SFAOptimal Stent Selection for the Femoropopliteal Artery
Data Collection
Collected from today forward - ProspectiveOther
Utilizing specific methods not covered by standard models in order to address unique research questions.Summary
Study start date: September 2, 2014
Actual date on which the first participant was enrolled.This is an observational study of PAD patients that have already received SFA and PA stents as part of their standard of care. The purpose of this study is to determine the effects of Peripheral Artery Disease (PAD) stenting on the femoropopliteal artery. This will be achieved through the following Specific Aims: Aim 1. Evaluate pre-operative lower extremity CTAs of patients with PAD and determine the baseline arterial geometry and lesion characteristics. Aim 2. Evaluate the results of intraoperative angiography and blood pressure measurements proximal and distal to the stent. Aim 3. After stenting perform post-operative lower extremity CTA and assess the amount of in-stent restenosis and changes to the arterial geometry. We propose to build mathematical models of human femoropopliteal arteries repaired with several of the most commonly used PAD stents and assess the mechanical stress associated with limb flexion. These models will aim at predicting disease recurrence for arteries with different patient and lesion characteristics.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.5 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Other
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
Inclusion Criteria: * Subjects eligible for participating in this study are patients with severe PAD who have: 1. endovascular repair of their femoropopliteal artery 2. standard pre-operative contrast-enhanced thin-section CTA of the lower extremities 3. intraoperative angiograms and blood pressure measurements proximal and distal to the stent during the endovascular repair 4. no aneurysmal disease of the target femoropopliteal artery 5. no prior open or endovascular repair of the target femoropopliteal artery (patients with re-interventions are not eligible) 6. at least 2 out of 3 patent crural outflow vessels 7. life expectancy \>6 months 8. no iodinated contrast allergy 9. creatinine less than 1.6 g/dL (unless on chronic dialysis, dialysis patients are eligible) 10. no orthopedic prostheses in the region of interest 11. ability to comply with 6-12-month follow-up contrast enhanced thin-section CTA Exclusion Criteria: 1. no endovascular repair of the femoropopliteal artery 2. endovascular or open re-intervention in the target limb 3. no pre-operative thin-section contrast-enhanced CTA of the target limb 4. no intraoperative angiogram or blood pressure measurements proximal and distal to the stent 5. aneurysmal disease of the target femoropopliteal artery 6. less than 2 patent crural outflow vessels 7. life expectancy ≤ 6 months 8. iodinated contrast allergy 9. orthopedic prosthesis in the region of interest 10. creatinine greater than 1.6 g/dL (unless dialysis patient, chronic dialysis patients are eligible) 11. inability to comply with 6-12-month contrast-enhanced CTA follow-up requirement 12. patient belongs to vulnerable population, i.e. pregnant women, prisoners, institutionalized individuals
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
University of Nebraska Medical Center
Omaha, United StatesOpen University of Nebraska Medical Center in Google Maps