Clinical trial NCT05138679: Evaluation of Acute Lower Limb Ischemia
Official title: Prospective Multicenter Observational Study Evaluating Acute Lower Limb Ischemia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Limb Ischemia
Keywords: acute lower limb ischemia
revascularization
compartment syndrome
limb salvage
COVID-19
Lead sponsor: Medical University Innsbruck
Sponsor class: OTHER
First posted: 2021-12-01
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with the diagnosis of acute lower limb ischemia treated at a participating study center.

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guidelines highlighted that the available evidence on the management of acute lower limb ischemia (ALI) is mostly outdated and includes only small patient cohorts.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.

Eligibility criteria: Inclusion Criteria:

* Acute lower limb ischemia (Rutherford Categories I-III)

Exclusion Criteria:

* No informed consent

Primary outcomes:
measure: Amputation free survival - rate
timeFrame: 90 days
Secondary outcomes:
measure: Re-intervention rate of the index leg
timeFrame: 90 days
measure: Complication rate
timeFrame: 90 days
measure: Limb salvage rate
timeFrame: 90 days
measure: Survival rate
timeFrame: 90 days
measure: Clinical outcome of the index leg (Rutherford category)
timeFrame: 90 days
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Medical University of Innsbruck, Department of Vascular Surgery
city: Vienna
country: Austria
facility: Department of General Surgery, Division of Vascular Surgery, Medical University of Vienna
city: Vienna
country: Austria
facility: Department of Vascular and Endovascular Surgery, Hospital Ottakring
city: Vienna
country: Austria
facility: Department of Cardio-Vascular Surgery, Clinic Floridsdorf and Karl Landsteiner Institute for Cardio-Vascular Research
city: Zagreb
country: Croatia
facility: University Hospital Merkur
city: Antibes
country: France
facility: Department of Vascular Surgery, Hospital of Antibes Juan-les-Pins
city: Bordeaux
country: France
facility: Department of Vascular Surgery, Bordeaux University Hospital
city: Boulogne-Billancourt
country: France
facility: Department of Vascular Surgery, Ambroise Paré University Hospital, Assistance Publique-Hôpitaux de Paris
city: Brest
country: France
facility: Department of Vascular and Endovascular Surgery, Brest University Hospital
city: Créteil
country: France
facility: Department of Vascular Surgery, Henri Mondor University Hospital
city: Dijon
country: France
facility: Department of Vascular Surgery, University Hospital of Dijon
city: Lyon
country: France
facility: Vascular Surgery Department, Hospices Civils de Lyon
city: Nancy
country: France
facility: Department of Vascular Surgery, University Hospital of Nancy
city: Nantes
country: France
facility: CHU Nantes, l'institut du thorax, service de chirurgie cardio-vasculaire
city: Nice
country: France
facility: University Hospital of Nice, Université Côte d'Azur
city: Paris
country: France
facility: Department of Vascular and Thoracic Surgery, Bichat Hospital, Paris, Université de Paris
city: Paris
country: France
facility: 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
city: Paris
country: France
facility: Vascular Surgery Department, Georges Pompidou European Hospital, APHP, Paris University
city: Reims
country: France
facility: Department of Vascular Surgery, CHU de Reims
city: Strasbourg
country: France
facility: Department of Vascular Surgery and Kidney Transplantation, University Hospitals of Strasbourg
city: Aachen
country: Germany
facility: European Vascular Center Aachen-Maastricht, University Hospital Aachen, RWTH Aachen University
city: Cologne
country: Germany
facility: University Hospital Cologne
city: Dresden
country: Germany
facility: 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
city: Düsseldorf
country: Germany
facility: Department of Vascular- and Endovascular Surgery, Medical Faculty and University Hospital Düsseldorf, Heinrich-Heine-University Düsseldorf
city: Münster
country: Germany
facility: Department of Vascular and Endovascular Surgery, University Hospital Münster
city: Budapest
country: Hungary
facility: Department of Vascular and Endovascular Surgery, Heart and Vascular Center, Semmelweis University
city: Chisinau
country: Moldova, Republic of
facility: University Hopspital Chișinău
city: Amsterdam
country: Netherlands
facility: Amsterdam University Medical Center, Department of Surgery
city: Utrecht
country: Netherlands
facility: University Medical Center Utrecht, Department of Vascular Surgery
city: Belgrade
country: Serbia
facility: Clinic for Vascular and Endovascular Surgery, Clinical Center of Serbia
city: Belgrade
country: Serbia
facility: Institute for Cardiovascular Disease, Belgrade
city: Niš
country: Serbia
facility: Clinic for Vascular Surgery, Clinical Center Niš
city: Bern
country: Switzerland
facility: Department of Cardiovascular Surgery, Inselspital, University of Bern
city: Winterthur
country: Switzerland
facility: Department of Vascular Surgery, Kantonsspital Winterthur
city: Bristol
country: United Kingdom
facility: Bristol Centre for Surgical Research, Bristol NIHR Biomedical Research Centre, University of Bristol
city: Cardiff
country: United Kingdom
facility: Department of Vascular Surgery, University Hospital Wales
city: Edinburgh
country: United Kingdom
facility: NHS Lothian
Study officials:
affiliation: Department of Vascular Surgery, Medical University of Innsbruck
name: Florian K Enzmann, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Vascular Surgery, Medical University of Innsbruck
name: Alexandra Gratl, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.