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Paclitaxel-Eluting Balloon Angioplasty and Coroflex™-Stents in the Treatment of Bifurcated Coronary Lesions

NCT00540813 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2017-02-23

No results posted yet for this study

Summary

The aim of the study is to investigate the feasibility of Paclitaxel-eluting PTCA-balloon dilation (SeQuent Please) followed by bare metal stent (Coroflex ) deployment in the main branch (reference diameter: ≥ 2.5 mm and ≤ 3.8 mm, reference diameter of side branch: ≥ 2.0 mm and ≤ 3.5 mm, length of stenoses in either branch ≤ 20 mm) in the treatment of significant (\>70%) de-novo-bifurcation stenoses of any Medina classification type in the native left coronary artery as reflected by procedural success and to evaluate the preservation of vessel patency.

Conditions

  • Ischemia
  • Stenosis

Interventions

DEVICE

drug eluting balloon

drug eluting balloon bifurcated coronary lesions single arm study

Sponsors & Collaborators

  • B. Braun Melsungen AG

    collaborator INDUSTRY

  • Clinical Research Institute Rotenburg a.d.F.

    collaborator UNKNOWN

  • Heart Centre Rotenburg

    lead OTHER

Principal Investigators

  • D. G. Mathey, MD · Hamburg University Cardiovascular Center GmbH

  • F. X. Kleber, MD · Department of Internal Medicine Unfallkrankenhaus Berlin

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2011-05-31
Completion
2016-10-31

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 NCT00540813 on ClinicalTrials.gov