Effectiveness of Adventitial Dexamethasone in Peripheral Artery Disease

Completed · Phase 4

Conditions studied: Peripheral Arterial Diseases

In brief

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.

Key facts

Study ID

NCT01983449

Run by

Mercator MedSystems, Inc.

People needed

285

Starts

2013-11-01

Expected to finish

2018-01-01

Last updated by the study team

2018-03-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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.)

Where it is running

• Arizona Heart Hospital / Abrazo Health Care Research / Tenet Health — Phoenix, Arizona, United States
• Pima Vascular — Tucson, Arizona, United States
• Arkansas Heart Hospital — Little Rock, Arkansas, United States
• Cardiovascular Medical Group of Southern California / Cardiovascular Research Foundation — Beverly Hills, California, United States
• St. Joseph Hospital of Orange Heart and Vascular Center — Orange, California, United States
• San Francisco VA Medical Center — San Francisco, California, United States
• University of California San Francisco Medical Center — San Francisco, California, United States
• VA Eastern Colorado Healthcare System — Denver, Colorado, United States
• Hartford Hospital — Hartford, Connecticut, United States
• MedStar Health Washington Hospital Center — Washington D.C., District of Columbia, United States
• First Coast Cardiovascular Institute — Jacksonville, Florida, United States
• Munroe Regional Medical Center — Ocala, Florida, United States
• Coastal Vascular & Interventional — Pensacola, Florida, United States
• St. Joseph Hospital — Fort Wayne, Indiana, United States
• Willis-Knighton Medical Center — Shreveport, Louisiana, United States
• UMass Medical School — Worcester, Massachusetts, United States
• St. John Providence Hospital and Medical Center — Detroit, Michigan, United States
• Hattiesburg Clinic — Hattiesburg, Mississippi, United States
• University of Mississippi Medical Center — Jackson, Mississippi, United States
• St.Louis University Hospital — St Louis, Missouri, United States
• Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States
• Deborah Heart & Lung Center — Browns Mills, New Jersey, United States
• Hunterdon Medical Center — Flemington, New Jersey, United States
• Rutgers New Jersey Medical School — Newark, New Jersey, United States
• Albany Vascular Group — Albany, New York, United States

Full record on ClinicalTrials.gov

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