Developing a framework for the design, conduct and reporting of trials for the endovascular treatment of peripheral arterial disease

Abstract

Endovascular technologies continue to evolve to address the growing burden of peripheral arterial disease (PAD). Rigorous evaluation of novel lower limb endovascular interventions is essential to ensure the adoption of effective technologies and rejection of those that are ineffective or harmful. This thesis aimed to systematically evaluate the quality of reporting in randomised controlled trials (RCTs) of endovascular PAD interventions and develop a framework to improve the design, conduct, and reporting of future clinical trials.

In the preliminary phase, the systematic review demonstrated that the overall quality of published RCTs in this field is low, creating uncertainty over treatment effectiveness.

This thesis consequently progressed through the design, development, and pilot testing of a novel framework, comprising four distinct phases. Phase 1 involved creating a preliminary framework using content analysis of interventions described in 112 published RCTs, reporting 228 endovascular procedures. Phase 2 used 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.

Content analysis identified six key themes for inclusion in the framework: (1) Expertise; (2) Setting; (3) Anaesthesia; (4) Imaging; (5) Intervention components (Access; Crossing lesion; Treating lesion: preparation, intervention, post-intervention treatment, bailout intervention, treatment of non-target lesions; Closure of artery); (6) Pharmacological interventions. Feedback from focus groups and the consensus questionnaire further refined the framework, while pilot-testing assessed comprehension, clarity and completeness.

The resulting Endo-STAR framework deconstructs endovascular interventions into key components and is designed to enhance the quality of RCTs of endovascular interventions in PAD. It provides a tool for developing future trial protocols, standardising infrainguinal endovascular procedures, monitoring adherence and supporting consistent reporting in clinical research.

Date of Award	20 Jan 2026
Original language	English
Awarding Institution	University of Bristol
Supervisor	Robert J Hinchliffe (Supervisor), Andrew J Moore (Supervisor), Ronelle Mouton (Supervisor) & Christopher Twine (Supervisor)