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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
B. Braun Melsungen AG
OrbusNeich
Information provided by:
University of Ulm
ClinicalTrials.gov Identifier:
NCT00732953
First received: August 7, 2008
Last updated: August 23, 2010
Last verified: March 2009
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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:

Drug Information available for: Paclitaxel
U.S. FDA Resources

Further study details as provided by University of Ulm:

Primary Outcome Measures:
  • Late loss [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Diameter stenosis [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Binary restenosis rate [ Time Frame: 6 month ] [ Designated as safety issue: No ]
  • Late loss index [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Target lesion revascularization [ Time Frame: 2, 6, 12, 24, 36, 48, 60 months ] [ Designated as safety issue: No ]
  • Target vessel revascularization [ Time Frame: 2, 6, 12, 24, 36, 48, 60 months ] [ Designated as safety issue: No ]
  • Major adverse cardiac events [ Time Frame: 2, 6, 12, 24, 36, 48, 60 months ] [ Designated as safety issue: Yes ]
  • Stent thrombosis [ Time Frame: 2, 6, 12, 24, 36, 48, 60 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 120
Study Start Date: February 2009
Estimated Study Completion Date: February 2014
Estimated 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by University of Ulm

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Prof. Dr. Jochen Wöhrle, University of Ulm
ClinicalTrials.gov Identifier: NCT00732953     History of Changes
Other Study ID Numbers: UULM-JW-GP
Study First Received: August 7, 2008
Last Updated: August 23, 2010
Health Authority: Germany: Ethics Commission

Keywords provided by 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
 Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 13, 2013