NCT01495533View on ClinicalTrials.gov

Paclitaxel-coated or Uncoated AngioSculpt Scoring Balloon Catheter

PHASE3CompletedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

December 31, 2011

Primary Completion Date

December 31, 2013

Study Completion Date

July 31, 2014

Conditions
In-stent Arterial Restenosis
Interventions
DEVICE

uncoated AngioSculpt(R)

Predilatation of coronary BMS-ISR with POBA followed by a AngioSculpt(R) scoring balloon (no drug coating)

COMBINATION_PRODUCT

Drug coated AngioSculpt(R)

Predilatation of coronary BMS-ISR with POBA followed by a drug coated AngioSculpt(R) scoring balloon (paclitaxel 3.0 µg/mm²)

Trial Locations (3)

66421

Internal Medicine III, UKS, Homburg Saar

Unknown

Danta Pazzanese Heart Institute, São Paulo

Herzzentrum Leipzig, Leipzig

All Listed Sponsors
lead

University Hospital, Saarland

OTHER

NCT01495533 - Paclitaxel-coated or Uncoated AngioSculpt Scoring Balloon Catheter | Biotech Hunter | Biotech Hunter