Clinical trial NCT02037113: Outcomes of Femoro-popliteal Disease After Stent Deployment Under Intravascular Ultrasound Guidance
Official title: Outcomes of Femoro-popliteal Disease After Stent Deployment Under Intravascular Ultrasound Guidance (CRI14-007)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Peripheral Arterial Disease
Keywords: IVUS
PAD
Femoro-popliteal disease
Intravascular ultrasound
Lead sponsor: Texas Tech University Health Sciences Center
Sponsor class: OTHER
First posted: 2014-01-15
Enrollment: 8
Sex: ALL
Minimum age (years): 25
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study 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.

Brief 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: In Stent Restenosis
timeFrame: 1 years
measure: Redo procedure
timeFrame: 1 year
measure: Early and late stent thrombosis
timeFrame: 1 year
measure: Acute ischemic event
timeFrame: 1 year
Secondary outcomes:
measure: All causes mortality
timeFrame: 1 year
Other outcomes:
Locations:
city: Lubbock
country: United States
facility: Texas Tech University Health Sciences Center
state: Texas
Study officials:
affiliation: Texas Tech University Health Sciences Center
name: Alex Suarez, MD
role: PRINCIPAL_INVESTIGATOR
References:
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