CURRENT REGISTRY PARTICIPANT LOCATIONS

Baylor Scott & White Research Institute, Dallas, TX

VA North Texas Health Care System, Dallas, TX

Cleveland Clinic, Cleveland, OH

Wellmont CVA Heart Institute, Kingsport, TN

UC San Diego, San Diego, CA

Ascension Seton / UT Austin, Austin, TX

Detroit Medical Center (Wayne State), Detroit, MI

Case Western (Cleveland Medical Center HHVI), OH

OBJECTIVES

 

XLPAD is an observational study designed to evaluate the effectiveness and use of stent and non-stent based therapies among 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 The primary objectives of this observational registry study are to:

  • 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

STUDY ENDORSEMENTS

Dr. Shammas endorses XLPAD.
Dr. Brilakis on the Xlpad registry
Dr. Subhash Banerjee speaks about the Xlpad registry
Dr. Prasad speaks on Excellence in Peripheral Arterial Disease (XLPAD)