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

Life Sciences, Clinical Trials, Pharmaceutical Regulation, Pharmaceutical, Medical Device, Commercialization & HEOR, Medical Device Clinical Trials, Medical Device Safety and Regulation,
  • Friday, December 10, 2021

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 patients with PAD. CLTI is a highly morbid disease and 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. Mortality is exceeds that for many types of cancer. 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 imaging modalities, assessments, and endpoints are critical to conducting a successful study. Imaging can be leveraged as part of the subject selection process to identify the appropriate patient management and to stratify patient populations that are appropriate for a trial. Depending on the type of treatment, imaging assessments must be designed in order to evaluate the appropriate functional and structural changes in the vessel.

In the first half of this webinar, Dr. Peter Schneider and Dr. David Deaton will provide attendees with an overview of the disease, an understanding to the social and financial cost, and provide a breakdown of the various procedures and technologies available for the evaluation and management of CLTI. The first half of this presentation will further provide a review of various clinical trials to date, common imaging modalities for evaluation of CLTI and study endpoints. During the second half of the webinar, a speaker from Medical Metrics, Inc. (MMI) will discuss the clinical trial infrastructure for this type of study from an independent core lab’s perspective. MMI will discuss the requirements for an independent core lab for the image and data management, as well as the importance of properly monitoring sites for imaging protocol compliance and image quality throughout the trials.



Peter Schneider, MD, Founding Partner, InRoad Medical

Peter A. Schneider, MD, is a Founding Partner of InRoad Medical. He also serves as Professor of Surgery in the Division of Vascular & Endovascular Surgery at University of California San Francisco. Dr. Schneider received his MD from the Johns Hopkins School of Medicine and completed vascular surgery at the University of California, San Francisco.

Dr. Schneider was the founding member and chief of the Division of Vascular Surgery at Kaiser Permanente in Hawaii from 1994-2018. At Kaiser, he developed a Diabetic Limb Treatment Program and a surveillance program for patients with aneurysms and a registry for patients with carotid disease used for surveillance. He oversaw the development of the first endovascular operating room in the Kaiser healthcare system.

He has been a National or Site Principal Investigator on numerous clinical trials. Dr. Schneider is a Distinguished Fellow of the Society for Vascular Surgery and is the past president of Western Vascular Society and Vascular and Interventional Advances (VIVA). He has been invited to numerous national and international visiting professorships, served as director, faculty or course director for many specialty courses and performed revascularization procedures in more than a dozen countries. He authored “Endovascular Skills,” the 4th edition published in 2019, and has co-authored three other books on various aspects of vascular disease. He has developed several medical devices and holds numerous patents.

Message Presenter

David Deaton, MD, Founding Partner, InRoad Medical

Dr. Deaton received his MD from Duke University School of Medicine (’85), completed his surgical residency and research fellowship at the Hospital of the University of Pennsylvania (’92), and his vascular fellowship at UCLA (’94). Dr. Deaton has practiced in a variety of private and academic settings, most recently as Chief-Division of Vascular and Endovascular Surgery at MedStar Georgetown University Hospital in Washington, DC and as Director, Clinical Vascular Research and Founder and Medical Director, Vascular Non-Invasive Laboratory. Since 2013, he has served as Chief Medical Officer for Endologix and Chief Medical Officer for Syntactx (a CRO), in addition to consulting for a variety of start-up and established medical device companies. He is currently Adjunct Associate Professor of Surgery at the Perelman School of Medicine/University of Pennsylvania.

Deaton was deeply involved in the development of endovascular aortic therapy beginning with preclinical work in 1993 and contributed significantly to many interventional/endovascular techniques over the last 27 years. He was a leading investigator (most prolific and technically successful site) in the first US EVAR (EVT/Ancure bifurcated endograft) trial and provided primary FDA panel testimony for the first approved EVAR device in the United States in 1999. In addition, he devoted 10 years to the development of the first endovascular suturing device (Aptus endoanchor).

Dr. Deaton has held leadership positions in several vascular societies (SVS, PVSS, Chesapeake Vascular), most recently as Chairman of the Political Action Committee of the SVS. His interest in new translational vascular therapies resulted in >20 consulting relationships, multiple patents in endovascular aortic grafts and lower extremity revascularization techniques, and authorship on numerous peer and non-peer reviewed articles as well as vascular textbook chapters. Dr. Deaton has served as a speaker and faculty member at more than 175 meetings worldwide and featured on major media platforms throughout his career.

Message Presenter

Daniel Auger, PhD, Client Services Manager, Medical Metrics, Inc.

Dan received his engineering degrees in Biomedical (2006) and Electrical Engineering (2008) from the University of the Witwatersrand, Johannesburg South Africa, and completed his Ph.D. in Biomedical Engineering from the University of Cape Town in 2013. In a move to the USA in 2014, he worked at the University of Virginia as a Research Scientist developing and implementing algorithms for the analysis of cardiac MR data. Dan joined the MMI team in 2018 as a Client Services Manager. Dan’s role includes building strong and strategic relationships with his clients and consultants. He has over 12 years of medical imaging experience, and multiple cardiovascular MRI publications, he provides expert technical advisement in the management of client proposals and consultant opportunities. As part of his MMI portfolio, Daniel has been involved trials from first-in-human to post-market in a breadth of therapeutic areas, including cardiovascular and peripheral vascular.

Message Presenter

Who Should Attend?

This webinar will be of interest to those designing and running BTK clinical trials, with relevant job titles including:

  • Medical monitors
  • Clinical scientists
  • Trial managers

What You Will Learn

In this webinar, attendees will learn about:

  • 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

Xtalks Partners

Medical Metrics Inc.

Medical Metrics Inc. (MMI) is an experienced provider of medical imaging core laboratory services for multicenter clinical trials. MMI’s ISO 9001-certified services include imaging protocol development, medical image management, independent image review, and scientific consulting. With 20+ years of experience on hundreds of studies, MMI can support global trials ranging from early-phase feasibility to post-market surveillance across a range of therapeutic areas, including orthopedics, spine, neurology, cardiology, vascular and surgical interventions, ENT, and AI/ML technologies.

InRoad Medical

InRoad Medical is a medical vascular and health strategy consulting firm with deep expertise in medical device development and clinical trials. The company offers medical consulting, regulatory consulting, educational tools, and keynotes. Engagements include consultation to a wide range of companies from startups to publicly traded entities, professional organizations, and institutional training programs. InRoad specializes in strategic planning, CMO, coaching, regulatory, and Educational Content services for companies looking to seize market opportunities related to medical devices, digital health, healthcare, and investment initiatives.

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