Femoropopliteal StentingSFANCT02602145
Optimal Stent Selection for the Femoropopliteal Artery
An observational study of Femoropopliteal Stenting, run by University of Nebraska at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Femoropopliteal Stenting
- What is being tested?
- follow-up CTA
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Sep 2014to 16 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with severe peripheral artery disease already treated with a stent.
Who may be able to join
- Subjects eligible for participating in this study are patients with severe PAD who have:
- endovascular repair of their femoropopliteal artery
- standard pre-operative contrast-enhanced thin-section CTA of the lower extremities
- intraoperative angiograms and blood pressure measurements proximal and distal to the stent during the endovascular repair
- no aneurysmal disease of the target femoropopliteal artery
- no prior open or endovascular repair of the target femoropopliteal artery (patients with re-interventions are not eligible)
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- at least 2 out of 3 patent crural outflow vessels
- life expectancy >6 months
- no iodinated contrast allergy
- creatinine less than 1.6 g/dL (unless on chronic dialysis, dialysis patients are eligible)
- no orthopedic prostheses in the region of interest
- ability to comply with 6-12-month follow-up contrast enhanced thin-section CTA
Who cannot join
- no endovascular repair of the femoropopliteal artery
- endovascular or open re-intervention in the target limb
- no pre-operative thin-section contrast-enhanced CTA of the target limb
- no intraoperative angiogram or blood pressure measurements proximal and distal to the stent
- aneurysmal disease of the target femoropopliteal artery
- less than 2 patent crural outflow vessels
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- life expectancy ≤ 6 months
- iodinated contrast allergy
- orthopedic prosthesis in the region of interest
- creatinine greater than 1.6 g/dL (unless dialysis patient, chronic dialysis patients are eligible)
- inability to comply with 6-12-month contrast-enhanced CTA follow-up requirement
- patient belongs to vulnerable population, i.e. pregnant women, prisoners, institutionalized individuals
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nebraska Medical Center
Omaha, Nebraska, 68198
About this study
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.
Read the 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
- Being tested
- follow-up CTA
- Keywords
- femoral, popliteal, stent, modeling, flexion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
follow-up CTAOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Peripheral artery disease patients | Patients with peripheral artery disease who were treated with a stent as part of their standard of care. Patients who meet the inclusion criteria (i.e. already have a stent in their femoropopliteal artery) will be consented after their endovascular repair, and those who choose to participate in the study will be followed for 6-12 months. During the follow-up, a post-operative contrast-enhanced CTA of the lower extremities will be obtained to assess for restenosis. Receives: Other: follow-up CTA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radius of the femoropopliteal artery lumen
Radius of the femoropopliteal artery lumen will be measured using follow-up CTA to assess narrowing of the artery after stent implantation.
Measured: 6-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2015 (estimated)
- Study start2 Sep 2014
- Primary completion16 Apr 2021
- Study completion16 Apr 2021
Why it stopped: Study team did not maintain IRB approval
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoropopliteal StentingStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Jason MacTaggart, MD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02602145
- Sponsor's protocol ID
- 0386-14-FB
- Other IDs
- 5R01HL125736-05
- Acronym
- SFA
- Status last verified
- Aug 2023
- First submitted
- 9 Nov 2015
- Last updated
- 29 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Stent Selection for the Femoropopliteal Artery
- ClinicalTrials.gov ID
- NCT02602145
- Acronym / sponsor ID
- SFA / 0386-14-FB
- Conditions
- Femoropopliteal Stenting
- Keywords
- femoral, popliteal, stent, modeling, flexion
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study team did not maintain IRB approval
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 2 Sep 2014 (actual)
- Primary completion
- 16 Apr 2021 (actual)
- Study completion
- 16 Apr 2021 (actual)
- First posted
- 11 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Peripheral artery disease patients | – | Other: follow-up CTAPatients with peripheral artery disease who were treated with a stent as part of their standard of care. Patients who meet the inclusion criteria (i.e. already have a stent in their femoropopliteal artery) will be consented after their endovascular repair, and those who choose to participate in the study will be followed for 6-12 months. During the follow-up, a post-operative contrast-enhanced CTA of the lower extremities will be obtained to assess for restenosis. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with severe peripheral artery disease already treated with a stent.
Key inclusion criteria (12 listed)
- Subjects eligible for participating in this study are patients with severe PAD who have:
Key exclusion criteria (12 listed)
- no endovascular repair of the femoropopliteal artery
- endovascular or open re-intervention in the target limb
- no pre-operative thin-section contrast-enhanced CTA of the target limb
- no intraoperative angiogram or blood pressure measurements proximal and distal to the stent
- aneurysmal disease of the target femoropopliteal artery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| follow-up CTAAll 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. | Other | Peripheral artery disease patients |
Primary outcome
Radius of the femoropopliteal artery lumen
Time frame: 6-12 months
Radius of the femoropopliteal artery lumen will be measured using follow-up CTA to assess narrowing of the artery after stent implantation.
Results and safety
The study was stopped early (reason given: Study team did not maintain IRB approval). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason MacTaggart, MD principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Femoropopliteal Stenting, run by University of Nebraska at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study team did not maintain IRB approval). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radius of the femoropopliteal artery lumen (time frame: 6-12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2023.