At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 643 enrolled
Drug / intervention
DEBlue stent vs. Cypher stentdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Paclitaxel-Eluting PTCA-Balloon in Combination With the CoroflexTM Blue Stent vs the Sirolimus Coated CypherTM Stent in the Treatment of Advanced Coronary Artery Disease
In Brief
A Phase 2 clinical trial evaluating DEBlue stent vs. Cypher stent for Coronary Artery Disease. Completed, enrolled 643 participants across 16 sites in 8 countries.
Detailed Summary
The aim of the study is to assess the safety and efficacy of the Paclitaxel-eluting SeQuent Please S stent system (DEBlue) in the treatment of stenoses in native coronary arteries with nominal stent diameters between ≥ 2.5 mm and ≤ 3.5 mm and \< 24 mm in length for procedural success and preservation of vessel patency in comparison to the Sirolimus-eluting CypherTM stent.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCoronary Artery Disease
CountriesBelgium, Czechia, France, Germany, Netherlands, Spain, Sweden, United Kingdom
CollaboratorsB.Braun Vascular Systems, Berlin, Germany
Timeline
Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 2007
Enrollment StartJul 2007
Primary CompletionOct 2008
Study CompletionJan 2011
TodayJul 2026
First PostedMay 15, 2007
Enrollment StartJul 1, 2007
Primary CompletionOct 1, 2008
Study CompletionJan 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 19.1 years ago
Interventions
DEBlue stent vs. Cypher stentdevice
DES vs. DEB with BMS