Peripheral Arterial Disease Clinical Trial
Official title:
Outcomes of Femoro-popliteal Disease After Stent Deployment Under Intravascular Ultrasound Guidance (CRI14-007)
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.
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.
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