Outcomes of Femoro-popliteal Disease After Stent Deployment Under Intravascular Ultrasound Guidance (CRI14-007)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- In Stent Restenosis
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 25 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
In Stent Restenosis
时间窗: 1 years
Redo procedure
时间窗: 1 year
Early and late stent thrombosis
时间窗: 1 year
Acute ischemic event
时间窗: 1 year
次要结局
- All causes mortality(1 year)