Optimal Stent Selection for the Femoropopliteal Artery (SFA stent)
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|ClinicalTrials.gov Identifier: NCT02602145|
Recruitment Status : Recruiting
First Posted : November 11, 2015
Last Update Posted : March 5, 2020
|Condition or disease||Intervention/treatment|
|Femoropopliteal Stenting||Other: follow-up CTA|
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.
|Study Type :||Observational|
|Estimated Enrollment :||40 participants|
|Official Title:||Optimal Stent Selection for the Femoropopliteal Artery|
|Study Start Date :||December 2014|
|Estimated Primary Completion Date :||October 31, 2024|
|Estimated Study Completion Date :||October 31, 2024|
Peripheral artery disease patients
Patients with peripheral artery disease that were treated with a stent as part of their standard of care. Patients who meet the inclusion criteria (i.e. already have an SFA stent) will be consented after their endovascular repair, and those who choose to participate in the study will be followed for six months. At six months a standard post-operative contrast-enhanced CTA of the lower extremities will be obtained to assess for restenosis.
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 standard post-operative contrast-enhanced CTA of the lower extremities at 6 months after stenting.
- Radius of the femoropopliteal artery lumen [ Time Frame: 6 months ]Radius of the femoropopliteal artery lumen will be measured using 6-montth follow-up CTA to assess narrowing of the artery after stent implantation.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02602145
|Contact: Jason MacTaggart, MDfirstname.lastname@example.org|
|Contact: Karen Taylor, BSNemail@example.com|
|Principal Investigator:||Alexey Kamenskiy, PhD||University of Nebraska|