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Excellence In Peripheral Artery Disease

XLPAD is an observational study designed to evaluate the effectiveness and use of stent and non-stent based therapies among peripheral artery disease (PAD) patients

The study will create a registry that will include entry of procedural and clinical follow-up information into an online data collection software, REDCap.

 

XLPAD is an approved CMS Quality Registry

 

Objectives

  • Compare stent and non-stent based outcomes defined as a composite of symptom driven target vessel revascularization (TVR), unplanned surgical revascularization of the target limb and need for target limb amputation through 12 months post-index procedure (Primary efficacy endpoint)
  • Compare stent and non-stent based outcomes defined as a composite of causes such as: death, myocardial infarction (MI), stroke, peri-procedural complications, target vessel revascularization (TVR) and unplanned surgical revascularization/amputation of the target lib through 12 months (Primary safety endpoint)
  • Compare stent and non-stent based change in walking distance, Rutherford category and/or ankle-brachial index (ABI) at 12 months compared to baseline (Primary clinical improvement endpoint)  

Design

Approximately 14,000 patients will be enrolled at approximately 20 sites worldwide. Enrollment in the observational study will be monitored in an effort to achieve at least 20% (and no more than 80%) of the population receiving stents as the initial treatment strategy. Follow-up visits by sites will be reported at 6 and 12 months after index procedure to collect data on treatment patterns and effectiveness, and outcomes. The follow-up procedures are not mandated by the registry protocol. Each site will be encouraged to enter follow-up information derived from clinically indicated follow-up visits. All events post-index procedure till the 7th month will be reported under the 6 month follow-up form and subsequent follow-up till the 13th month post-procedure will be entered on the 12 month follow-up form. 

Treatment

Patient management and treatment decisions are at the discretion of the care team per routine clinical practice. The procedural aspects (including selection of stent type or non-stent based treatments) and follow-up are not mandated by the registry and will be up to the discretion of the operator and/or based upon the practice dictated by the clinical care of the patient. Therefore the study poses minimal risk to the patient

Investigators

Publications

Subhash Banerjee, MD, FACC, FSCAI
Principal Investigator

As a board-certified interventional cardiologist, Dr. Banerjee is internationally recognized for his expertise in minimally invasive treatments of coronary artery disease, peripheral artery disease and transcatheter aortic valve replacement. He is currently serving as the Paul J. Thomas Endowed Chair in Cardiology and chief of cardiovascular research and innovation for Baylor Scott & White Heart and Vascular Services-Dallas.

Dr. Banerjee is the editor-in-chief of the American Journal of Cardiology, one of the premier cardiology journals in the world. He also serves as one of the founding directors of the Cardiovascular Innovations Foundation. He has led many landmark clinical trials, published over 450 peer-reviewed manuscripts, and is an invited faculty at national and international cardiovascular conferences.

More about Dr. Banerjee

Investigators

Publications

Chadi Alraies, MD, MPH

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Publications

Lawrence Ang, MD

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Publications

Christopher Metzger, MD

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Publications

Peter Monteleone, MD

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Publications

Aravinda Nanjundappa, MD

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Publications

Mehdi Shishehbor, DO, MPH, PhD

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Publications

Shirling Tsai, MD

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Research coordinators

Publications

David Fernandez Vazquez, MD

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Publications

Sarah Weideman, BS

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Blake Bruneman, BS

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Core lab adjudication

Publications

Sarah Weideman, BS

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Biostatistical analysis team

Publications

Mufaddal Mamawala, MBBS, MPH, CPH

Biostatistician II - Baylor Scott & White Research Institute

Publications

Johanna Van Zyl, PhD

Biostatistician II - Baylor Scott & White Research Institute

Bertis Little, MA, PhD

 

Scott Novak, PhD

 

Independent data monitoring and clinical adjudication team

  • Richard Miller, MD
  • Shirling Tsai, MD
  • Shuaib Abdullah, MD
  • Oladipupo Olafiranye, MD
  • Bertis Little, MA, PhD
  • Rick Weideman, PharmD
  • David Jacob, PharmD

Sites

Active Sites and Investigators

Baylor Scott & White Research Institute, Dallas, TX Subhash Banerjee, MD

VA North Texas Health Care System, Dallas, TX Shirling Tsai, MD

Cleveland Clinic, Cleveland, OH Arvinda Nanjundappa, MD

Wellmont CVA Heart Institute, Kingsport, TN Gaurav Rana, MD

UC San Diego, San Diego, CA Lawrence Ang, MD

Ascension Seton / UT Austin, Austin, TXPeter Monteleone, MD

Detroit Medical Center (Wayne State), Detroit, MI Chadi Alraies, MD

Case Western (Cleveland Medical Center HHVI), OH Mehdi Shishehbor, DO, MPH, PhD

Contributing Sites and Investigators

CHRISTUS Health, Irving, TX Srikant Damaraju, MD

Denver VA Medical Center, Denver, CO Ehrin Armstrong, MD

Integris Hospital, Edmond, OK George Chrysant, MD

Midwest Cardiovascular Research Foundation, Davenport, IA Nicolas Shammas, MD

North Dallas Research Associates, McKinney, TX Muhammad Khan, MD

Boston VA Medical Center, Boston, MA Scott Kinlay, MD

Oklahoma University Health Sciences Center/ VA Oklahoma Medical Center, Oklahoma, OK Beau Hawkins, MD

UT Health Science Center, San Antonio, TX Anand Prasad, MD

Emory University, Atlanta, GA Kushrow A.K. Niazi, MD

Einstein Healthcare, Philadelphia, PA Sahil Banka, MD

Carolina East Health System, New Bern, NC David Jessup, MD

Tampa VA Medical Center, Tampa, FL James Brooks, MD

East Tennessee State University, Johnson City, TN Timir Paul, MD

Study Executive Committee

Publications

Subhash Banerjee, MD, FACC, FSCAI

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Publications

John Eidt, MD

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Publications

David Fernandez Vazquez, MD

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Publications

Christopher Metzger, MD

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Publications

Aravinda Nanjundappa, MD

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Publications

Zachary Rosol, MD

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Publications

Sameh Sayfo, MD

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Publications

Mehdi Shishehbor, DO, MPH, PhD

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Publications

Shirling Tsai, MD

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Recent Publications

  • Tsai S, Liu Y, Hoang L, et al. Comparative Outcomes of Interventions for Femoropopliteal Chronic Total Occlusion Versus Non-Chronic Total Occlusion Lesions From the Multicenter XLPAD Registry. J Am Heart Assoc. 2023;12(12):e028425. doi:10.1161/JAHA.122.028425
  • Soney H, Kakkilaya A, Vazquez DF, et al. Reproducibility of Femoropopliteal Artery Intravascular Ultrasound Imaging in Patients With Peripheral Artery Disease. Am J Cardiol. 2023;199:1-6. doi:10.1016/j.amjcard.2023.04.026
  • Meadors S, Klein A, Jeon-Slaughter H, et al. Short-Term Outcomes After Retrograde Versus Antegrade Crossing Approaches for Femoropopliteal Occlusive Disease. J Invasive Cardiol. 2023;35(1):E31-E36.
  • Vu MH, Sande-Docor GM, Liu Y, et al. Endovascular Treatment and Outcomes for Femoropopliteal In-Stent Restenosis: Insights from the XLPAD Registry. J Interv Cardiol. 2022;2022:5935039. Published 2022 Jul 15. doi:10.1155/2022/5935039
  • Kabir R, Vuppala S, Liu Y, et al. Clinical outcomes of patients with and without chronic kidney disease undergoing endovascular revascularization of infrainguinal peripheral artery disease: Insights from the XLPAD registry. Catheter Cardiovasc Interv. 2021;98(2):310-316. doi:10.1002/ccd.29491
  • Giannopoulos S, Jeon-Slaughter H, Kahlon RS, et al. Comparative 12-Month Outcomes of Drug-Coated Balloon Versus Non-Drug-Coated Balloon Revascularization Strategy in Chronic Limb-Threatening Ischemia: Results From the XLPAD Registry. Cardiovasc Revasc Med. 2020;21(10):1276-1284. doi:10.1016/j.carrev.2020.03.030
  • Armstrong EJ, Jeon-Slaughter H, Kahlon RS, Niazi KA, Shammas NW, Banerjee S. Comparative Outcomes of Supera Interwoven Nitinol vs Bare Nitinol Stents for the Treatment of Femoropopliteal Disease: Insights From the XLPAD Registry. J Endovasc Ther. 2020;27(1):60-65. doi:10.1177/1526602819885652
  • Banerjee S, Jeon-Slaughter H, Armstrong EJ, et al. Clinical Outcomes and Cost Comparisons of Stent and Non-Stent Interventions in Infrainguinal Peripheral Artery Disease: Insights From the Excellence in Peripheral Artery Disease (XLPAD) Registry. J Invasive Cardiol. 2019;31(1):1-9.
  • Khalili H, Jeon-Slaughter H, Armstrong EJ, et al. Atherectomy in below-the-knee endovascular interventions: One-year outcomes from the XLPAD registry. Catheter Cardiovasc Interv. 2019;93(3):488-493. doi:10.1002/ccd.27897

Research Electronic Data Capture (REDCap)

Online datasheet and database

All data points will be entered through the online data entry form provided by the REDCap software.

The REDCap software provides a wide array of tools to conveniently analyze data, generate reports, import/export datasheets, and collaborate on data with your research team.

The data can be exported directly into an excel spreadsheet as well as into many of the most widely used statistical software packages such as SAS, SPSS, and STATA.

Download the XLPAD manual for information on how to access the REDCap registry
Download manual