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

This study has been completed.
Sponsor:
Collaborators:
B. Braun Melsungen AG
OrbusNeich
Information provided by (Responsible Party):
Jochen Wohrle, University of Ulm
ClinicalTrials.gov Identifier:
NCT00732953
First received: August 7, 2008
Last updated: June 7, 2014
Last verified: June 2014
  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:


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 ]

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Publications:
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
Study First Received: August 7, 2008
Last Updated: June 7, 2014
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
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 19, 2014