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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.
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guidelines highlighted that the available evidence on the management of acute lower limb ischemia (ALI) is mostly outdated and includes only small patient cohorts.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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acute lower limb ischemia | Patients with acute lower limb ischemia (older than 18 years) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Revascularization | Procedure | Endovascular or surgical restoration of arterial blood flow. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Amputation free survival - rate | Rate of amputation free survival after diagnosis of acute lower limb ischemia | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Re-intervention rate of the index leg | Rate of re-intervention for revascularization or complications of the index-leg | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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All patients with the diagnosis of acute lower limb ischemia treated at a participating study center.
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| Name | Affiliation | Role |
|---|---|---|
| Florian K Enzmann, MD, PhD | Department of Vascular Surgery, Medical University of Innsbruck | Principal Investigator |
| Alexandra Gratl, MD | Department of Vascular Surgery, Medical University of Innsbruck | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Innsbruck, Department of Vascular Surgery | Innsbruck | 6020 | Austria | |||
| Department of General Surgery, Division of Vascular Surgery, Medical University of Vienna |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31128987 | Background | 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. | |
| 31899099 |
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| Primary major amputation | Procedure | Primary below- or above knee major amputation without prior revascularization. |
|
| Best medical treatment | Other | Conservative treatment of acute lower limb ischemia - without prior revascularization. |
|
| 90 days |
| Limb salvage rate | Rate of patients not requiring major amputation. | 90 days |
| Survival rate | Rate of patients surviving the diagnosis of acute limb ischemia until the end of follow-up | 90 days |
| Clinical outcome of the index leg (Rutherford category) | Clinical symptoms at the end of follow up (Rutherford category) | 90 days |
| Vienna |
| 1090 |
| Austria |
| Department of Vascular and Endovascular Surgery, Hospital Ottakring | Vienna | 1160 | Austria |
| Department of Cardio-Vascular Surgery, Clinic Floridsdorf and Karl Landsteiner Institute for Cardio-Vascular Research | Vienna | 1210 | Austria |
| University Hospital Merkur | Zagreb | 10000 | Croatia |
| Department of Vascular Surgery, Hospital of Antibes Juan-les-Pins | Antibes | France |
| Department of Vascular Surgery, Bordeaux University Hospital | Bordeaux | France |
| Department of Vascular Surgery, Ambroise Paré University Hospital, Assistance Publique-Hôpitaux de Paris | Boulogne-Billancourt | 92100 | France |
| Department of Vascular and Endovascular Surgery, Brest University Hospital | Brest | France |
| Department of Vascular Surgery, Henri Mondor University Hospital | Créteil | France |
| Department of Vascular Surgery, University Hospital of Dijon | Dijon | France |
| Vascular Surgery Department, Hospices Civils de Lyon | Lyon | France |
| Department of Vascular Surgery, University Hospital of Nancy | Nancy | France |
| CHU Nantes, l'institut du thorax, service de chirurgie cardio-vasculaire | Nantes | France |
| University Hospital of Nice, Université Côte d'Azur | Nice | France |
| Department of Vascular and Thoracic Surgery, Bichat Hospital, Paris, Université de Paris | Paris | France |
| 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 | France |
| Vascular Surgery Department, Georges Pompidou European Hospital, APHP, Paris University | Paris | France |
| Department of Vascular Surgery, CHU de Reims | Reims | France |
| Department of Vascular Surgery and Kidney Transplantation, University Hospitals of Strasbourg | Strasbourg | France |
| European Vascular Center Aachen-Maastricht, University Hospital Aachen, RWTH Aachen University | Aachen | Germany |
| University Hospital Cologne | Cologne | Germany |
| 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 | Germany |
| Department of Vascular- and Endovascular Surgery, Medical Faculty and University Hospital Düsseldorf, Heinrich-Heine-University Düsseldorf | Düsseldorf | Germany |
| Department of Vascular and Endovascular Surgery, University Hospital Münster | Münster | Germany |
| Department of Vascular and Endovascular Surgery, Heart and Vascular Center, Semmelweis University | Budapest | Hungary |
| University Hopspital Chișinău | Chisinau | Moldova |
| Amsterdam University Medical Center, Department of Surgery | Amsterdam | 1105 AZ | Netherlands |
| University Medical Center Utrecht, Department of Vascular Surgery | Utrecht | 3584 CX | Netherlands |
| Clinic for Vascular and Endovascular Surgery, Clinical Center of Serbia | Belgrade | Serbia |
| Institute for Cardiovascular Disease, Belgrade | Belgrade | Serbia |
| Clinic for Vascular Surgery, Clinical Center Niš | Niš | Serbia |
| Department of Cardiovascular Surgery, Inselspital, University of Bern | Bern | 3010 | Switzerland |
| Department of Vascular Surgery, Kantonsspital Winterthur | Winterthur | Switzerland |
| Bristol Centre for Surgical Research, Bristol NIHR Biomedical Research Centre, University of Bristol | Bristol | United Kingdom |
| Department of Vascular Surgery, University Hospital Wales | Cardiff | United Kingdom |
| NHS Lothian | Edinburgh | EH1 3EG | United Kingdom |
| Background |
| Bjorck 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. |
| 40204031 | Derived | Doukas 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. |
| 36347128 | Derived | Gratl 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. |
| ID | Term |
|---|---|
| D003161 | Compartment Syndromes |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D017130 | Angioplasty |
| ID | Term |
|---|---|
| D002404 | Catheterization |
| D013812 | Therapeutics |
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
| D008919 | Investigative Techniques |
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