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

Ralf Degenhardt, PhD64 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Angioplasty

Interventions

Percutaneous coronary intervention (PCI)PROCEDURE

balloon angioplasty

PCIPROCEDURE

balloon angioplasty

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Herzzentrum Dresden

Dresden, Germany

Klinikum Ernst von Bergmann

Potsdam, Germany

Outcomes

Primary Outcomes

In-segment late lumen loss in the side branch at 9 months

Time frame: 9 months

Data from ClinicalTrials.gov

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