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The Paclitaxel-Eluting Percutaneous Coronary Angioplasty (PTCA)-Balloon Catheter for the Treatment of Coronary Bifurcations (PEPCAD-BIF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01180517
Recruitment Status : Completed
First Posted : August 12, 2010
Last Update Posted : February 19, 2016
B. Braun Melsungen AG
Information provided by (Responsible Party):
Ralf Degenhardt, PhD, Heart Centre Rotenburg

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 0,0,1 coronary bifurcation lesions. Patients will be randomized to treatment with Plain Old Balloon Angioplasty (POBA)or treatment with DEB.

Condition or disease Intervention/treatment Phase
Angioplasty Procedure: Percutaneous coronary intervention (PCI) Procedure: PCI Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Paclitaxel-Eluting PTCA-Balloon Catheter for the Treatment of Coronary Bifurcations
Study Start Date : November 2010
Actual Primary Completion Date : November 2014
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angioplasty

Arm Intervention/treatment
Active Comparator: Drug Eluting Balloon Procedure: Percutaneous coronary intervention (PCI)
balloon angioplasty

Active Comparator: Plain Old Balloon Angioplasty (POBA) Procedure: PCI
balloon angioplasty

Primary Outcome Measures :
  1. In-segment late lumen loss in the side branch at 9 months [ Time Frame: 9 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01180517

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Herzzentrum Dresden
Dresden, Germany, 01307
Klinikum Ernst von Bergmann
Potsdam, Germany, 14467
Sponsors and Collaborators
Ralf Degenhardt, PhD
B. Braun Melsungen AG
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Principal Investigator: F. X. Kleber, MD Klinikum Ernst von Bergmann Potsdam, Germany
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Responsible Party: Ralf Degenhardt, PhD, Data Manager, Heart Centre Rotenburg Identifier: NCT01180517    
Other Study ID Numbers: AAG-G-H-1003
First Posted: August 12, 2010    Key Record Dates
Last Update Posted: February 19, 2016
Last Verified: February 2016
Keywords provided by Ralf Degenhardt, PhD, Heart Centre Rotenburg:
Angioplasty Balloon