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The CLTI Paradigm Shift: Implications for Clinical Trial Design and Endpoints in Endovascular Management of

Jihad A Mustapha1, Rita Jacob2, Larry E Miller3

  • 1Lake City Cardiovascular Institute, Lake City, FL, USA.

Journal of Endovascular Therapy : an Official Journal of the International Society of Endovascular Specialists
|August 28, 2025
PubMed

Insights

Traditional clinical trial endpoints for chronic limb-threatening ischemia (CLTI) are insufficient. A modified clinically-driven target lesion revascularization (CD-TLR) definition is proposed to better reflect patient outcomes and modern CLTI management.

Area of Science:

  • Vascular Surgery
  • Clinical Trials
  • Patient-Centered Outcomes

Background:

  • Critical limb ischemia (CLI) has evolved into chronic limb-threatening ischemia (CLTI), necessitating updated clinical trial metrics.
  • Traditional endpoints like hemodynamic indices and lesion patency fail to capture the complexity of CLTI or patient-centered outcomes.
  • Current assessment methods may not adequately inform clinical decision-making for CLTI management.

Purpose of the Study:

  • To explore the limitations of conventional endpoints used in CLTI clinical trials.
  • To propose a modified definition of clinically-driven target lesion revascularization (CD-TLR) that incorporates inflow, target lesion, and outflow disease.
  • To enhance the clinical relevance of trial results by aligning them with modern CLTI management strategies.

Main Methods:

  • Review of existing literature on CLTI endpoints.
  • Analysis of the shortcomings of traditional hemodynamic indices and lesion patency measures.
  • Development of a modified CD-TLR definition focusing on comprehensive vascular assessment and patient-relevant outcomes.

Main Results:

  • Conventional endpoints inadequately reflect CLTI complexity and patient-centered outcomes.
  • A modified CD-TLR definition offers a more comprehensive assessment of vascular health.
  • Prioritizing patient-relevant outcomes like limb salvage, wound healing, and function is crucial.

Conclusions:

  • The evolution of CLI to CLTI demands a reevaluation of clinical trial endpoints.
  • A modified CD-TLR definition better aligns with contemporary CLTI management.
  • Emphasizing patient-centered outcomes over surrogate endpoints improves clinical decision-making and CLTI care.

Keywords:
CD-TLRCLTIPADchronic limb-threatening ischemiaperipheral artery disease

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