Lower-Limb Adventitial Infusion of DexaMethasone Via Bullfrog to Reduce Occurrence of Restenosis After Percutaneous Transluminal Angioplasty Revascularization

PHASE2UnknownINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

January 31, 2016

Primary Completion Date

August 31, 2020

Study Completion Date

August 31, 2020

Conditions
Chronic Limb Ischemia
Interventions
DRUG

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."

Trial Locations (3)

79189

RECRUITING

Universitäts-Herzzentrum Freiburg Bad Krozingen GmbH, Bad Krozingen

96515

RECRUITING

Medinos Kliniken des Landkreiss Sonneberg GmbH, Sonneberg

04103

RECRUITING

Universitätsklinikum Leipzig AöR, Leipzig

Sponsors
All Listed Sponsors
lead

Mercator MedSystems, Inc.

INDUSTRY

NCT02479555 - Lower-Limb Adventitial Infusion of DexaMethasone Via Bullfrog to Reduce Occurrence of Restenosis After Percutaneous Transluminal Angioplasty Revascularization | Biotech Hunter | Biotech Hunter