Dexamethasone Infusion to the Adventitia to Enhance Clinical Efficacy After Femoropopliteal Revascularization (DANCE)
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|ClinicalTrials.gov Identifier: NCT01507558|
Recruitment Status : Completed
First Posted : January 11, 2012
Last Update Posted : January 8, 2018
|Condition or disease||Intervention/treatment||Phase|
|Peripheral Arterial Disease||Procedure: Administration of dexamethasone to SFA/popliteal adventitia||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Dexamethasone Infusion to the Adventitia to Enhance Clinical Efficacy After Femoropopliteal Revascularization|
|Study Start Date :||December 2010|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||December 2016|
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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:||Warren J. Gasper, M.D.||University of California, San Francisco|