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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2015 by Heart Centre Rotenburg
B. Braun Melsungen AG
Information provided by (Responsible Party):
Ralf Degenhardt, PhD, Heart Centre Rotenburg Identifier:
First received: August 9, 2010
Last updated: March 17, 2015
Last verified: March 2015
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
Procedure: Percutaneous coronary intervention (PCI)
Procedure: PCI
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Heart Centre Rotenburg:

Primary Outcome Measures:
  • In-segment late lumen loss in the side branch at 9 months [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: November 2010
Estimated Study Completion Date: September 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
Genders Eligible for Study:   Both
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 Not yet recruiting
Dresden, Germany, 01307
Contact: R. H. Strasser, MD,PhD    +49-351-450-1701   
Principal Investigator: R. H. Strasser, MD,PhD         
Klinikum Ernst von Bergmann Recruiting
Potsdam, Germany, 14467
Contact: F. X. Kleber, MD    +49-331-241-6102   
Principal Investigator: F. X. Kleber, MD         
Sponsors and Collaborators
Ralf Degenhardt, PhD
B. Braun Melsungen AG
Principal Investigator: F. X. Kleber, MD Klinikum Ernst von Bergmann Potsdam, Germany
  More Information

No publications provided

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: March 17, 2015
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Heart Centre Rotenburg:
Angioplasty Balloon processed this record on February 11, 2016