Study Protocol of a Prospective Multicenter Observational Study Evaluating Acute Lower Limb Ischemia

Alexandra Gratl; European Vascular Research Collaborative (EVRC)

doi:10.1016/j.jss.2022.09.023

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.

Authors

Alexandra Gratl¹; European Vascular Research Collaborative (EVRC)

Collaborators

European Vascular Research Collaborative (EVRC):
Gert de Borst², Albert Busch³, Panagiotids Doukas⁴, Florian Enzmann⁵, Alexander Gombert⁴, Alexandra Gratl⁵, Robert Hinchliffe⁶, Bergrós Jóhannesdóttir⁷, Vincent Jongkind⁸, Fabien Lareyre⁹, Lewis Meecham¹⁰, Martin Teraa², Salome Weiss¹¹, Petar Zlatanovic¹²

Affiliations

¹ Department of Vascular Surgery, Medical University of Innsbruck, Innsbruck, Austria. Electronic address: Alexandra.gratl@i-med.ac.at.
² Department of Vascular Surgery, University Medical Center Utrecht, the Netherlands.
³ Division of Vascular and Endovascular Surgery, Department for Visceral, Thoracic and Vascular Surgery, University Hospital Carl Gustav Carus, University of Dresden, Germany.
⁴ European Vascular Centre Aachen-Maastricht, Department of Vascular Surgery, University Hospital RWTH Aachen, Germany.
⁵ Department of Vascular Surgery, Medical University of Innsbruck, Innsbruck, Austria.
⁶ Bristol Centre for Surgical Research, Bristol NIHR Biomedical research Centre, University of Bristol, United Kingdom.
⁷ Department of Vascular Surgery, University Hospital of Haukeland, Bergen, Norway.
⁸ Department of Vascular Surgery, Amsterdam UMC, Amsterdam Cardiovascular Science, Amsterdam, the Netherlands.
⁹ Department of Vascular Surgery, Hospital of Antibes Juan-les-Pins, Antibes, France.
¹⁰ Department of Vascular Surgery, University Hospital Wales, Cardiff, United Kingdom.
¹¹ Department of Cardiovascular Surgery, Inselspital, Bern University Hospital, University of Bern, Switzerland.
¹² Clinical for Vascular and Endovascular Surgery, Clinical Centre of Serbia, Belgrade, Serbia.

PMID: 36347128
DOI: 10.1016/j.jss.2022.09.023

Abstract

Introduction: Acute lower limb ischemia (ALI) is a limb- and potentially life-threatening condition which requires urgent evaluation and treatment. Contemporary data on optimal therapy and prognosis of ALI are lacking, while surgical, hybrid, and foremost endovascular techniques have rapidly evolved over the past decades. Available clinical guidelines are not based on high-level evidence and do not fully reflect day-do-day practice. Contemporary data on etiology, procedural strategies as well as patient outcomes in ALI are urgently needed to improve care and prevent limb loss. The current study was initiated by the European Vascular Research Collaborative (EVRC), established by young European vascular specialists, and aims to provide insight into contemporary treatment strategies in ALI and its clinical results within Europe. In this manuscript we report the rationale and a detailed study protocol.

Material and methods: The proposed study is a prospective, international, multicenter, observational study on ALI (PROMOTE-ALI) (ClinicalTrials.gov - NCT05138679). Patients with ALI (Rutherford classification grade I -III) of one or both lower extremities will be included in the study. The primary endpoint of the study is amputation-free survival (AFS) at 30 d. Secondary endpoints are freedom from target limb reintervention, freedom from complications, clinical outcome of the index leg, and limb salvage and survival at 30 and 90 d after diagnosis of ALI.

Conclusions: ALI remains a challenging condition and due to the heterogeneous etiology, clinical presentation and treatment strategies, a large multicenter study on this topic is needed to gain contemporary data on clinical outcomes and prognosis, especially for modern endovascular techniques. PROMOTE-ALI is expected to provide these data and set a benchmark for future randomized controlled trials (RCTs).

Keywords: Acute limb ischemia; Amputation rate; Limb salvage; Observational; Study protocol.

MeSH terms

Acute Disease
Humans
Ischemia* / diagnosis
Ischemia* / etiology
Ischemia* / surgery
Multicenter Studies as Topic
Observational Studies as Topic
Peripheral Vascular Diseases*
Prospective Studies
Treatment Outcome

Associated data

ClinicalTrials.gov/NCT05138679