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NCT01180517 Clinical Trial

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

Angioplasty Clinical Trial

— PEPCAD-BIF  

Official title:
The Paclitaxel-Eluting PTCA-Balloon Catheter for the Treatment of Coronary Bifurcations

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01180517
Other study ID # AAG-G-H-1003
Secondary ID
Status Completed
Phase Phase 4
First received August 9, 2010
Last updated February 18, 2016
Start date November 2010
Est. completion date February 2016

Study information
Verified date February 2016
Source Heart Centre Rotenburg
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 64
Est. completion date February 2016
Est. primary completion date November 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Percutaneous coronary intervention (PCI)
balloon angioplasty
• PCI
balloon angioplasty

Locations
Country Name City State
Germany Herzzentrum Dresden Dresden
Germany Klinikum Ernst von Bergmann Potsdam

Sponsors (2)
Lead Sponsor Collaborator
Ralf Degenhardt, PhD B. Braun Melsungen AG

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary In-segment late lumen loss in the side branch at 9 months 9 months No
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