Evidence map›Paper›PMID 40241414›Full record

ArticleThe British journal of surgery2025

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

Ewa M Zywicka, Andrew J Moore, Christopher Twine, Christian-Alexander Behrendt, Michel Bosiers, Marianne Brodmann, Edward Choke, Gert J deBorst, Athanasios Diamantopoulos, Florian Enzmann and 29 more

Erratum issuedAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in The British journal of surgery, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Trial
  2. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

39 authors.

Ewa M ZywickaTranslational Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.
Andrew J MooreMusculoskeletal Research Unit, Bristol Medical School, University of Bristol, Bristol, UK.ORCID 0000-0003-3185-1599
Christopher TwineTranslational Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.
Christian-Alexander BehrendtDepartment of Vascular and Endovascular Surgery, Asklepios Clinic Wandsbeck, Asklepios Medical School, Hamburg, Germany.
Michel BosiersDepartment of Vascular Surgery, University Hospital Bern, University of Bern, Bern, Switzerland.
Marianne BrodmannDivision of Angiology, Medical University Graz, Graz, Austria.
Edward ChokeVascular and Endovascular Surgery Service, Department of General Surgery, Sengkang General Hospital, Singapore.
Gert J deBorstDepartment of Vascular Surgery G04.129, University Medical Centre Utrecht, Utrecht, The Netherlands.
Athanasios DiamantopoulosDepartment of Interventional Radiology, Guy's and St Thomas' Hospitals, NHS Foundation Trust, London, UK.
Florian EnzmannDepartment of Vascular Surgery, Medical University of Innsbruck, Innsbruck, Austria.ORCID 0000-0002-7200-4145
Alik FarberDivision of Vascular and Endovascular Surgery, Boston Medical Center, Boston University Chobanian & Avedisian School of Medicine, Boston, Massachusetts, USA.
Gary AnselHealthcare Insights, Columbus, Ohio, USA.
Dario GattusoConcept Medical Inc., Tampa, Florida, USA.ORCID 0009-0002-6740-2779
Gerard S GohDepartment of Radiology, Alfred Hospital, Melbourne, Victoria, Australia.ORCID 0000-0002-1552-5470
Goueffic YannService de chirurgie vasculaire et endovasculaire, Groupe Hospitalier Paris St Joseph, Paris, France.
Shirley JansenCurtin Medical School, Curtin University, Perth, Western Australia, Australia.
Mario LandiniClinical and Business Development Europe, Middle East & Africa, Cordis, Miami Lakes, Florida, USA.
Anne LejayDepartment of Vascular Surgery, Kidney Transplantation and Innovation, Strasbourg University Hospital, Strasbourg, France.
Michael LichtenbergVascular Centre, Klinikum Arnsberg, Arnsberg, Germany.
Matthew MenardDivision of Vascular and Endovascular Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.ORCID 0000-0003-2470-7978
Peter MezesDepartment of Interventional Radiology, North Bristol NHS Trust, Bristol, UK.
Joseph MillsMichael E. DeBakey Department of Surgery, Baylor College of Medicine, Houston, Texas, USA.
Jane NixonLeeds Institute of Health Sciences, University of Leeds, Leeds, UK.
Joakim NordanstigDepartment of Vascular Surgery, Sahlgrenska University Hospital, Gothenburg, Sweden.ORCID 0000-0002-2670-2268
Kelly O'ConnellClinical Development Clinical & Medical Affairs, Philips Image Guided Therapy Corporation, Colorado Springs, Colorado, USA.
Baris OzdemirDepartment of Vascular Surgery, North Bristol NHS Trust, Bristol, UK.
Lorenzo PatroneDepartment of Interventional Radiology, West London Vascular and Interventional Centre, Northwick Park Hospital, Harrow, UK.
Sapna PuppalaDepartment of Interventional Vascular Radiology, Leeds Teaching Hospitals NHS Trust, Leeds General Infirmary, Leeds, UK.
Athanasios SaratzisDepartment of Cardiovascular Sciences and NIHR Leicester Biomedical Research Centre, University of Leicester, Glenfield General Hospital, Leicester, UK.
Eric A SecemskyDivision of Cardiology, Beth Israel Deaconess Medical Centre, Boston, Massachusetts, USA.ORCID 0000-0003-3861-3163
Nikol SigridDepartment of Clinical and Interventional Angiology, Asklepios Klinik St Georg, Hamburg, Germany.
Konstantinos StavroulakisDepartment of Vascular Surgery, University Hospital, LMU Munich, Munich, Germany.ORCID 0000-0002-9775-9210
Sabine SteinerDepartment of Angiology, University Hospital Leipzig, Leipzig, Germany.
Martin TeraaDepartment of Vascular Surgery, University Medical Centre Utrecht, Utrecht, The Netherlands.
Isabelle Van HerzeeleDepartment of Thoracic and Vascular Surgery, Ghent University Hospital, Ghent, Belgium.ORCID 0000-0002-1754-7390
Maarit VenermoDepartment of Vascular Surgery, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.ORCID 0000-0001-8814-0988
Thomas ZellerAbteilung Angiologie, Universitäts-Herzzentrum Freiburg-Bad Krozingen, Bad Krozingen, Germany.
Ronelle MoutonTranslational Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.ORCID 0000-0001-9562-8199
Robert J HinchliffeTranslational Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.ORCID 0000-0002-6370-0800

Funding

Department of Research & Innovation at North Bristol NHS TrustLinder FoundationNIHR Biomedical Research Centre at University Hospitals Bristol NHS Foundation TrustUniversity of Bristol
6 · The paper itself

Abstract

backgroundEndovascular 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.

methodsThe 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.

resultsContent 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.

conclusionThe 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.

Indexed as

Endovascular ProceduresPeripheral Arterial DiseaseRandomized Controlled Trials as TopicResearch DesignDelphi TechniqueFocus GroupsHumansPilot Projects

Identifiers

PMID40241414
PMCPMC12003854

What OpenQuestion holds

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LicenceCC BY
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.