Dexamethasone Infusion to the Adventitia to Enhance Clinical Efficacy After Femoropopliteal Revascularization

Completed · Not applicable

Conditions studied: Peripheral Arterial Disease

In brief

The purpose of this study is to test if dexamethasone, an anti-inflammatory medication approved by the US Food and Drug Administration (FDA), can be injected safely into the tissue around the blood vessel wall at the time of an angioplasty or atherectomy.

Key facts

Study ID

NCT01507558

Run by

University of California, San Francisco

People needed

22

Starts

2010-12-01

Expected to finish

2016-12-01

Last updated by the study team

2018-01-08

Who can join

Age: 40 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient is > 40 years and < 80 years of age
• Patient has severe, lifestyle-limiting claudication or critical limb ischemia (Rutherford classification 3-6)
• Patient has TASC II A, B or C disease, SFA revascularization is preferred over medical management, and endovascular approach is preferred revascularization strategy
• Patient has a resting ABI of <0.9 or an abnormal treadmill ABI. Patients with incompressible arteries must have a TBI <0.8
• Patient has at least 1 infra-popliteal run-off vessel with patency to the ankle without a >50% stenosis
• Successful crossing of the lesion with guidewire and successful atherectomy or angioplasty with residual stenosis <30% as compared to the reference vessels
• Atherectomy procedure does not result in embolization, arteriovenous fistula or perforation
• Patient agrees to return for a clinical assessment duplex ultrasound at 1, 3, 6, 9, 12 and 24 months (routine clinical care)

You may not qualify if…

• Patient is simultaneously participating in another investigational drug or device study
• Patient is pregnant or breast-feeding
• Patient has cancer, autoimmune disease, bone marrow or organ transplant, or other concurrent medical illness requiring immunosuppressive therapy
• Patient has end-stage renal disease and chronic kidney disease (eGFR<30)
• Patient has an active infection
• Patient has a known hypersensitivity or contraindication to heparin, contrast agents, excipients of Dexamethasone Sodium Phosphate Injection, USP, dexamethasone, or other glucocorticoids
• Patient has a life expectancy of less than one year

Where it is running

• San Francisco VA Medical Center — San Francisco, California, United States
• University of California, San Francisco Medical Center — San Francisco, California, United States

Full record on ClinicalTrials.gov

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