Evaluation of Acute Lower Limb Ischemia

Acute Limb Ischemia Clinical Trial

— PROMOTE-ALI  

Official title:

Prospective Multicenter Observational Study Evaluating Acute Lower Limb Ischemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05138679
• Other study ID #: 1220/2021
• Status: Completed
• Start date: December 1, 2021
• Est. completion date: August 31, 2023

Study information

• Verified date: August 2021
• Source: Medical University Innsbruck
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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guidelines highlighted that the available evidence on the management of acute lower limb ischemia (ALI) is mostly outdated and includes only small patient cohorts.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

• Status: Completed
• Enrollment: 700
• Est. completion date: August 31, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• No informed consent

Related Conditions & MeSH terms

• Acute Limb Ischemia
• Ischemia

Intervention

Procedure:
• Revascularization
Endovascular or surgical restoration of arterial blood flow.
• Primary major amputation
Primary below- or above knee major amputation without prior revascularization.

Other:
• Best medical treatment
Conservative treatment of acute lower limb ischemia - without prior revascularization.

Locations

Country	Name	City	State
Austria	Medical University of Innsbruck, Department of Vascular Surgery	Innsbruck
Austria	Department of Cardio-Vascular Surgery, Clinic Floridsdorf and Karl Landsteiner Institute for Cardio-Vascular Research	Vienna
Austria	Department of General Surgery, Division of Vascular Surgery, Medical University of Vienna	Vienna
Austria	Department of Vascular and Endovascular Surgery, Hospital Ottakring	Vienna
Croatia	University Hospital Merkur	Zagreb
France	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
Germany	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
Hungary	Department of Vascular and Endovascular Surgery, Heart and Vascular Center, Semmelweis University	Budapest
Moldova, Republic of	University Hopspital Chi?inau	Chisinau
Netherlands	Amsterdam University Medical Center, Department of Surgery	Amsterdam
Netherlands	University Medical Center Utrecht, Department of Vascular Surgery	Utrecht
Serbia	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
Switzerland	Department of Cardiovascular Surgery, Inselspital, University of Bern	Bern
Switzerland	Department of Vascular Surgery, Kantonsspital Winterthur	Winterthur
United Kingdom	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

Sponsors (1)

Lead Sponsor	Collaborator
Medical University Innsbruck

Countries where clinical trial is conducted

Austria,  Croatia,  France,  Germany,  Hungary,  Moldova, Republic of,  Netherlands,  Serbia,  Switzerland,  United Kingdom, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amputation free survival - rate	Rate of amputation free survival after diagnosis of acute lower limb ischemia	90 days
Secondary	Re-intervention rate of the index leg	Rate of re-intervention for revascularization or complications of the index-leg	90 days
Secondary	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)	90 days
Secondary	Limb salvage rate	Rate of patients not requiring major amputation.	90 days
Secondary	Survival rate	Rate of patients surviving the diagnosis of acute limb ischemia until the end of follow-up	90 days
Secondary	Clinical outcome of the index leg (Rutherford category)	Clinical symptoms at the end of follow up (Rutherford category)	90 days