Evaluation of Paclitaxel in Patients With CLI and Femoropopliteal Occlusive Disease Treated With DCB Angioplasty

NACompletedINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

September 30, 2016

Primary Completion Date

December 31, 2022

Study Completion Date

December 31, 2022

Conditions
Ischemia
Interventions
DEVICE

Angiogram, Medtronic DCB (paclitaxel)/stent

Paclitaxel® coated balloons will be used for patients identified with Critical Limb Ischemia (CLI) and Tissue Loss. Each participant will receive angiogram with DCB (drug coated balloon)/stenting with wound debridement. 50% of subjects will receive an Angiogram, Medtronic DCB (paclitaxel)/stent. Tissue samples will be sent to pathology for specific staining to evaluate trace evidence of the drug paclitaxel.

DEVICE

Angiogram, Bard DCB (paclitaxel)/stent

Paclitaxel® coated balloons will be used for patients identified with Critical Limb Ischemia (CLI) and Tissue Loss. 50% of subjects will receive 'Angiogram, Bard DCB (paclitaxel)/stent' . Tissue samples will be sent to pathology for specific staining to evaluate trace evidence of the drug paclitaxel.

Trial Locations (1)

15237

Judith Brimmeier, Pittsburgh

All Listed Sponsors
lead

Rabih A. Chaer

OTHER

NCT02758847 - Evaluation of Paclitaxel in Patients With CLI and Femoropopliteal Occlusive Disease Treated With DCB Angioplasty | Biotech Hunter | Biotech Hunter