120
Participants
Start Date
January 31, 2016
Primary Completion Date
August 31, 2020
Study Completion Date
August 31, 2020
Dexamethasone sodium phosphate injection, USP, 4 mg/mL
"Post-balloon angioplasty revascularization, the unblinded Pharmacist will prepare a sterile 20 mL syringe (Luer locking) with 16 mL of investigational drug or placebo per assignment. The unblinded Pharmacist provides syringe to investigator. Syringe shall only be labeled with the study number, patient number, randomization number and Investigational Drug.~Investigational Drug will be administered via Bullfrog Micro-Infusion Device."
RECRUITING
Universitäts-Herzzentrum Freiburg Bad Krozingen GmbH, Bad Krozingen
RECRUITING
Medinos Kliniken des Landkreiss Sonneberg GmbH, Sonneberg
RECRUITING
Universitätsklinikum Leipzig AöR, Leipzig
Lead Sponsor
Mercator MedSystems, Inc.
INDUSTRY