Multi-Center Registry for Peripheral Arterial Disease Interventions and Outcomes (XLPAD)
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|ClinicalTrials.gov Identifier: NCT01904851|
Recruitment Status : Recruiting
First Posted : July 22, 2013
Last Update Posted : May 19, 2020
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.Data available since Jan 1 2005 will be included in the registry, until 14,000 patients have been included. 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 limb 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)
Approximately 14,000patients will be enrolled at approximately 60 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.
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.
|Condition or disease|
|Peripheral Arterial Disease|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||14000 participants|
|Target Follow-Up Duration:||12 Months|
|Official Title:||Multi-Center Registry Comparing Stent and Non-Stent Based Interventional Outcomes for Patients With Peripheral Arterial Disease|
|Study Start Date :||January 2013|
|Estimated Primary Completion Date :||January 2033|
|Estimated Study Completion Date :||January 2033|
The patient received one or more stents to the superficial femoral, popliteal, peroneal, anterior tibial, or posterior tibial arteries in AT LEAST one of the lesions treated during the course of the procedure.
The patient did not receive a stent to the superficial femoral, popliteal, peroneal, anterior tibial, or posterior tibial arteries in ANY of the lesions treated during the course of the procedure.
- Target Limb Revascularization [ Time Frame: 12 months ]Target Lesion or Vessel Revascularization or Surgical Revascularization/Amputation of Target Limb
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01904851
|Contact: Ishita Tejani, BDS,MS,MSPHfirstname.lastname@example.org|
|Principal Investigator:||Subhash Banerjee, MD||University of Texas|