Treatment of In-Stent Restenosis by Paclitaxel Coated PTCA Balloons (PACCOCATH - ISR I)
NCT00106587 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 52
Last updated 2023-04-27
Summary
The PACCOCATH ISR study is a randomized, double-blinded German multicenter trial on the efficacy and tolerance of a paclitaxel coated balloon catheter in coronary in-stent restenosis.
Conditions
- Coronary Restenosis
Interventions
- DEVICE
-
PTCA
- COMBINATION_PRODUCT
-
paclitaxel coated balloon catheter (device with drug)
Sponsors & Collaborators
-
University Hospital, Saarland
lead OTHER
Principal Investigators
-
Bruno Scheller, MD · Klinik fuer Innere Medizin III, Universitaetsklinikum des Saarlandes, 66421 Homburg/Saar, Germany
-
Ulrich Speck, PhD · Radiologie, Campus Mitte, Charite, Berlin, Germany
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2003-12-31
- Primary Completion
- 2006-11-30
- Completion
- 2012-03-31
Countries
- Germany
Study Locations
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