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Clinical Trial Design and Considerations for Below-the-Knee Interventions and Amputation Prevention 

December 10, 2021
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MMI’s peripheral vascular experts discuss imaging assessments for evaluating structural and functional changes in vessels.

Key Highlights

  • CLTI – Understanding the disease, demographics and cost of amputation: socially and financially
  • Tibial / BTK clinical trials – why they are important, current market interests, clinical studies and study design
  • Trial infrastructure – core lab and imaging requirements

There are more than 200 million people living with peripheral artery disease (PAD) worldwide. Chronic Limb-Threatening Ischemia (CLTI) represents the most advanced clinical condition among the spectrum of PAD. CLTI is a highly morbid disease, associated with severe pain, ulcers and gangrene, impaired quality of life, amputations and mortality with a greater than $1 billion dollars healthcare cost per year. There are a number of evolving technologies in pharmaceuticals, devices and biologics which offer new opportunities in the diagnosis and treatment of CLTI.

Imaging plays an important role in the design of such clinical trials, as selecting the appropriate modalities, assessments, and endpoints are critical. Imaging can be leveraged in the subject selection process to identify appropriate patient management and to stratify patient populations that are appropriate for a trial. Imaging assessments must be designed to evaluate the appropriate functional and structural changes in the target vessel(s).

During this presentation, originally hosted as a virtual Xtalks webinar, our partners at InRoad Medical, Dr. Peter Schneider, MD, and Dr. David Deaton, MD, provide an overview of CLTI, an understanding to the social and financial cost, and a breakdown of the various procedures and technologies available for its evaluation and management. Additionally, a review is provided of various clinical trials to date, including common imaging modalities for evaluation of CLTI and study endpoints. MMI’s own Daniel Auger, PhD, then joins to discuss the clinical trial infrastructure for this type of study from an independent core lab’s perspective, including image and data management topics, as well as the importance of properly monitoring sites for imaging protocol compliance and image quality throughout a trial’s lifespan.

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