- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01180517
The Paclitaxel-Eluting Percutaneous Coronary Angioplasty (PTCA)-Balloon Catheter for the Treatment of Coronary Bifurcations (PEPCAD-BIF)
February 18, 2016 updated by: Ralf Degenhardt, PhD
The Paclitaxel-Eluting PTCA-Balloon Catheter for the Treatment of Coronary Bifurcations
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
64
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Dresden, Germany, 01307
- Herzzentrum Dresden
-
Potsdam, Germany, 14467
- Klinikum Ernst von Bergmann
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Drug Eluting Balloon
|
balloon angioplasty
|
Active Comparator: Plain Old Balloon Angioplasty (POBA)
|
balloon angioplasty
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
In-segment late lumen loss in the side branch at 9 months
Time Frame: 9 months
|
9 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: F. X. Kleber, MD, Klinikum Ernst von Bergmann Potsdam, Germany
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2010
Primary Completion (Actual)
November 1, 2014
Study Completion (Actual)
February 1, 2016
Study Registration Dates
First Submitted
August 9, 2010
First Submitted That Met QC Criteria
August 11, 2010
First Posted (Estimate)
August 12, 2010
Study Record Updates
Last Update Posted (Estimate)
February 19, 2016
Last Update Submitted That Met QC Criteria
February 18, 2016
Last Verified
February 1, 2016
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- AAG-G-H-1003
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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