Prevention of Restenosis After Genous Stent Implantation Using a Paclitaxel Eluting Balloon in Coronary Arteries

June 7, 2014 updated by: Jochen Wohrle, University of Ulm

Prevention of Restenosis After Genous Stent Implantation Using a Paclitaxel Eluting Balloon in Coronary Arteries - a Randomized Clinical Trial.

Percutaneous coronary intervention with stent implantation is limited on the one hand by restenosis due to smooth muscle cell proliferation and on the other hand by stent thrombosis due to incomplete or not sufficient enough endothelialization of stent struts. The Genous stent implantation allows a rapid layer over the stent struts with endothelial progenitor cells allowing a fast endothelialization and probably reducing the risk of stent thrombosis. Local therapy with drug-eluting balloons administering paclitaxel has been shown to reduce restenosis in in-stent restenosis and de-novo lesions in vessels with small reference diameter. The combination of a paclitaxel-eluting balloon and Genous stent implantation may summarized both advantages: a rapid endothelialization limiting the number of stent thrombosis and on the other hand a reduction of smooth muscle cell proliferation minimizing the risk of restenosis with the subsequent need for revascularization.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Coburg, Germany, 96450
        • Klinikum Coburg
      • Ulm, Germany, 89081
        • University of Ulm
      • Villingen-Schwenningen, Germany, 78011
        • Schwarzwald-Baar Klinikum

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients >18 years old
  • lesion in native coronary artery
  • de-novo stenosis
  • indication for revascularization (angina status, myocardial ischemia, positive stress test, pathologic FFR)
  • range of reference diameter 2.5 to 4.0mm

Exclusion Criteria:

  • lesion in saphenous vein graft
  • chronic total occlusion
  • bifurcation lesion requiring stenting of main and side branch
  • left main stenosis
  • restenosis
  • in-Stent restenosis
  • contraindication for dual antiplatelet therapy for the following 6 months
  • coronary aneurysm in target vessel

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 1
Genous stent implantation with paclitaxel-eluting balloon therapy
Device: Genous stent implantation with paclitaxel-eluting balloon dilation
Genous stent implantation with paclitaxel-eluting balloon therapy
ACTIVE_COMPARATOR: 2
Genous stent implantation
Device: Genous stent implantation
Genous stent implantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Late loss
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Diameter stenosis
Time Frame: 6 months
6 months
Binary restenosis rate
Time Frame: 6 month
6 month
Late loss index
Time Frame: 6 months
6 months
Target lesion revascularization
Time Frame: 2, 6, 12, 24, 36, 48, 60 months
2, 6, 12, 24, 36, 48, 60 months
Target vessel revascularization
Time Frame: 2, 6, 12, 24, 36, 48, 60 months
2, 6, 12, 24, 36, 48, 60 months
Major adverse cardiac events
Time Frame: 2, 6, 12, 24, 36, 48, 60 months
2, 6, 12, 24, 36, 48, 60 months
Stent thrombosis
Time Frame: 2, 6, 12, 24, 36, 48, 60 months
2, 6, 12, 24, 36, 48, 60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Ulm

Collaborators

B. Braun Melsungen AG
OrbusNeich

Investigators

  • Principal Investigator: Jochen Wöhrle, MD, University of Ulm

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (ACTUAL)

January 1, 2010

Study Completion (ACTUAL)

February 1, 2014

Study Registration Dates

First Submitted

August 7, 2008

First Submitted That Met QC Criteria

August 8, 2008

First Posted (ESTIMATE)

August 12, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

June 10, 2014

Last Update Submitted That Met QC Criteria

June 7, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UULM-JW-GP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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