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

NCT01180517 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2016-02-19

No results posted yet for this study

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.

Conditions

  • Angioplasty

Interventions

PROCEDURE

Percutaneous coronary intervention (PCI)

balloon angioplasty

PROCEDURE

PCI

balloon angioplasty

Sponsors & Collaborators

  • B. Braun Melsungen AG

    collaborator INDUSTRY

  • Ralf Degenhardt, PhD

    lead OTHER

Principal Investigators

  • F. X. Kleber, MD · Klinikum Ernst von Bergmann Potsdam, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2014-11-30
Completion
2016-02-29

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01180517 on ClinicalTrials.gov