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

This study has been completed.
B. Braun Melsungen AG
Information provided by (Responsible Party):
Ralf Degenhardt, PhD, Heart Centre Rotenburg Identifier:
First received: August 9, 2010
Last updated: February 18, 2016
Last verified: February 2016
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 Intervention Phase
Angioplasty Procedure: Percutaneous coronary intervention (PCI) Procedure: PCI Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Ralf Degenhardt, PhD, Heart Centre Rotenburg:

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

Enrollment: 64
Study Start Date: November 2010
Study Completion Date: February 2016
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Drug Eluting Balloon Procedure: Percutaneous coronary intervention (PCI)
balloon angioplasty
Active Comparator: Plain Old Balloon Angioplasty (POBA) Procedure: PCI
balloon angioplasty


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01180517

Herzzentrum Dresden
Dresden, Germany, 01307
Klinikum Ernst von Bergmann
Potsdam, Germany, 14467
Sponsors and Collaborators
Ralf Degenhardt, PhD
B. Braun Melsungen AG
Principal Investigator: F. X. Kleber, MD Klinikum Ernst von Bergmann Potsdam, Germany
  More Information

Responsible Party: Ralf Degenhardt, PhD, Data Manager, Heart Centre Rotenburg Identifier: NCT01180517     History of Changes
Other Study ID Numbers: AAG-G-H-1003
Study First Received: August 9, 2010
Last Updated: February 18, 2016

Keywords provided by Ralf Degenhardt, PhD, Heart Centre Rotenburg:
Angioplasty Balloon

Additional relevant MeSH terms:
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action processed this record on August 21, 2017