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NCT01904851 · ClinicalTrials.gov registry record

Multi-Center Registry for Peripheral Arterial Disease Interventions and Outcomes

A clinical trial of Peripheral Arterial Disease, sponsored by Baylor Research Institute.

Recruiting
Registry status
14,000
Enrollment target
20
Study locations

NCT01904851 is a study of Peripheral Arterial Disease that is actively recruiting participants, run by Baylor Research Institute. The registered enrollment target is 14,000 participants, above the 4,029-participant average among 79 other Peripheral Arterial Disease trials with a reported enrollment target (247% higher). The trial reports 20 study locations across 15 states.

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The verdict

NCT01904851, a study of Peripheral Arterial Disease, is actively recruiting participants, sponsored by Baylor Research Institute.

RECRUITING
Registry status
14,000 participants
Enrollment target
20
Study locations

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

Peripheral Arterial Disease

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

FieldValue
Enrollment Target 14,000 participants
Start Date 2013-01
Est. Completion 2033-01

Sponsor

Baylor Research Institute

180 total trials

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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, categorized as an unspecified phase. The registered enrollment target is 14,000 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 4,029-participant average among 79 other Peripheral Arterial Disease trials with a reported enrollment target (247% higher). The listed sponsor is Baylor Research Institute, which has 180 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Peripheral Arterial Disease appearing as the primary indexed condition, and to 0 interventions.

NCT01904851 reports 20 study locations spanning 15 distinct geographic areas - top geographies include Texas, Ohio, Oklahoma.

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.

Who is sponsoring clinical trial NCT01904851?

This trial is sponsored by Baylor Research Institute, which has 180 total clinical trials registered on ClinicalTrials.gov.

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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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.