Effectiveness of Adventitial Dexamethasone in Peripheral Artery Disease



Status:Completed
Conditions:Peripheral Vascular Disease
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:4/17/2018
Start Date:November 2013
End Date:January 2018

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Delivery of Dexamethasone to the Adventitia to eNhance Clinical Efficacy After Femoropopliteal Revascularization

To assess the safety and effectiveness of adventitial deposition of the Study Drug in
reducing inflammation and restenosis in patients with clinical evidence of claudication or
critical limb ischemia and an angiographically significant lesion in the superficial femoral
and/or popliteal arteries.

Study Drug and Dose: Dexamethasone Sodium Phosphate Injection, USP, 4 mg/ml, with dilute
contrast (17%) administered to the adventitia in a dose of 1.6 mg per cm of desired vessel
treatment length.

This trial will examine the ability for adventitial dexamethasone to safely delay restenosis
in patients at least 18 years of age, who have peripheral atherosclerotic lesions involving
the superficial femoral and/or popliteal arteries. These patients have no current therapeutic
alternatives beyond the procedure used to open, or revascularize, their superficial femoral
and/or popliteal arteries. Metal stents have the potential to fracture when implanted in this
artery segment due to continual flexion and bending of the knee. It is desirable to improve
the patency of this artery after percutaneous transluminal angioplasty (PTA) and/or
atherectomy-based revascularization.

Inclusion Criteria:

- Screening Criteria

- Male or non-pregnant female ≥18 years of age

- Rutherford Clinical Category 2-4

- Clinical diagnosis of PAD requiring revascularization, secondary to
atherosclerosis affecting a lower limb

- Patient is willing to provide informed consent and comply with the required
follow up visits, testing schedule, and medication regimen

- Procedural Criteria

- De novo or nonstented restenotic lesions >90 days from prior angioplasty and/or
atherectomy, at least 3 cm from any previously placed stent or vascular surgery
site

- >70% diameter stenosis up to 15 cm in total length (with no greater than 3 cm
length of contiguous intervening normal artery) in the superficial femoral and/or
popliteal artery (between the profunda and tibioperoneal trunk)

- Reference vessel diameter ≥3mm and ≤ 8mm

- Successful wire crossing of lesion

- A patent artery proximal to the index lesion free from significant stenosis
(significant stenosis is defined as >50% in iliac or >30% stenosis in common
femoral artery) as confirmed by angiography (treatment of target lesion after
successful treatment of iliac or common femoral artery lesions is acceptable)

Exclusion Criteria:

- Screening Criteria

- Pregnant, nursing or planning on becoming pregnant in < 2 years

- Life expectancy of <2 years

- Known active malignancy

- History of solid organ transplantation

- Patient actively participating in another investigational device or drug study

- History of hemorrhagic stroke within 3 months

- Previous or planned surgical or interventional procedure within 30 days of index
procedure

- Chronic renal insufficiency with eGFR <29

- Prior bypass surgery, stenting of the target lesion

- Inability to take required study medications

- Contra-indication or known hypersensitivity to dexamethasone sodium phosphate,
contrast media, or Physician prescribed antiplatelet regimen as indicated

- Systemic fungal infection

- Anticipated use of IIb/IIIa inhibitor prior to index lesion treatment

- Acute or sub-acute thrombus, acute vessel occlusion or sudden symptom onset

- Acute limb ischemia

- Prior participation of the index limb in the current study (contralateral
treatment is allowed)

- Inability to ambulate (e.g. from prior ipsilateral or contralateral amputation)

- Patient is receiving steroids already, however locally acting inhaled steroids
for asthma treatment do not exclude patients from the trial

- Procedural Criteria

- Lesions extending into the trifurcation or above the profunda

- Heavy eccentric or moderate circumferential calcification at index lesion, which
in the judgment of the investigator would prevent penetration of the
Micro-Infusion Catheter needle through the vessel wall

- Lesion length is >15 cm as measured from proximal normal vessel to distal normal
vessel, or there is no normal proximal arterial segment in which duplex
ultrasound velocity ratios can be measured

- Inadequate distal outflow defined as absence of at least one patent tibial artery
(no lesion >50% stenosis) with flow into the foot

- Use of adjunctive therapies other than angioplasty, atherectomy (mechanical or
laser) or bare metal stenting (i.e. scoring/cutting balloon, drug-eluting stent,
drug-coated balloon, cryoplasty, etc.)
We found this trial at
38
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Jacksonville, Florida 32216
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2500 N State St
Jackson, Mississippi 39216
(601) 984-1000
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Ocala, Florida 34471
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Albany, New York 12208
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Browns Mills, New Jersey 08015
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180 East Broad Street
Columbus, Ohio 43214
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Dallas, Texas 75208
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Denver, Colorado 80220
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Flemington, New Jersey 08822
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Fort Wayne, Indiana 46802
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Fort Worth, Texas 76104
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80 Seymour St
Hartford, Connecticut 6102
(860) 545-5000
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Hattiesburg, Mississippi 39401
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Kingsport, Tennessee 37660
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1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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Little Rock, Arkansas 72211
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630 W 168th St
New York, New York
212-305-2862
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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Newark, New Jersey 07103
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Palestine, Texas 75801
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Pensacola, Florida 32204
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Pittsburgh, Pennsylvania 15232
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164 Summit Ave
Providence, Rhode Island 02906
(401) 793-2500
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Raleigh, North Carolina 27607
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3635 Vista Avenue
Saint Louis, Missouri 63110
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Salt Lake City, Utah 84041
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San Francisco, California 94121
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505 Parnassus Ave
San Francisco, California 94143
(415) 476-1000
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Seattle, Washington 98195
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Shreveport, Louisiana 71103
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Tucson, Arizona 85718
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Washington, District of Columbia 20010
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Worcester, Massachusetts 01655
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