Overview

This trial is active, not recruiting.

Condition peripheral arterial disease
Sponsor Texas Tech University Health Sciences Center
Start date January 2014
End date December 2017
Trial size 8 participants
Trial identifier NCT02037113, L14-047

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Patient who underwent angioplasty and/or atherectomy with stent placement for Femoro-popliteal disease and Intravascular ultrasound was performed after stent deployment.

Primary Outcomes

Measure
In Stent Restenosis
time frame: 1 years
Redo procedure
time frame: 1 year
Early and late stent thrombosis
time frame: 1 year
Acute ischemic event
time frame: 1 year

Secondary Outcomes

Measure
All causes mortality
time frame: 1 year

Eligibility Criteria

Male or female participants from 25 years up to 89 years old.

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.

Additional Information

Official title Outcomes of Femoro-popliteal Disease After Stent Deployment Under Intravascular Ultrasound Guidance (CRI14-007)
Principal investigator Alex Suarez, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Texas Tech University Health Sciences Center.