Excellence in Peripheral Artery Disease (XLPAD)

Sites Publicaciones REDCap Introducción Study Executive Committee Investigators

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.

Research Electronic Data Capture (REDCap)

Online datasheet and database

To enter the XLPAD study, you first need to go to the Baylor Scott & White Research Institute REDCap website https://redcap.bswhealth.org/.

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.

Investigators

Principal investigator

Subhash Banerjee, MD, FACC, FSCAI

Principal Investigator

View Dr. Banerjee's profile Dr. Banerjee's publications

Positions and Employment

2022: Paul J. Thomas Endowed Chair, Chief of CV Research & Innovation Baylor Scott & White Heart and Vascular Hospital
2014: Professor in Medicine, UT Southwestern Medical School
2010: Associate Professor in Medicine, UT Southwestern Medical School
2009: Chief, Division of Cardiology, VA North Texas Healthcare System
2008: Adjunct Professor in Bioengineering, University of Texas at Arlington
2004: Director, Cardiac Cath. Laboratory, Dallas VA Medical Center
2004: Assistant Professor in Medicine, UT Southwestern Medical School

Honors and Awards

2011: Cardiovascular Revascularization Leadership Award
2010: Young Leadership Award in Cardiology Cardiovascular Revascularization Therapy
2009: Cardiovascular Revascularization Leadership Award
2007: VA North Texas Healthcare System Courtesy in Action Award
2007: Emerging Cardiology Faculty Nomination American College of Cardiology
2006: American College of Cardiology Emerging Faculty Nomination
2003: Society for Cardiovascular Angiography and Interventions Honors
2003: Peak Performance Award
2003: Society for Cardiovascular Angiography and Interventions Honors
2001: American Federation of Medical Research Travel Award
2000: ACCF/Bristol Myers Squibb Affiliate Travel Award
2000: Post-Doctoral Fellowship Award American Heart Association
2000: American Heart Association Post-Doctoral Fellowship Award
1999: Outstanding Teacher Award, NY Hospital. Queens, Cornell University
1999: John Dwoek Teacher of the Year Award New York Hospital Medical Center. Queens Cornell University, NY
1998: Best Resident Award, NY Hospital. Queens, Cornell University
1997: Best Resident of the Year Award, NY Hospital. Queens, Cornell University
1992: Doctor of Medicine with Honors Minsk Medical Institute, Minsk
1992: Dean's List Minsk Medical Institute
1992: Doctor of Medicine with Honors, Deans recognition for top student
1986: Minsk medical Institute International Student Scholarship

Professional Associations and Affiliations

American College of Cardiology (FACC)t
American Heart Association
Society of Coronary Angiography and Interventions

Research Interests

Atherosclerotic Plaque Composition Imaging with Intravascular Ultrasound
Endothelial Progenitor Cell Mobilization
Peripheral Vascular Interventions
Saphenous Vein Graft Intervention

Investigators

Chadi Alraies, MD, MPH

Dr. Alraies' publications

Positions and Employment

2022: Deputy Editor & Detroit Hour Top Doc
2021: Medical Director of Cardiac Rehab, Detroit Medical Center
2021: Medical Director of Cardiac Catheterization Laboratory, Detroit Medical Center
2021: Assistant Clinical Professor of Medicine, Wayne State University School of Medicine
2020: Director of Interventional Cardiology Research, Detroit Medical Center

Educación

Medical School: Aleppo University, Aleppo, Syria
Internship/Residency: Case Western University/St. Vincent Medical Center, Cleveland, OH
Fellowship: (Cardiovascular Medicine) University of Minnesota, Minneapolis, MN;
(Interventional Cardiology) Wayne State University/Detroit Medical Center, Detroit, MI

Honors and Awards

Hour Detroit Magazine 2022 Top Doc

Professional Associations and Affiliations

American College of Cardiology
American Heart Association
Society for Cardiovascular Angiography & Interventions

Lawrence Ang, MD

Dr. Ang's publications

Positions and Employment

2017 - UC San Diego Health

Educación

Medical School: UC San Diego, School of Medicine, San Diego, CA
Residency: UC San Diego, School of Medicine, San Diego, CA
Fellowship: UC San Diego, School of Medicine, San Diego, CA
Fellowship: UC San Francisco, School of Medicine, San Francisco, CA

Certifications and Licenses

Interventional Cardiology, American Board of Internal Medicine
Cardiovascular Disease, American Board of Internal Medicine
CA State Medical License

Professional Associations and Affiliations

American College of Cardiology - ACCRegents of The University of California - UCSD Physician Assoc.
Regents of The University of California - UCSD Medical Group
UC San Diego Health System - Hillcrest
UC San Diego Medical Center - Hillcrest

Christopher Metzger, MD

Dr. Metzger's publications

Positions and Employment

Ballad Health’s System Chair of Clinical Research
Director of Holston Valley Medical Center’s diagnostic catheterization and interventional labs

Educación

Medical School: Marshall University Joan C. Edwards School of Medicine, Huntington, WV
Residency: Internal Medicine, Wake Forest University School of Medicine, Winston-Salem, NC
Fellowship: Cardiovascular Disease, Wake Forest University School of Medicine, Winston-Salem, NC

Honors and Awards

CMS Meaningful Use Stage 1 Certification - NextGen Ambulatory EHR, NextGen Healthcare, 2011-2013

Certifications and Licenses

VA State Medical License 1999 - 2024
TN State Medical License 1999 - 2023
SC State Medical License 1999 - 1999
NC State Medical License 1994 - 1999
American Board of Internal MedicineInterventional Cardiology

Professional Associations and Affiliations

Select Specialty Hospital Tri Cities, TN

Peter Monteleone, MD

Dr. Monteleone's publications

Afiliaciones hospitalarias

Ascension Seton Edgar B. Davis
Ascension Seton Hays
Ascension Seton Highland Lakes
Ascension Seton Medical Center Austin
Ascension Seton Northwest
Ascension Seton Smithville
Ascension Seton Southwest
Ascension Seton Williamson
Dell Seton Medical Center at The University of Texas

Educación

Medical School: Tufts University School of Medicine
Master's in Clinical Research: University of Virginia Graduate School of Arts and Sciences
Residency: University of Virginia Health Syste
Fellowship: Massachusetts General Hospital
Fellowship: Massachusetts General Hospital
Fellowship: Cleveland Clinic Foundation

Honors and Awards

Masters of Critical Limb Ischemia Conference Grant Cleveland Clinic, 2015
Interventional Cardiology Board Review (ICBR) Grant Mayo Clinic, 2014
Excellence in Teaching Award Cleveland Clinic, 2013-2014 Fellows-In-Training Conference Grant American College of Cardiology, 2013

Certifications and Licenses

The American Board of Internal Medicine - Cardiovascular Disease
The American Board of Internal Medicine - Interventional Cardiology

Professional Associations and Affiliations

Society of Coronary Angiography and Intervention 2015-Present
American Heart Association 2013-Present
Society of Vascular Medicine 2013-Present
American Medical Association 2003-Present
American College of Cardiology 2011-Present

Research Interests

Diagnostics, outcomes and novel device development in peripheral vascular and cardiovascular medicine

Aravinda Nanjundappa, MD

Dr. Nanjundappa's publications

Positions and Employment

2022 Cleveland Clinic

Educación

Medical School: Adichunchunagiri Institute of Medical Sciences, B.G.Nagara, India, 1994
Internship: Medicine, St. George's University General Hospital, St. George's, Grenada West Indies, 1995
Residency: Internal Medicine, Saint Michael's Medical Center, Newark, NJ, 2000
Fellowship: Cardiology, Saint Michael's Medical Center, Newark, NJ, 2003
Fellowship: Interventional Cardiology, Shands Medical Center at the University of Florida, Jacksonville, FL, 2004
Fellowship: Interventional Peripheral Vascular Fellowship, Medstar Washington Hospital Center, Washington, DC, 2005

Certifications and Licenses

Internal Medicine - Cardiovascular Disease
Internal Medicine - Interventional Cardiology

Mehdi Shishehbor, DO, MPH, PhD

Dr. Shishehbor's publications

Positions and Employment

2017: Co-Chair, Clinical Executive Committee, University Hospitals
2017: Co-Director, System Wide Vascular Center, University Hospitals
A2017: Director, System Wide Cardiovascular Interventional Center, University Hospitals
2008: Director, Endovascular Services, Cleveland Clinic

Educación

Doctor of Osteopathic Medicine: Nova Southeastern University, Fort Lauderdale, FL, 1995 - 1999
Master of Public Health: Northeast Ohio Medical University (NEOMED), Rootstown, OH, 2003 - 2004
Master of Public Health: Cleveland State University, Cleveland, OH, 2004 - 2005
Doctor of Philosophy: Epidemiology, Case Western Reserve University, Cleveland, OH, 2007 - 2012

Honors and Awards

National Institutes of Health KL-2 Award
Research Finalist at the American College of Cardiology and the American Heart Association Young Investigator Award Competitions
VIVA/LINC Young Leader's Award in Vascular, 2009
Thomas J. Linnemeier Spirit of Interventional Cardiology Young Investigator Award, 2008

Certifications and Licenses

The American Board of Internal Medicine - Cardiovascular Disease
The American Board of Internal Medicine - Interventional Cardiology

Professional Associations and Affiliations

Journal of American Medical Association
Journal of the American College of Cardiology and Circulation
American Journal of Cardiology
New England Journal of Medicine
Archives of Internal Medicine

Research Interests

Clinical outcomes in interventional cardiology, carotid and endovascular interventions
Novel minimally invasive percutaneous approaches to treat cardiac, venous and arterial diseases

Shirling Tsai, MD

Dr. Tsai's publications

Positions and Employment

Vascular Surgery, VA North Texas and UT Southwestern
Assistant Professor, Department of Surgery at UT Southwestern Medical Center

Educación

Medical School: Columbia University Vagelos College of Physicians and Surgeons, New York, NY, 1999-2003
General Surgery Residency: New York Presbyterian Hospital, New York, NY, 2003-2010
Research Fellowship: Weill Cornell Graduate School of Medical Science, OH, 2006- 2008, New York, NY
Vascular Surgery Fellowship: Massachusetts General Hospital, Boston, MA, 2010-2012

Honors and Awards

D Magazine Best Doctor 2022

Certifications and Licenses

The American Board of Internal Medicine - Cardiovascular Disease
The American Board of Internal Medicine - Interventional Cardiology

Professional Associations and Affiliations

Dallas VA Institutional Review Board (IRB)
American College of Surgeons
Society for Vascular Surgery
Association for Academic Surgery
American Heart Association
Association of VA Surgeons
Reviewer for the Journal of Vascular Surgery and the Annals of Vascular Surgery

Research Interests

Genetics of abdominal aortic aneurysms
Lipoprotein Receptor Signaling Mechanisms in Aortic Aneurysm
Parthenogenesis

Coordinators

David Fernandez Vazquez, MD

Dr. Vazquez's publications

Positions and Employment

Present - Research Project Coordinator 1 - Baylor Scott & White Research Institute, Dallas, TX
2022 - Clinical Research Coordinator 1 - Dallas VA Research Corporation, Dallas, TX
2021 – Clinical Cardiologist – Hospital Comarcal del Noroeste Caravaca de la Cruz, Murcia, Spain

Educación

Medical School: Facultad de Medicina, Universidad de Murcia, Spain, 2009
Residency: Cardiology, Hospital Universitario Virgen de la Arrixaca, Murcia, Spain, 2016
Masters degree: "Investigation in Clinical Medicine" Universidad Miguel Hernandez, Elche, Spain, 2017
Masters degree: "Advances in cardiology" Universidad Catolica de San Antonio Murcia, Spain, 2018

Certifications and Licenses

Adult Transthoracic Echocardiography – European Association of Cardiovascular Imaging
General Cardiology – European Society of Cardiology

Professional Associations and Affiliations

Spanish Society of Cardiology (SEC)
European Society of Cardiology (ESC)
American College of Cardiology

Research Interests

Peripheral vascular disease
Cardiovascular Imaging

Sarah Weideman, BS

Weideman's publications

Positions and Employment

Present - Research Project Coordinator I/Core Lab Analyst - Baylor Scott & White Research Institute
2022 - Clinical Research Coordinator I - Dallas VA Research Corporation

Educación

Bachelor of Science: Biology, Minor in Psychology and Social Sciences, Tarleton State University

Certifications and Licenses

Certified Electrocardiograph Technician - National Performance Specialists Certification Program

Abstracts/Publications

Sarah Weideman, BS, David Fernandez Vazquez, MD, Mufaddal Mamawala, MBBS, MPH, CPH,
Jazmyn Criss, BS, Akash Kakkilaya, BS, Zachary Rosol, MD; Subhash Banerjee, MD. Use of Intravenous
Ultrasound During Endovascular Treatment of Infrainguinal Peripheral Artery Chronic Total Occlusion in the
XLPAD Registry, Cardiovascular Innovations - The Operators Enclave, Poster Presentation, julio 19-22, 2023.
Sarah Weideman, David Fernandez Vazquez, Blake Bruneman, Aravinda Nanjundappa,Christopher Metzger, Sameh Sayfo, Zachary Rosol, Shirling Tsai, Mehdi H Shishehbor, Subhash Banerjee. Comparative Outcomes of Below-the-Knee Atherectomy Interventions: A Report From the XLPAD Registry, American Heart Association - Scientific Sessions, Poster Presentation, noviembre 13, 2023.
David Fernandez Vazquez, Sarah Weideman, Blake Bruneman, Talha Akram, Zachary Rosol, Sameh Sayfo, Aravinda Nanjundappa, Christopher Metzger, Shirling Tsai, Mehdi Shishehbor, Subhash Banerjee. Double or Nothing: Comparative Outcomes of Antiplatelet Regimens in Peripheral Artery Disease Endovascular interventions, a Report from the XLPAD Registry, TCT Call for Science, Oral Presentation, octubre 23-26, 2023.
Rahul Banerjee, Sarah Weideman, David Fernandez-Vazquez, Avantika Banerjee, Ahmed Hasan, Shirling Tsai. Role of Lipoprotein A in Lower Extremity Peripheral Artery Disease, The American Journal of Cardiology, Volume 198, 2023, Pages 47-49, ISSN 0002-9149, https://doi.org/10.1016/j.amjcard.2023.04.017. (https://www.sciencedirect.com/science/article/pii/S0002914923002357)

Research Interests

Cardiovascular imaging
Peripheral vascular disease

Blake Bruneman, BS

Positions and Employment

Research Intern - Baylor Scott & White Research Institute
Certified Nurse Assistant - Columbine Health Systems, Centre Ave

Educación

Bachelor of Science: Pre-Health Biology/Chemistry Minor, Colorado State University

Certifications and Licenses

Nurse Assistant

Core lab adjudication

Sarah Weideman, BS

Weideman's publications

Positions and Employment

Present - Research Project Coordinator I/Core Lab Analyst - Baylor Scott & White Research Institute
2022 - Clinical Research Coordinator I - Dallas VA Research Corporation

Educación

Bachelor of Science: Biology, Minor in Psychology and Social Sciences, Tarleton State University

Certifications and Licenses

Certified Electrocardiograph Technician - National Performance Specialists Certification Program

Abstracts/Publications

Sarah Weideman, BS, David Fernandez Vazquez, MD, Mufaddal Mamawala, MBBS, MPH, CPH,
Jazmyn Criss, BS, Akash Kakkilaya, BS, Zachary Rosol, MD; Subhash Banerjee, MD. Use of Intravenous
Ultrasound During Endovascular Treatment of Infrainguinal Peripheral Artery Chronic Total Occlusion in the
XLPAD Registry, Cardiovascular Innovations - The Operators Enclave, Poster Presentation, julio 19-22, 2023.
Sarah Weideman, David Fernandez Vazquez, Blake Bruneman, Aravinda Nanjundappa,Christopher Metzger, Sameh Sayfo, Zachary Rosol, Shirling Tsai, Mehdi H Shishehbor, Subhash Banerjee. Comparative Outcomes of Below-the-Knee Atherectomy Interventions: A Report From the XLPAD Registry, American Heart Association - Scientific Sessions, Poster Presentation, noviembre 13, 2023.
David Fernandez Vazquez, Sarah Weideman, Blake Bruneman, Talha Akram, Zachary Rosol, Sameh Sayfo, Aravinda Nanjundappa, Christopher Metzger, Shirling Tsai, Mehdi Shishehbor, Subhash Banerjee. Double or Nothing: Comparative Outcomes of Antiplatelet Regimens in Peripheral Artery Disease Endovascular interventions, a Report from the XLPAD Registry, TCT Call for Science, Oral Presentation, octubre 23-26, 2023.
Rahul Banerjee, Sarah Weideman, David Fernandez-Vazquez, Avantika Banerjee, Ahmed Hasan, Shirling Tsai. Role of Lipoprotein A in Lower Extremity Peripheral Artery Disease, The American Journal of Cardiology, Volume 198, 2023, Pages 47-49, ISSN 0002-9149, https://doi.org/10.1016/j.amjcard.2023.04.017. (https://www.sciencedirect.com/science/article/pii/S0002914923002357)

Research Interests

Cardiovascular imaging
Peripheral vascular disease

Biostatisticians

Mufaddal Mamawala, MBBS, MPH, CPH

Biostatistician II

Dr. Mamawala's publications

Johanna Van Zyl, PhD

Biostatistician II

Dr. Van Zyl's publications

Bertis Little, MA, PhD

Scott Novak, PhD

Independent data team

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, TX - Peter 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