NCT01180517CompletedPhase 4
The Paclitaxel-Eluting PTCA-Balloon Catheter for the Treatment of Coronary Bifurcations
Ralf Degenhardt, PhD4 sites in 1 country64 target enrollmentStarted: November 1, 2010Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 64
- Locations
- 4
- Primary Endpoint
- In-segment late lumen loss in the side branch at 9 months
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
- •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
Outcomes
Primary Outcomes
In-segment late lumen loss in the side branch at 9 months
Time Frame: 9 months
Secondary Outcomes
No secondary outcomes reported
Investigators
Ralf Degenhardt, PhD
Data Manager
Heart Centre Rotenburg
Study Sites (4)
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