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Sponsored by: |
University Hospital, Saarland |
Information provided by: | University Hospital, Saarland |
ClinicalTrials.gov Identifier: | NCT00106587 |
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.
Condition | Intervention | Phase |
Coronary Restenosis |
Device: paclitaxel coated balloon catheter (device with drug) |
Phase I Phase II |
ChemIDplus related topics: | Paclitaxel |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Treatment of in-Stent Restenosis by Paclitaxel Coated PTCA Balloons |
Estimated Enrollment: | 52 |
Study Start Date: | December 2003 |
Estimated Study Completion Date: | March 2005 |
Background: Drug-eluting stents have shown promising anti-restenotic effects in clinical trials. It may be preferable, however, to avoid the stent-in-stent approach in treating in-stent restenosis (ISR). In prior animal trials, we demonstrated a highly significant reduction of neointimal formation by drug-eluting balloon catheters (DEB). The aim of the PACCOCATH ISR study is to investigate the novel DEB in the treatment of ISR.
Methods and results: The PACCOCATH ISR study is a randomized, double-blind German multicenter trial on the efficacy and tolerance of the DEB in coronary ISR. Patients are randomized to rePTCA of ISR either using the coated PTCA balloon (3 µg paclitaxel/mm² balloon surface) or a non-coated balloon of the same type (n=52 patients). Balloon inflation time is 60 seconds in both cases. Major inclusion criteria are an ISR in a coronary artery with a diameter stenosis of at least 70%, < 25 mm length, and a vessel diameter of 2.5 to 3.5 mm. The primary endpoint is late lumen loss after 6 months (independent angiographic core lab). Secondary endpoints are binary restenosis rate and major adverse cardiac events.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Germany | |||||
Medizinische Universitätsklinik III, Abt. Kardiologie und Angiologie | |||||
Freiburg, Germany, 79106 | |||||
Kardiologie, Campus Virchow-Klinikum, Charite | |||||
Berlin, Germany, 13353 | |||||
Kardiologie, Campus Mitte, Charite | |||||
Berlin, Germany, 10117 | |||||
I. Medizinische Klinik, Universitaetsklinikum | |||||
Mannheim, Germany, 68167 | |||||
Germany, Saarland | |||||
Klinik fuer Innere Medizin III, Universitaetsklinikum des Saarlandes | |||||
HOMBURG / SAAR, Saarland, Germany, 66421 |
University Hospital, Saarland |
Principal Investigator: | Bruno Scheller, MD | Klinik fuer Innere Medizin III, Universitaetsklinikum des Saarlandes, 66421 Homburg/Saar, Germany |
Study Director: | Ulrich Speck, PhD | Radiologie, Campus Mitte, Charite, Berlin, Germany |
Study ID Numbers: | BMT – Pac 1 |
First Received: | March 25, 2005 |
Last Updated: | November 9, 2005 |
ClinicalTrials.gov Identifier: | NCT00106587 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
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