomes. J Vasc Surg. 2025 Sep;82(3):987-997.e5. doi: 10.1016/j.jvs.2025.03.476. Epub 2025 Apr 7.
- Derived from this study: PubMed 36347128Gratl A; European Vascular Research Collaborative (EVRC). Study Protocol of a Prospective Multicenter Observational Study Evaluating Acute Lower Limb Ischemia. J Surg Res. 2023 Feb;282:280-284. doi: 10.1016/j.jss.2022.09.023. Epub 2022 Nov 5.
- 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.
Florian K Enzmann, MD, PhD principal investigator
Department of Vascular Surgery, Medical University of Innsbruck
Alexandra Gratl, MD principal investigator
Department of Vascular Surgery, Medical University of Innsbruck
37 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Limb Ischemia, run by Medical University Innsbruck at 37 sites in 10 countries.
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 1 inclusion and 1 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 31 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in France, Germany, Austria, Serbia, United Kingdom and 5 more countries. 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?
Amputation free survival - rate (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05138679, which also lists 4 linked publications.
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 31 Oct 2023.