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

Terminated

• Conditions: Peripheral Arterial Disease

• Registration Number: NCT02037113
• Lead Sponsor: Texas Tech University Health Sciences Center

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.

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-01-13
• Study First Submitted QC: 2014-01-13
• Study First Posted: 2014-01-15
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-19
• Last Update Posted: 2018-03-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
In Stent Restenosis	1 years
Redo procedure	1 year
Early and late stent thrombosis	1 year
Acute ischemic event	1 year

Secondary Outcome Measures

Name	Time	Method
All causes mortality	1 year	to be obtained from UMC Cath-Lab NCDR registry

Trial Locations

Locations (1)

Texas Tech University Health Sciences Center; 🇺🇸 Lubbock, Texas, United States