NCT01904851 Multi-Center Registry for Peripheral Arterial Disease Interventions and Outcomes
| NCT ID | NCT01904851 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Baylor Research Institute |
| Condition | Peripheral Arterial Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 14,000 participants |
| Start Date | 2013-01 |
| Primary Completion | 2033-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 14,000 participants in total. It began in 2013-01 with a primary completion date of 2033-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Eligibility Criteria
Inclusion Criteria: * Underwent Endovascular Intervention * Treated Iliac, Common or Superficial Femoral, Popliteal, Peroneal, Anterior Tibial, or Posterior Tibial Arteries Exclusion Criteria: * Surgical Bypass
Contact & Investigator
Subhash Banerjee, MD
PRINCIPAL INVESTIGATOR
Baylor Research Institute
Frequently Asked Questions
Who can join the NCT01904851 clinical trial?
This trial is open to participants of all sexes, studying Peripheral Arterial Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT01904851 currently recruiting?
Yes, NCT01904851 is actively recruiting participants. Contact the research team at david.fernandezvazquez@bswhealth.org for enrollment information.
Where is the NCT01904851 trial being conducted?
This trial is being conducted at Little Rock, United States, Denver, United States, Atlanta, United States, Chicago, United States and 11 additional locations.
Who is sponsoring the NCT01904851 clinical trial?
NCT01904851 is sponsored by Baylor Research Institute. The principal investigator is Subhash Banerjee, MD at Baylor Research Institute. The trial plans to enroll 14,000 participants.