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Outcomes of Femoro-popliteal Disease After Stent Deployment Under Intravascular Ultrasound Guidance

NCT02037113 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 8

Last updated 2018-03-21

No results posted yet for this study

Summary

This is a prospective, single-center study. The patients with peripheral arterial disease who underwent abdominal aortograms with runoff (which are arteriograms of the lower abdominal aorta and arteries in the legs) and Intravascular Ultrasound after stent deployment will be enrolled in the study. All patients who participated in the study will be treated according to standard of care.

HYPOTHESIS The higher degree of plaque burden on landing zone has an effect on restenosis on peripheral artery intervention.

SPECIFIC AIMS

1. To determine intravascular ultrasound parameters of stent deployment and outcomes of Femoro-popliteal Disease
2. To determine clinical risk factors and outcomes of Femoro-popliteal Disease
3. To obtain data that will eventually support development of a predictive model for ISR in Femoro-popliteal Disease

METHODOLOGY Visit 1: After consent is given

The subject will receive standard follow-up care. A member of the research team will collect information such as the subject's age, sex, ethnicity, and medical information from the subject's medical record.

Visits 2-5: 1 day after enrollment, and at months 3 (+- 2 weeks), 6 (+- 2 weeks), and 12 (+- 2 weeks)

The subject will complete standard follow-up appointment at TTUHSC. This may include a Doppler ultrasound.

A member of the research team will record information such as medications, ultrasounds, and need for additional care related to the subject's stent.

The subject will complete the questionnaire on leg pain and mobility.

Conditions

  • Peripheral Arterial Disease

Sponsors & Collaborators

  • Texas Tech University Health Sciences Center

    lead OTHER

Principal Investigators

  • Alex Suarez, MD · Texas Tech University Health Sciences Center

Eligibility

Min Age
25 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2016-08-31
Completion
2016-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02037113 on ClinicalTrials.gov