Lower-Limb Adventitial Infusion of DexaMethasone Via Bullfrog to Reduce Occurrence of Restenosis After Atherectomy (ATX)-Based Revascularization

PHASE2UnknownINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

June 30, 2016

Primary Completion Date

November 30, 2019

Study Completion Date

March 31, 2020

Conditions
Chronic Limb Ischemia
Interventions
DRUG

Dexamethasone Sodium Phosphate Injection, USP, 4 mg/mL

Following atherecomy-based revascularization, Investigators will be unblinded to assignment and will treat only patients assigned to the treatment arm with the Bullfrog delivery of dexamethasone.

Trial Locations (10)

27607

UNC Health Care - Rex Hospital, Raleigh

37934

Tennova - Turkey Creek Medical Center, Knoxville

39401

Hattiesburg Clinic, Hattiesburg

48604

Mid-Michigan Heart & Vascular, Saginaw

57101

Sanford Research, Sioux Falls

63110

St.Louis University Hospital, St Louis

72211

Arkansas Heart Hospital, Little Rock

78130

Mission Research Institute (New Braunfels Cardiology - GRMC), New Braunfels

80220

Denver Veterans Administration Hospital, Denver

07666

Holy Name Medical Center, Teaneck

Sponsors
All Listed Sponsors
lead

Mercator MedSystems, Inc.

INDUSTRY

NCT02479620 - Lower-Limb Adventitial Infusion of DexaMethasone Via Bullfrog to Reduce Occurrence of Restenosis After Atherectomy (ATX)-Based Revascularization | Biotech Hunter | Biotech Hunter