The Paclitaxel-Eluting Percutaneous Transluminal Coronary Angioplasty (PTCA) - Balloon Catheter in Coronary Artery Disease to Treat Chronic Total Occlusions

NCT00670436 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2014-06-10

No results posted yet for this study

Summary

The aim of the study is to assess the safety and efficacy of a Paclitaxel-eluting PTCA-balloon in combination with bare-metal stenting for treatment of chronic total occlusions in native coronary arteries with reference diameters between 2.5 mm and 4.0 mm.

Conditions

Interventions

DEVICE

paclitaxel eluting PTCA balloon catheter (SeQuent Please)

paclitaxel eluting PTCA balloon catheter after bare-metal stenting of chronic total occlusion in a native coronary artery

DEVICE

paclitaxel eluting Taxus stent (Boston Scientific)

paclitaxel-eluting Taxus stents (Boston Scientific) in chronic total occlusion in native coronary arteries

Sponsors & Collaborators

  • B. Braun Melsungen AG

    collaborator INDUSTRY
  • University of Ulm

    lead OTHER

Principal Investigators

  • Jochen Wöhrle, MD; FESC · University of Ulm, Ulm, Germany

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2009-09-30
Completion
2014-03-31

Countries

  • Germany

Study Locations

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Entities

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 NCT00670436 on ClinicalTrials.gov