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

Outcomes of Femoro-popliteal Disease After Stent Deployment Under Intravascular Ultrasound Guidance (CRI14-007)

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02037113
Acronym
IVUS-PAD
Enrollment
8
Registered
2014-01-15
Start date
2014-01-31
Completion date
2016-08-31
Last updated
2018-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral Arterial Disease

Keywords

IVUS, PAD, Femoro-popliteal disease, Intravascular ultrasound

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.

Interventions

None listed

Sponsors

Texas Tech University Health Sciences Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
25 Years to 89 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
In Stent Restenosis1 years
Redo procedure1 year
Early and late stent thrombosis1 year
Acute ischemic event1 year

Secondary

MeasureTime frameDescription
All causes mortality1 yearto be obtained from UMC Cath-Lab NCDR registry

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026