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

Study Overview
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Brief Summary
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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 To determine intravascular ultrasound parameters of stent deployment and outcomes of Femoro-popliteal Disease To determine clinical risk factors and outcomes of Femoro-popliteal Disease 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.

Detailed Description
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SUBJECT POPULATION: - The patients who have peripheral arterial disease and underwent elective abdominal aortograms with runoff with peripheral artery intervention in University Medical Center hospital, Lubbock Texas, during January 2014 to December 30, 2015. INCLUSION CRITERIA: 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. EXCLUSION CRITERIA: 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.

Official Title
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Outcomes of Femoro-popliteal Disease After Stent Deployment Under Intravascular Ultrasound Guidance (CRI14-007)

Conditions
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Peripheral Arterial Disease

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patient underwent PAD-Stent<br>Patient who underwent angioplasty and/or atherectomy with stent placement for Femoro-popliteal disease and Intravascular ultrasound was performed after stent deployment. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In Stent Restenosis |  | 1 years | 
| Redo procedure |  | 1 year | 
| Early and late stent thrombosis |  | 1 year | 
| Acute ischemic event |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All causes mortality | to be obtained from UMC Cath-Lab NCDR registry | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IVUS, PAD, Femoro-popliteal disease, Intravascular ultrasound