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

Stopped early

Conditions studied: Peripheral Arterial Disease

In brief

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.

Key facts

Study ID

NCT02037113

Run by

Texas Tech University Health Sciences Center

People needed

8

Starts

2014-01-01

Expected to finish

2016-08-01

Last updated by the study team

2018-03-21

Who can join

Age: 25 and older, up to 89. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 25-89 years of age
• Admitted for elective abdominal aortograms with runoff.
• Underwent Angioplasty and/or atherectomy with stent placement for Femoro-popliteal disease.
• Intravascular ultrasound was performed after stent deployment.

You may not qualify if…

• Patients who had prior Femoro-popliteal artery surgery or bypass in the same limb.
• Stent placement for lesions above inguinal ligament or below popliteal artery.
• The patient who presented with acute limb ischemia.
• Unable to follow-up in TTUHSC clinic.

Where it is running

• Texas Tech University Health Sciences Center — Lubbock, Texas, United States

Full record on ClinicalTrials.gov

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