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 range40 Years

SexALL

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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

What they're measuring

Changes found in the quantitative measure of FDG-PET uptake at intervention site prior to and after peripheral vascular injury.

Timeframe: 1 time each week for 3 weeks

Trial details

NCT IDNCT03590769

SponsorUniversity of California, San Francisco

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-09-03

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