Optimal Stent Selection for the Femoropopliteal Artery
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | Any |
| Updated: | 10/13/2018 |
| Start Date: | December 2014 |
| End Date: | October 31, 2019 |
| Contact: | Jason MacTaggart, MD |
| Email: | jmactaggart@unmc.edu |
| Phone: | 4025594395 |
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 segment, undergo large deformations during flexion of the limb. In
our NIH application we propose to accurately measure these deformations using human cadavers
and build mathematical models of human femoropopliteal arteries 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.
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 segment, undergo large deformations during flexion of the limb. In
our NIH application we propose to accurately measure these deformations using human cadavers
and build mathematical models of human femoropopliteal arteries 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.
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 standard 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. Six months after stenting perform standard post-operative lower extremity CTA and
assess the amount of in-stent restenosis and changes to the arterial geometry.
In our NIH 1R01 HL125736-01 application 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.
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 standard 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. Six months after stenting perform standard post-operative lower extremity CTA and
assess the amount of in-stent restenosis and changes to the arterial geometry.
In our NIH 1R01 HL125736-01 application 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.
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 six-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-month contrast-enhanced CTA follow-up requirement
12. patient belongs to vulnerable population, i.e. pregnant women, prisoners,
institutionalized individuals
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