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

This study has been completed.
Sponsor:
Collaborator:
B. Braun Melsungen AG
Information provided by (Responsible Party):
Ralf Degenhardt, PhD, Heart Centre Rotenburg
ClinicalTrials.gov Identifier:
NCT01180517
First received: August 9, 2010
Last updated: February 18, 2016
Last verified: February 2016
  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 ]

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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Dresden, Germany, 01307
Klinikum Ernst von Bergmann
Potsdam, Germany, 14467
Sponsors and Collaborators
Ralf Degenhardt, PhD
B. Braun Melsungen AG
Investigators
Principal Investigator: F. X. Kleber, MD Klinikum Ernst von Bergmann Potsdam, Germany
  More Information

Responsible Party: Ralf Degenhardt, PhD, Data Manager, Heart Centre Rotenburg
ClinicalTrials.gov Identifier: NCT01180517     History of Changes
Other Study ID Numbers: AAG-G-H-1003 
Study First Received: August 9, 2010
Last Updated: February 18, 2016
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Heart Centre Rotenburg:
Angioplasty Balloon

Additional relevant MeSH terms:
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 27, 2016