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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00732953
First Posted: August 12, 2008
Last Update Posted: June 10, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
B. Braun Melsungen AG
OrbusNeich
Information provided by (Responsible Party):
Jochen Wohrle, University of Ulm
  Purpose
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.

Condition Intervention Phase
Coronary Artery Disease Device: Genous stent implantation with paclitaxel-eluting balloon dilation Device: Genous stent implantation Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Prevention of Restenosis After Genous Stent Implantation Using a Paclitaxel Eluting Balloon in Coronary Arteries - a Randomized Clinical Trial.

Resource links provided by NLM:


Further study details as provided by Jochen Wohrle, University of Ulm:

Primary Outcome Measures:
  • Late loss [ Time Frame: 6 months ]

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

Enrollment: 120
Study Start Date: February 2009
Study Completion Date: February 2014
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00732953


Locations
Germany
Klinikum Coburg
Coburg, Germany, 96450
University of Ulm
Ulm, Germany, 89081
Schwarzwald-Baar Klinikum
Villingen-Schwenningen, Germany, 78011
Sponsors and Collaborators
University of Ulm
B. Braun Melsungen AG
OrbusNeich
Investigators
Principal Investigator: Jochen Wöhrle, MD University of Ulm
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jochen Wohrle, Prof. Dr. Jochen Wöhrle, University of Ulm
ClinicalTrials.gov Identifier: NCT00732953     History of Changes
Other Study ID Numbers: UULM-JW-GP
First Submitted: August 7, 2008
First Posted: August 12, 2008
Last Update Posted: June 10, 2014
Last Verified: June 2014

Keywords provided by Jochen Wohrle, University of Ulm:
patients with coronary artery disease
percutaneous coronary intervention
stent implantation
paclitaxel eluting balloon
angiographic follow-up
clinical follow-up

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action