Status:
COMPLETED
The Paclitaxel-Eluting Percutaneous Coronary Angioplasty (PTCA)-Balloon Catheter for the Treatment of Coronary Bifurcations
Lead Sponsor:
Ralf Degenhardt, PhD
Collaborating Sponsors:
B. Braun Melsungen AG
Conditions:
Angioplasty
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The intention of this trial is to assess the safety and efficacy of Drug Eluting Balloon (DEB) application (SeQuent Please) to the side branch in percutaneous coronary intervention (PCI) of Medina 0,0...
Eligibility Criteria
Inclusion
- Inclusion Criteria (main):
- De-novo Medina type 0,0,1 bifurcational native coronary artery lesion (reference diameter:\>2.0 mm \<3.5 mm, length of stenosis: ≤ 10 mm), the diameter of the side branch shall be smaller or equal to the diameter of the distal end vessel
- Exclusion Criteria (main):
- Reference side branch diameter \> 3.5 mm
- Evidence of extensive thrombosis within target vessel
- Patients with another coronary stent implanted previously into the target branch or bifurcation ≤ 15 mm distant to the current lesion, drug eluting stents less than 9 months and bare metal stents or stents with passive coatings less than 3 months before the PEPCAD- BIF
Exclusion
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2016
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT01180517
Start Date
November 1 2010
End Date
February 1 2016
Last Update
February 19 2016
Active Locations (2)
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1
Herzzentrum Dresden
Dresden, Germany, 01307
2
Klinikum Ernst von Bergmann
Potsdam, Germany, 14467