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DEBlue Stent vs Cypher Stent in the Treatment of Advanced Coronary Artery Disease

NCT00473772 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 643

Last updated 2014-05-06

No results posted yet for this study

Summary

The aim of the study is to assess the safety and efficacy of the Paclitaxel-eluting SeQuent Please S stent system (DEBlue) in the treatment of stenoses in native coronary arteries with nominal stent diameters between ≥ 2.5 mm and ≤ 3.5 mm and \< 24 mm in length for procedural success and preservation of vessel patency in comparison to the Sirolimus-eluting CypherTM stent.

Conditions

Interventions

DEVICE

DEBlue stent vs. Cypher stent

DES vs. DEB with BMS

Sponsors & Collaborators

  • B.Braun Vascular Systems, Berlin, Germany

    collaborator UNKNOWN

  • University Hospital, Saarland

    lead OTHER

Principal Investigators

  • Bruno Scheller · University of Saarland - Internal Medicine III, Homburg/Saar, Germany

  • Christian Hamm · Kerckhoff-Clinic Bad Nauheim, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2008-10-31
Completion
2011-01-31

Countries

  • Belgium
  • Czechia
  • France
  • Germany
  • Netherlands
  • Spain
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

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 NCT00473772 on ClinicalTrials.gov