Evaluation of Acute Lower Limb Ischemia
- Conditions
- Acute Limb Ischemia
- Interventions
- Procedure: RevascularizationProcedure: Primary major amputationOther: Best medical treatment
- Registration Number
- NCT05138679
- Lead Sponsor
- Medical University Innsbruck
- Brief 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 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guidelines highlighted that the available evidence on the management of acute lower limb ischemia (ALI) is mostly outdated and includes only small patient cohorts.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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 700
- Acute lower limb ischemia (Rutherford Categories I-III)
- No informed consent
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Acute lower limb ischemia Primary major amputation Patients with acute lower limb ischemia (older than 18 years) Acute lower limb ischemia Revascularization Patients with acute lower limb ischemia (older than 18 years) Acute lower limb ischemia Best medical treatment Patients with acute lower limb ischemia (older than 18 years)
- Primary Outcome Measures
Name Time Method Amputation free survival - rate 90 days Rate of amputation free survival after diagnosis of acute lower limb ischemia
- Secondary Outcome Measures
Name Time Method Limb salvage rate 90 days Rate of patients not requiring major amputation.
Survival rate 90 days Rate of patients surviving the diagnosis of acute limb ischemia until the end of follow-up
Re-intervention rate of the index leg 90 days Rate of re-intervention for revascularization or complications of the index-leg
Clinical outcome of the index leg (Rutherford category) 90 days Clinical symptoms at the end of follow up (Rutherford category)
Complication rate 90 days Rate of complications after the diagnosis of acute limb ischemia (access site infection, acute kidney injury, periprocedural major bleeding, compartment syndrome, multi organ failure)
Trial Locations
- Locations (37)
Amsterdam University Medical Center, Department of Surgery
🇳🇱Amsterdam, Netherlands
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 Surgery, Hospital of Antibes Juan-les-Pins
🇫🇷Antibes, France
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
ðŸ‡ðŸ‡·Zagreb, Croatia
Department of Vascular Surgery, Bordeaux University Hospital
🇫🇷Bordeaux, 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, Ambroise Paré University Hospital, Assistance Publique-Hôpitaux de Paris
🇫🇷Boulogne-Billancourt, 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
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 and Thoracic Surgery, Bichat Hospital, Paris, Université de Paris
🇫🇷Paris, France
University Hospital of Nice, Université Côte d'Azur
🇫🇷Nice, France
CHU Nantes, l'institut du thorax, service de chirurgie cardio-vasculaire
🇫🇷Nantes, France
Department of Vascular Surgery, CHU de Reims
🇫🇷Reims, France
European Vascular Center Aachen-Maastricht, University Hospital Aachen, RWTH Aachen University
🇩🇪Aachen, Germany
Department of Vascular Surgery and Kidney Transplantation, University Hospitals of Strasbourg
🇫🇷Strasbourg, France
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, University Hospital Münster
🇩🇪Münster, Germany
Department of Vascular- and Endovascular Surgery, Medical Faculty and University Hospital Düsseldorf, Heinrich-Heine-University Düsseldorf
🇩🇪Düsseldorf, Germany
University Hopspital Chișinău
🇲🇩Chisinau, Moldova, Republic of
Department of Vascular and Endovascular Surgery, Heart and Vascular Center, Semmelweis University
ðŸ‡ðŸ‡ºBudapest, Hungary
University Medical Center Utrecht, Department of Vascular Surgery
🇳🇱Utrecht, Netherlands
Institute for Cardiovascular Disease, Belgrade
🇷🇸Belgrade, Serbia
Clinic for Vascular and Endovascular Surgery, Clinical Center of Serbia
🇷🇸Belgrade, Serbia
Department of Cardiovascular Surgery, Inselspital, University of Bern
🇨ðŸ‡Bern, Switzerland
Clinic for Vascular Surgery, Clinical Center Niš
🇷🇸Niš, Serbia
Department of Vascular Surgery, Kantonsspital Winterthur
🇨ðŸ‡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