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

Ralf Degenhardt, PhD

Status and phase

Completed

Phase 4

Conditions

Angioplasty

Treatments

Procedure: PCI

Procedure: Percutaneous coronary intervention (PCI)

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01180517

AAG-G-H-1003

Details and patient eligibility

About

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.

Enrollment

64 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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