Angioplasty
Conditions
Keywords
Angioplasty Balloon
Brief 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.
Interventions
PROCEDUREPercutaneous coronary intervention (PCI)
balloon angioplasty
PROCEDUREPCI
balloon angioplasty
Sponsors
B. Braun Melsungen AG
Ralf Degenhardt, PhD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| In-segment late lumen loss in the side branch at 9 months | 9 months |
Countries
Germany
Outcome results
None listed