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Multi-Center Registry for Peripheral Arterial Disease Interventions and Outcomes
NCT01904851 · View on ClinicalTrials.gov ↗
Study Summary
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: 1. 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) 2. 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) 3. 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 t
Conditions Studied
Study Locations (20)
Texas
- Seton Heart Institute/ UT Austin — Austin
- Cardiothoracic and Vascular Surgeons — Austin
- Christus Sphon Hospital Corpus Christi-Shoreline — Corpus Christi
- North Texas Veteran Affairs Medical Center — Dallas
Ohio
- Cleveland Clinic — Cleveland
- Harrington Heart and Vascular Institute, University Hospitals — Cleveland
Oklahoma
- Oklahoma University Health Science Center — Oklahoma City
- Integris Heart Hospital — Oklahoma City
Arkansas
- Arkansas Heart Institute — Little Rock
Colorado
- Denver VAMC — Denver
Georgia
- Emory University — Atlanta
Illinois
- Loyola University Medical Center — Chicago
Indiana
- Indiana University Health Ball Memorial Hospital — Muncie
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14,000 participants |
| Start Date | 2013-01 |
| Est. Completion | 2033-01 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01904851
The ClinicalTrials.gov registry entry for NCT01904851 describes a study currently listed as recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 14,000 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Baylor Research Institute, which has 65 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Peripheral Arterial Disease appearing as the primary indexed condition, and to 0 interventions. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01904851 reports 20 study locations spanning 15 distinct geographic areas — top geographies include Texas, Ohio, Oklahoma. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT01904851 about?
NCT01904851 is a clinical study titled "Multi-Center Registry for Peripheral Arterial Disease Interventions and Outcomes". 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 ava...
What is the current status of trial NCT01904851?
This trial is currently recruiting. The enrollment target is 14,000 participants. The study started on 2013-01. Estimated completion is 2033-01.
What conditions does trial NCT01904851 study?
This clinical trial studies the following conditions: Peripheral Arterial Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
Who is sponsoring clinical trial NCT01904851?
This trial is sponsored by Baylor Research Institute, which has 65 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01904851 being conducted?
This trial has 20 study locations across Arkansas, Colorado, Georgia, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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