Status:
COMPLETED
Dexamethasone Infusion to the Adventitia to Enhance Clinical Efficacy After Femoropopliteal Revascularization
Lead Sponsor:
University of California, San Francisco
Conditions:
Peripheral Arterial Disease
Eligibility:
All Genders
40-80 years
Phase:
NA
Brief Summary
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 ve...
Detailed Description
This is an investigator-initiated, single-arm, external pilot study to assess the safety and feasibility of perivascular administration of dexamethasone following endovascular superficial femoral and ...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT01507558
Start Date
December 1 2010
End Date
December 1 2016
Last Update
January 8 2018
Active Locations (2)
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1
San Francisco VA Medical Center
San Francisco, California, United States, 94121
2
University of California, San Francisco Medical Center
San Francisco, California, United States, 94143