Peripheral Arterial Disease Clinical Trial
— DANCEOfficial title:
Dexamethasone Infusion to the Adventitia to Enhance Clinical Efficacy After Femoropopliteal Revascularization
Verified date | January 2018 |
Source | University of California, San Francisco |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 22 |
Est. completion date | December 2016 |
Est. primary completion date | December 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 80 Years |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | San Francisco VA Medical Center | San Francisco | California |
United States | University of California, San Francisco Medical Center | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Francisco |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety Outcome Measures: | Freedom from death, vessel dissection, thrombosis or extravasation at 30 days post-procedure. | 30 days | |
Primary | Effectiveness Outcome Measures: | Freedom from Target Lesion Revascularization (TLR) and/or Target Vessel Revascularization (TVR) at 6 months post-procedure. | 6 months | |
Secondary | Safety Outcome Measures: | Freedom from death, stroke, myocardial infarction, emergent surgical revascularization, significant distal embolization in target limb, and thrombosis of target vessel | 24 months |
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