Arterial Imaging of Inflammation and Resolution After Endovascular Surgery (NCT03590769) | Clinical Trial Compass
CompletedPhase 1
Arterial Imaging of Inflammation and Resolution After Endovascular Surgery
United States9 participantsStarted 2017-06-01
Plain-language summary
This study evaluates the local inflammatory and resolution response of patients undergoing peripheral vascular intervention like an angioplasty of the superficial femoral artery (SFA) or popliteal artery, or stenting of the iliac artery or SFA, through the use of Positron emission tomography-magnetic resonance imaging (PET/MRI). PET/MRI will be performed prior to intervention, one day and one week after intervention.
Who can participate
Age range
40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Over the age of 40,
* With resting or exercise ABI \<0.9, TBI \<0.6
* Have claudication or limb threatening ischemia \& planning to undergo a percutaneous angioplasty of SFA or popliteal artery, or stenting of the iliac artery or SFA.
Exclusion Criteria:
* Evidence of active infection
* Hypersensitivity or allergy to contrast agents
* Chronic liver disease, renal disease (GFR\< 30) or chronic inflammatory disorders
* Insulin dependent diabetes
* Presence of metal within subject's body, pacemakers, or defibrillators
* BMI \< 20 or \>35
* Recent other major surgery or illness within 30 days
* Use of immunosuppressive medications or steroids
* History of organ transplantation
* Pregnancy, or plans to become pregnant, or lactating
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Changes found in the quantitative measure of FDG-PET uptake at intervention site prior to and after peripheral vascular injury.