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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
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Alexey Kamenskiy PhD, University of Nebraska

Brief 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 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.

Condition or disease Intervention/treatment
Femoropopliteal Stenting Other: follow-up CTA

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 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.

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Other
Time Perspective: Prospective
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

Group/Cohort Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with severe peripheral artery disease already treated with a stent.
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 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

Information from the National Library of Medicine

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


Contacts
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Contact: Jason MacTaggart, MD 4025594395 jmactaggart@unmc.edu
Contact: Karen Taylor, BSN 4025593935 kttaylor@unmc.edu

Locations
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United States, Nebraska
University of Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198
Contact: Karen Taylor, BSN    402-559-3935    kttaylor@unmc.edu   
Contact: Gail Paulsen, BSN    4025593853    gpaulsen@unmc.edu   
Sponsors and Collaborators
University of Nebraska
National Institutes of Health (NIH)
Investigators
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Principal Investigator: Alexey Kamenskiy, PhD University of Nebraska
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Responsible Party: Alexey Kamenskiy PhD, Professor, University of Nebraska
ClinicalTrials.gov Identifier: NCT02602145    
Other Study ID Numbers: 386-14-FB
First Posted: November 11, 2015    Key Record Dates
Last Update Posted: March 5, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alexey Kamenskiy PhD, University of Nebraska:
femoral
popliteal
stent
modeling
flexion