Dexamethasone Infusion to the Adventitia to Enhance Clinical Efficacy After Femoropopliteal Revascularization (DANCE)
|Peripheral Arterial Disease||Procedure: Administration of dexamethasone to SFA/popliteal adventitia|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Dexamethasone Infusion to the Adventitia to Enhance Clinical Efficacy After Femoropopliteal Revascularization|
- Safety Outcome Measures: [ Time Frame: 30 days ]Freedom from death, vessel dissection, thrombosis or extravasation at 30 days post-procedure.
- Effectiveness Outcome Measures: [ Time Frame: 6 months ]Freedom from Target Lesion Revascularization (TLR) and/or Target Vessel Revascularization (TVR) at 6 months post-procedure.
- Safety Outcome Measures: [ Time Frame: 24 months ]Freedom from death, stroke, myocardial infarction, emergent surgical revascularization, significant distal embolization in target limb, and thrombosis of target vessel
|Study Start Date:||December 2010|
|Estimated Study Completion Date:||June 2017|
|Estimated Primary Completion Date:||June 2016 (Final data collection date for primary outcome measure)|
Perivascular administration of dexamethasone following endovascular superficial femoral and popliteal artery angioplasty or atherectomy.
Procedure: Administration of dexamethasone to SFA/popliteal adventitia
Following a balloon angioplasty or atherectomy of a stenotic TASC II A, B, or C lesion in the superficial femoral or popliteal artery, a Bullfrog Micro-Infusion Catheter will be used to infuse 0.96 mg dexamethasone per cm arterial lesion.
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 popliteal artery angioplasty or atherectomy.
Although dexamethasone is approved by the FDA for injection into blood, skin or joints, it has not been approved by the FDA for injection around blood vessels. The investigators want to find out if this procedure helps prevent re-narrowing of the blood vessel after angioplasty or atherectomy. The dexamethasone will be injected with a Bullfrog® Micro-Infusion catheter, which is an FDA-approved device for injecting medications into tissues around the blood vessel wall. The Bullfrog® Micro-Infusion catheter is similar to other balloon tipped catheters except that it contains a microneedle covered by a fold of semi-rigid balloon. Once the balloon is inflated, the microneedle is uncovered and a medication can be injected into the tissue around the blood vessel.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01507558
|United States, California|
|San Francisco VA Medical Center|
|San Francisco, California, United States, 94121|
|University of California, San Francisco Medical Center|
|San Francisco, California, United States, 94143|
|Principal Investigator:||Christopher D Owens, M.D., M.Sc||University of California, San Francisco|