Dexamethasone Infusion to the Adventitia to Enhance Clinical Efficacy After Femoropopliteal Revascularization (DANCE)

Study Description

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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 vessel wall at the time of an angioplasty or atherectomy.

Condition or disease	Intervention/treatment	Phase
Peripheral Arterial Disease	Procedure: Administration of dexamethasone to SFA/popliteal adventitia	Not Applicable

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 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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	22 participants
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

Arms and Interventions

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Arm

Intervention/treatment

Experimental: Intervention; 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.; Other Names: angioplasty; atherectomy; TASC II A, B, C lesion; dexamethasone; superficial femoral artery; popliteal artery

Outcome Measures

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Primary Outcome Measures :

1. Safety Outcome Measures: [ Time Frame: 30 days ]
   Freedom from death, vessel dissection, thrombosis or extravasation at 30 days post-procedure.
2. Effectiveness Outcome Measures: [ Time Frame: 6 months ]
   Freedom from Target Lesion Revascularization (TLR) and/or Target Vessel Revascularization (TVR) at 6 months post-procedure.

Secondary Outcome Measures :

1. 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

Eligibility Criteria

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

Criteria

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

Contacts and Locations

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Locations

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

Sponsors and Collaborators

University of California, San Francisco

Investigators

Principal Investigator:	Warren J. Gasper, M.D.	University of California, San Francisco

More Information

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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Owens CD, Gasper WJ, Walker JP, Alley HF, Conte MS, Grenon SM. Safety and feasibility of adjunctive dexamethasone infusion into the adventitia of the femoropopliteal artery following endovascular revascularization. J Vasc Surg. 2014 Apr;59(4):1016-24. doi: 10.1016/j.jvs.2013.10.051. Epub 2014 Jan 11.

Responsible Party:	Warren J. Gasper, MD, MD, University of California, San Francisco
ClinicalTrials.gov Identifier:	NCT01507558 History of Changes
Other Study ID Numbers:	10-02101
First Posted:	January 11, 2012
Last Update Posted:	January 8, 2018
Last Verified:	January 2018

Keywords provided by Warren J. Gasper, MD, University of California, San Francisco:

Peripheral Arterial Disease; Femoral popliteal lesions

Additional relevant MeSH terms:

Peripheral Arterial Disease; Peripheral Vascular Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Dexamethasone acetate; Dexamethasone; 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