Endovascular treatment of peripheral arterial disease: Endo-STAR framework for the design, conduct, and reporting of trials

Ewa M Zywicka^{1

2}, Andrew J Moore³, Christopher Twine^{1

2}, Christian-Alexander Behrendt⁴, Michel Bosiers⁵, Marianne Brodmann⁶, Edward Choke⁷, Gert J deBorst⁸, Athanasios Diamantopoulos⁹, Florian Enzmann¹⁰, Alik Farber¹¹, Gary Ansel¹², Dario Gattuso¹³, Gerard S Goh¹⁴, Goueffic Yann¹⁵, Shirley Jansen^{16

17}, Mario Landini¹⁸, Anne Lejay¹⁹, Michael Lichtenberg²⁰, Matthew Menard²¹, Peter Mezes²², Joseph Mills²³, Jane Nixon²⁴, Joakim Nordanstig²⁵, Kelly O'Connell²⁶, Baris Ozdemir², Lorenzo Patrone²⁷, Sapna Puppala²⁸, Athanasios Saratzis²⁹, Eric A Secemsky³⁰, Nikol Sigrid³¹, Konstantinos Stavroulakis³², Sabine Steiner³³, Martin Teraa³⁴, Isabelle Van Herzeele³⁵, Maarit Venermo³⁶, Thomas Zeller³⁷, Ronelle Mouton^{1

38}, Robert J Hinchliffe^{1

2}

Affiliations

¹ Translational Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.
² Department of Vascular Surgery, North Bristol NHS Trust, Bristol, UK.
³ Musculoskeletal Research Unit, Bristol Medical School, University of Bristol, Bristol, UK.
⁴ Department of Vascular and Endovascular Surgery, Asklepios Clinic Wandsbeck, Asklepios Medical School, Hamburg, Germany.
⁵ Department of Vascular Surgery, University Hospital Bern, University of Bern, Bern, Switzerland.
⁶ Division of Angiology, Medical University Graz, Graz, Austria.
⁷ Vascular and Endovascular Surgery Service, Department of General Surgery, Sengkang General Hospital, Singapore.
⁸ Department of Vascular Surgery G04.129, University Medical Centre Utrecht, Utrecht, The Netherlands.
⁹ Department of Interventional Radiology, Guy's and St Thomas' Hospitals, NHS Foundation Trust, London, UK.
¹⁰ Department of Vascular Surgery, Medical University of Innsbruck, Innsbruck, Austria.
¹¹ Division of Vascular and Endovascular Surgery, Boston Medical Center, Boston University Chobanian & Avedisian School of Medicine, Boston, Massachusetts, USA.
¹² Healthcare Insights, Columbus, Ohio, USA.
¹³ Concept Medical Inc., Tampa, Florida, USA.
¹⁴ Department of Radiology, Alfred Hospital, Melbourne, Victoria, Australia.
¹⁵ Service de chirurgie vasculaire et endovasculaire, Groupe Hospitalier Paris St Joseph, Paris, France.
¹⁶ Curtin Medical School, Curtin University, Perth, Western Australia, Australia.
¹⁷ Heart and Vascular Research Institute, Harry Perkins Institute of Medical Research, University of Western Australia, Perth, Western Australia, Australia.
¹⁸ Clinical and Business Development Europe, Middle East & Africa, Cordis, Miami Lakes, Florida, USA.
¹⁹ Department of Vascular Surgery, Kidney Transplantation and Innovation, Strasbourg University Hospital, Strasbourg, France.
²⁰ Vascular Centre, Klinikum Arnsberg, Arnsberg, Germany.
²¹ Division of Vascular and Endovascular Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.
²² Department of Interventional Radiology, North Bristol NHS Trust, Bristol, UK.
²³ Michael E. DeBakey Department of Surgery, Baylor College of Medicine, Houston, Texas, USA.
²⁴ Leeds Institute of Health Sciences, University of Leeds, Leeds, UK.
²⁵ Department of Vascular Surgery, Sahlgrenska University Hospital, Gothenburg, Sweden.
²⁶ Clinical Development Clinical & Medical Affairs, Philips Image Guided Therapy Corporation, Colorado Springs, Colorado, USA.
²⁷ Department of Interventional Radiology, West London Vascular and Interventional Centre, Northwick Park Hospital, Harrow, UK.
²⁸ Department of Interventional Vascular Radiology, Leeds Teaching Hospitals NHS Trust, Leeds General Infirmary, Leeds, UK.
²⁹ Department of Cardiovascular Sciences and NIHR Leicester Biomedical Research Centre, University of Leicester, Glenfield General Hospital, Leicester, UK.
³⁰ Division of Cardiology, Beth Israel Deaconess Medical Centre, Boston, Massachusetts, USA.
³¹ Department of Clinical and Interventional Angiology, Asklepios Klinik St Georg, Hamburg, Germany.
³² Department of Vascular Surgery, University Hospital, LMU Munich, Munich, Germany.
³³ Department of Angiology, University Hospital Leipzig, Leipzig, Germany.
³⁴ Department of Vascular Surgery, University Medical Centre Utrecht, Utrecht, The Netherlands.
³⁵ Department of Thoracic and Vascular Surgery, Ghent University Hospital, Ghent, Belgium.
³⁶ Department of Vascular Surgery, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.
³⁷ Abteilung Angiologie, Universitäts-Herzzentrum Freiburg-Bad Krozingen, Bad Krozingen, Germany.
³⁸ Department of Anaesthesia, North Bristol NHS Trust, Bristol, UK.

PMID: 40241414
PMCID: PMC12003854
DOI: 10.1093/bjs/znaf020

Endovascular treatment of peripheral arterial disease: Endo-STAR framework for the design, conduct, and reporting of trials

Ewa M Zywicka et al. Br J Surg. 2025.

. 2025 Mar 28;112(4):znaf020.

doi: 10.1093/bjs/znaf020.

Authors

Affiliations

¹ Translational Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.
² Department of Vascular Surgery, North Bristol NHS Trust, Bristol, UK.
³ Musculoskeletal Research Unit, Bristol Medical School, University of Bristol, Bristol, UK.
⁴ Department of Vascular and Endovascular Surgery, Asklepios Clinic Wandsbeck, Asklepios Medical School, Hamburg, Germany.
⁵ Department of Vascular Surgery, University Hospital Bern, University of Bern, Bern, Switzerland.
⁶ Division of Angiology, Medical University Graz, Graz, Austria.
⁷ Vascular and Endovascular Surgery Service, Department of General Surgery, Sengkang General Hospital, Singapore.
⁸ Department of Vascular Surgery G04.129, University Medical Centre Utrecht, Utrecht, The Netherlands.
⁹ Department of Interventional Radiology, Guy's and St Thomas' Hospitals, NHS Foundation Trust, London, UK.
¹⁰ Department of Vascular Surgery, Medical University of Innsbruck, Innsbruck, Austria.
¹¹ Division of Vascular and Endovascular Surgery, Boston Medical Center, Boston University Chobanian & Avedisian School of Medicine, Boston, Massachusetts, USA.
¹² Healthcare Insights, Columbus, Ohio, USA.
¹³ Concept Medical Inc., Tampa, Florida, USA.
¹⁴ Department of Radiology, Alfred Hospital, Melbourne, Victoria, Australia.
¹⁵ Service de chirurgie vasculaire et endovasculaire, Groupe Hospitalier Paris St Joseph, Paris, France.
¹⁶ Curtin Medical School, Curtin University, Perth, Western Australia, Australia.
¹⁷ Heart and Vascular Research Institute, Harry Perkins Institute of Medical Research, University of Western Australia, Perth, Western Australia, Australia.
¹⁸ Clinical and Business Development Europe, Middle East & Africa, Cordis, Miami Lakes, Florida, USA.
¹⁹ Department of Vascular Surgery, Kidney Transplantation and Innovation, Strasbourg University Hospital, Strasbourg, France.
²⁰ Vascular Centre, Klinikum Arnsberg, Arnsberg, Germany.
²¹ Division of Vascular and Endovascular Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.
²² Department of Interventional Radiology, North Bristol NHS Trust, Bristol, UK.
²³ Michael E. DeBakey Department of Surgery, Baylor College of Medicine, Houston, Texas, USA.
²⁴ Leeds Institute of Health Sciences, University of Leeds, Leeds, UK.
²⁵ Department of Vascular Surgery, Sahlgrenska University Hospital, Gothenburg, Sweden.
²⁶ Clinical Development Clinical & Medical Affairs, Philips Image Guided Therapy Corporation, Colorado Springs, Colorado, USA.
²⁷ Department of Interventional Radiology, West London Vascular and Interventional Centre, Northwick Park Hospital, Harrow, UK.
²⁸ Department of Interventional Vascular Radiology, Leeds Teaching Hospitals NHS Trust, Leeds General Infirmary, Leeds, UK.
²⁹ Department of Cardiovascular Sciences and NIHR Leicester Biomedical Research Centre, University of Leicester, Glenfield General Hospital, Leicester, UK.
³⁰ Division of Cardiology, Beth Israel Deaconess Medical Centre, Boston, Massachusetts, USA.
³¹ Department of Clinical and Interventional Angiology, Asklepios Klinik St Georg, Hamburg, Germany.
³² Department of Vascular Surgery, University Hospital, LMU Munich, Munich, Germany.
³³ Department of Angiology, University Hospital Leipzig, Leipzig, Germany.
³⁴ Department of Vascular Surgery, University Medical Centre Utrecht, Utrecht, The Netherlands.
³⁵ Department of Thoracic and Vascular Surgery, Ghent University Hospital, Ghent, Belgium.
³⁶ Department of Vascular Surgery, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.
³⁷ Abteilung Angiologie, Universitäts-Herzzentrum Freiburg-Bad Krozingen, Bad Krozingen, Germany.
³⁸ Department of Anaesthesia, North Bristol NHS Trust, Bristol, UK.

PMID: 40241414
PMCID: PMC12003854
DOI: 10.1093/bjs/znaf020

Erratum in

Correction to: Endovascular treatment of peripheral arterial disease: Endo-STAR framework for the design, conduct, and reporting of trials.
[No authors listed] [No authors listed] Br J Surg. 2025 Apr 30;112(5):znaf105. doi: 10.1093/bjs/znaf105. Br J Surg. 2025. PMID: 40332894 Free PMC article. No abstract available.

Abstract

Background: Endovascular technologies continue to evolve to meet the large and growing burden of peripheral arterial disease. The overall quality of published RCTs in endovascular treatments for peripheral arterial disease is low, resulting in uncertainty over treatment effectiveness. The aim of this study was to develop a framework to improve the design, conduct, and reporting of future clinical trials for infrainguinal endovascular treatments of peripheral arterial disease.

Methods: The authors undertook the design, development, and pilot testing of a novel framework. The study comprised four distinct phases. Phase 1 represented the development of a preliminary framework using content analysis of endovascular interventions described in previously published RCTs. Phase 2 consisted of focus groups with key stakeholders to further develop, revise, and achieve initial consensus on the framework. Phase 3 corresponded to the creation of a modified Delphi questionnaire to achieve final consensus on the framework. Phase 4 included cognitive interviews with professionals designing or undertaking endovascular lower limb trials to pilot test the framework.

Results: Content analysis of 228 endovascular interventions from 112 RCTs identified six key themes, relevant to endovascular peripheral arterial disease interventions, for the framework: expertise; setting; anaesthesia; imaging; intervention components (access; crossing lesion; treating lesion (lesion preparation; intervention; intervention optimization; bailout intervention; and treatment of non-target lesions); and closure of artery); and pharmacological interventions. Further refinements were made to the framework as a result of feedback from three focus groups and a Delphi questionnaire. The framework deconstructs an endovascular intervention into its component parts. The final framework can be accessed at www.endo-star.com. Pilot testing evaluated comprehension, clarity, and completeness of interpretation.

Conclusion: The Endo-STAR framework deconstructs endovascular interventions into their key component parts and has been designed and pilot tested to enhance the quality of RCTs of endovascular interventions in peripheral arterial disease. It may be used to assist in developing future trial protocols, the standardization of infrainguinal endovascular interventions, the monitoring of adherence to the trial protocol, and as a standardized reporting guideline.

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Figures

**Fig. 1**
Methodology PAD, peripheral arterial disease.

See this image and copyright information in PMC

References

1. GBD 2019 Peripheral Artery Disease Collaborators . Global burden of peripheral artery disease and its risk factors, 1990–2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet Glob Health 2023;11:e1553–e1565 - PMC - PubMed
1. Eid MA, Mehta K, Barnes JA, Wanken Z, Columbo JA, Stone DH et al. The global burden of peripheral artery disease. J Vasc Surg 2023;77:1119–1126.e1 - PubMed
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1. Goodney PP, Beck AW, Nagle J, Welch HG, Zwolak RM. National trends in lower extremity bypass surgery, endovascular interventions, and major amputations. J Vasc Surg 2009;50:54–60 - PubMed

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Endovascular treatment of peripheral arterial disease: Endo-STAR framework for the design, conduct, and reporting of trials

Affiliations

Endovascular treatment of peripheral arterial disease: Endo-STAR framework for the design, conduct, and reporting of trials

Authors

Affiliations

Erratum in

Abstract

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References

MeSH terms

Grants and funding

LinkOut - more resources

Full Text Sources

Medical