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Completed

NCT Number: NCT01180517

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

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.

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Key information

Conditions

Angioplasty

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Herzzentrum Dresden, Dresden, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Percutaneous Coronary Intervention (PCI)

Procedure

balloon angioplasty

PCI

Procedure

balloon angioplasty

Primary outcomes

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

    Time frame: 9 months

Sponsors and collaborators

Lead sponsor

Ralf Degenhardt, PhD

Other

Collaborators

  • B. Braun Melsungen AG

Registry information

Official study title

The Paclitaxel-Eluting PTCA-Balloon Catheter for the Treatment of Coronary Bifurcations

Acronym: PEPCAD-BIF

Important dates

Study start
2010
Primary completion
2014
Study completion
2016
First posted
Aug 12, 2010
Registry last updated
Feb 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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