NCT02602145

Optimal Stent Selection for the Femoropopliteal Artery

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 5 (actual)
• Sponsor: University of Nebraska · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

Angioplasty and stenting for atherosclerotic occlusive disease in the arteries supplying the legs (Peripheral Arterial Disease, PAD) is the most common endovascular procedure outside of the heart, but carries the highest rate of reconstruction failure. The underlying reasons for these poor results are not completely clear, but the main arterial segment within the leg, the femoropopliteal artery, appears to be significantly different from other peripheral arteries because the Superficial Femoral Artery (SFA) and Popliteal Artery (PA) that comprise the femoropopliteal artery (FPA) segment, undergo large deformations during flexion of the limb. We propose to build mathematical models of human FPAs repaired with several frequently used PAD stents. These mathematical models would be able to assess the mechanical stress in the stented SFA and PA associated with limb flexion and predict disease recurrence for arteries with different patient and lesion characteristics. Results of model predictions will be validated in patients with PAD stents who have received these stents as part of their standard of care.

Detailed description

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.

Conditions

• Femoropopliteal Stenting

Interventions

Type	Name	Description
OTHER	follow-up CTA	All patients will receive PAD stents as their normal standard of care determined by their treating physician. If the patient would decide to enroll in the study, we will perform a post-operative contrast-enhanced CTA of the lower extremities at 6-12 months after stenting.

Timeline

• Start date: 2014-09-02
• Primary completion: 2021-04-16
• Completion: 2021-04-16
• First posted: 2015-11-11
• Last updated: 2023-08-29

Locations

1 site across 1 country: United States