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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by Heart Centre Rotenburg.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
B. Braun Melsungen AG
Information provided by:
Heart Centre Rotenburg
ClinicalTrials.gov Identifier:
NCT01180517
First received: August 9, 2010
Last updated: October 1, 2012
Last verified: September 2012
  Purpose

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
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 Primary Completion Date: November 2012 (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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT01180517

Locations
Germany
Herzzentrum Dresden Not yet recruiting
Dresden, Germany, 01307
Contact: R. H. Strasser, MD,PhD    +49-351-450-1701    Ruth.Strasser@mailbox.tu-dresden.de   
Principal Investigator: R. H. Strasser, MD,PhD         
Klinikum Ernst von Bergmann Recruiting
Potsdam, Germany, 14467
Contact: F. X. Kleber, MD    +49-331-241-6102    fxkleber@linikumevb.de   
Principal Investigator: F. X. Kleber, MD         
Sponsors and Collaborators
Heart Centre Rotenburg
B. Braun Melsungen AG
Investigators
Principal Investigator: F. X. Kleber, MD Klinikum Ernst von Bergmann Potsdam, Germany
  More Information

No publications provided

Responsible Party: M. Boxberger, B.Braun Melsungen AG
ClinicalTrials.gov Identifier: NCT01180517     History of Changes
Other Study ID Numbers: AAG-G-H-1003
Study First Received: August 9, 2010
Last Updated: October 1, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Heart Centre Rotenburg:
Angioplasty Balloon

ClinicalTrials.gov processed this record on October 23, 2014