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
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Condition or disease | Intervention/treatment | Phase |
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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 |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |

Arm | Intervention/treatment |
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Experimental: Intervention
Perivascular administration of dexamethasone following endovascular superficial femoral and popliteal artery angioplasty or atherectomy.
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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.
Other Names:
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- 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

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Ages Eligible for Study: | 40 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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 |
Responsible Party: | Warren J. Gasper, MD, MD, University of California, San Francisco |
ClinicalTrials.gov Identifier: | NCT01507558 |
Other Study ID Numbers: |
10-02101 |
First Posted: | January 11, 2012 Key Record Dates |
Last Update Posted: | January 8, 2018 |
Last Verified: | January 2018 |
Peripheral Arterial Disease Femoral popliteal lesions |
Peripheral Arterial Disease Peripheral Vascular Diseases Atherosclerosis Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases Dexamethasone Dexamethasone acetate BB 1101 Anti-Inflammatory Agents Antiemetics |
Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |