Study Results
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Basic Information
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COMPLETED
700 participants
OBSERVATIONAL
2021-12-01
2023-08-31
Brief Summary
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OUTCOME OF PATIENTS ADMITTED WITH ACUTE LOWER EXTREMITY ISCHEMIA
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Acute lower limb ischemia
Patients with acute lower limb ischemia (older than 18 years)
Revascularization
Endovascular or surgical restoration of arterial blood flow.
Primary major amputation
Primary below- or above knee major amputation without prior revascularization.
Best medical treatment
Conservative treatment of acute lower limb ischemia - without prior revascularization.
Interventions
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Revascularization
Endovascular or surgical restoration of arterial blood flow.
Primary major amputation
Primary below- or above knee major amputation without prior revascularization.
Best medical treatment
Conservative treatment of acute lower limb ischemia - without prior revascularization.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Medical University Innsbruck
OTHER
Responsible Party
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Principal Investigators
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Florian K Enzmann, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Vascular Surgery, Medical University of Innsbruck
Alexandra Gratl, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Vascular Surgery, Medical University of Innsbruck
Locations
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Medical University of Innsbruck, Department of Vascular Surgery
Innsbruck, , Austria
Department of General Surgery, Division of Vascular Surgery, Medical University of Vienna
Vienna, , Austria
Department of Vascular and Endovascular Surgery, Hospital Ottakring
Vienna, , Austria
Department of Cardio-Vascular Surgery, Clinic Floridsdorf and Karl Landsteiner Institute for Cardio-Vascular Research
Vienna, , Austria
University Hospital Merkur
Zagreb, , 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, , 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, , Netherlands
University Medical Center Utrecht, Department of Vascular Surgery
Utrecht, , 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, , 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, , United Kingdom
Countries
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References
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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.
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.
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.
Other Identifiers
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1220/2021
Identifier Type: -
Identifier Source: org_study_id
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