Evaluation of Acute Lower Limb Ischemia

NCT05138679 | Completed DMC

• 1 other identifier: 1220/2021
• Study Type: observational
• Target: 700
• Locations: 10 countries
• Sites: 37

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.

Conditions

Acute Limb Ischemia

Keywords

acute lower limb ischemia; revascularization; compartment syndrome; limb salvage; COVID-19

Outcome Measures

Primary Outcomes (1)

• Amputation free survival - rate

  Rate of amputation free survival after diagnosis of acute lower limb ischemia

  90 days

Secondary Outcomes (5)

• Re-intervention rate of the index leg

  90 days

• Complication rate

  90 days

• Limb salvage rate

  90 days

• Survival rate

  90 days

• Clinical outcome of the index leg (Rutherford category)

  90 days

Study Arms (1)

Acute lower limb ischemia

Patients with acute lower limb ischemia (older than 18 years)

Procedure: Revascularization; Procedure: Primary major amputation; Other: Best medical treatment

Interventions

Revascularization PROCEDURE

Endovascular or surgical restoration of arterial blood flow.

Also known as: Surgical embolectomy, Peripheral bypass, Catheter directed thrombolysis, Catheter guided aspiration, Catheter guided atherectomy, Percutaneous transluminal angioplasty

Acute lower limb ischemia

Primary major amputation PROCEDURE

Primary below- or above knee major amputation without prior revascularization.

Acute lower limb ischemia

Best medical treatment OTHER

Conservative treatment of acute lower limb ischemia - without prior revascularization.

Acute lower limb ischemia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients with the diagnosis of acute lower limb ischemia treated at a participating study center.

You may qualify if:

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

You may not qualify if:

• No informed consent

Sponsors & Collaborators

• Medical University Innsbruck: lead

Study Sites (37)

Medical University of Innsbruck, Department of Vascular Surgery

Innsbruck, 6020, Austria

Location

Department of General Surgery, Division of Vascular Surgery, Medical University of Vienna

Vienna, 1090, Austria

Location

Department of Vascular and Endovascular Surgery, Hospital Ottakring

Vienna, 1160, Austria

Location

Department of Cardio-Vascular Surgery, Clinic Floridsdorf and Karl Landsteiner Institute for Cardio-Vascular Research

Vienna, 1210, Austria

Location

University Hospital Merkur

Zagreb, 10000, Croatia

Location

Department of Vascular Surgery, Hospital of Antibes Juan-les-Pins

Antibes, France

Location

Department of Vascular Surgery, Bordeaux University Hospital

Bordeaux, France

Location

Department of Vascular Surgery, Ambroise Paré University Hospital, Assistance Publique-Hôpitaux de Paris

Boulogne-Billancourt, 92100, France

Location

Department of Vascular and Endovascular Surgery, Brest University Hospital

Brest, France

Location

Department of Vascular Surgery, Henri Mondor University Hospital

Créteil, France

Location

Department of Vascular Surgery, University Hospital of Dijon

Dijon, France

Location

Vascular Surgery Department, Hospices Civils de Lyon

Lyon, France

Location

Department of Vascular Surgery, University Hospital of Nancy

Nancy, France

Location

CHU Nantes, l'institut du thorax, service de chirurgie cardio-vasculaire

Nantes, France

Location

University Hospital of Nice, Université Côte d'Azur

Nice, France

Location

Department of Vascular and Thoracic Surgery, Bichat Hospital, Paris, Université de Paris

Paris, France

Location

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

Location

Vascular Surgery Department, Georges Pompidou European Hospital, APHP, Paris University

Paris, France

Location

Department of Vascular Surgery, CHU de Reims

Reims, France

Location

Department of Vascular Surgery and Kidney Transplantation, University Hospitals of Strasbourg

Strasbourg, France

Location

European Vascular Center Aachen-Maastricht, University Hospital Aachen, RWTH Aachen University

Aachen, Germany

Location

University Hospital Cologne

Cologne, Germany

Location

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

Location

Department of Vascular- and Endovascular Surgery, Medical Faculty and University Hospital Düsseldorf, Heinrich-Heine-University Düsseldorf

Düsseldorf, Germany

Location

Department of Vascular and Endovascular Surgery, University Hospital Münster

Münster, Germany

Location

Department of Vascular and Endovascular Surgery, Heart and Vascular Center, Semmelweis University

Budapest, Hungary

Location

University Hopspital Chișinău

Chisinau, Moldova

Location

Amsterdam University Medical Center, Department of Surgery

Amsterdam, 1105 AZ, Netherlands

Location

University Medical Center Utrecht, Department of Vascular Surgery

Utrecht, 3584 CX, Netherlands

Location

Clinic for Vascular and Endovascular Surgery, Clinical Center of Serbia

Belgrade, Serbia

Location

Institute for Cardiovascular Disease, Belgrade

Belgrade, Serbia

Location

Clinic for Vascular Surgery, Clinical Center Niš

Niš, Serbia

Location

Department of Cardiovascular Surgery, Inselspital, University of Bern

Bern, 3010, Switzerland

Location

Department of Vascular Surgery, Kantonsspital Winterthur

Winterthur, Switzerland

Location

Bristol Centre for Surgical Research, Bristol NIHR Biomedical Research Centre, University of Bristol

Bristol, United Kingdom

Location

Department of Vascular Surgery, University Hospital Wales

Cardiff, United Kingdom

Location

NHS Lothian

Edinburgh, EH1 3EG, United Kingdom

Location

Related Publications (3)

• 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.

  PMID: 31128987 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.

  PMID: 31899099 BACKGROUND

• 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.

  PMID: 36347128 DERIVED

MeSH Terms

Conditions

Compartment Syndromes; COVID-19

Interventions

Angioplasty

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Vascular Diseases; Cardiovascular Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Officials

• 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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2021
• First Posted: December 1, 2021
• Study Start: December 1, 2021
• Primary Completion: May 31, 2023
• Study Completion: August 31, 2023
• Last Updated: October 31, 2023

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

NL (2); HU (1); SE (3); CR (1); DE (5); AU (4); MO (1); FR (15); CH (2); GB (3)