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

NCT ID: NCT01180517

Last Updated: 2016-02-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2016-02-29

Brief Summary

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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.

Detailed Description

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Conditions

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Angioplasty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Drug Eluting Balloon

Group Type ACTIVE_COMPARATOR

Percutaneous coronary intervention (PCI)

Intervention Type PROCEDURE

balloon angioplasty

Plain Old Balloon Angioplasty (POBA)

Group Type ACTIVE_COMPARATOR

PCI

Intervention Type PROCEDURE

balloon angioplasty

Interventions

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Percutaneous coronary intervention (PCI)

balloon angioplasty

Intervention Type PROCEDURE

PCI

balloon angioplasty

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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B. Braun Melsungen AG

INDUSTRY

Sponsor Role collaborator

Ralf Degenhardt, PhD

OTHER

Sponsor Role lead

Responsible Party

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Ralf Degenhardt, PhD

Data Manager

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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F. X. Kleber, MD

Role: PRINCIPAL_INVESTIGATOR

Klinikum Ernst von Bergmann Potsdam, Germany

Locations

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Herzzentrum Dresden

Dresden, , Germany

Site Status

Klinikum Ernst von Bergmann

Potsdam, , Germany

Site Status

Countries

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Germany

Other Identifiers

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AAG-G-H-1003

Identifier Type: -

Identifier Source: org_study_id

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