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OpenTrials
Completed

NCT Number: NCT00732953

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

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Klinikum Coburg, Coburg, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Genous stent implantation with paclitaxel-eluting balloon dilation

Device

Genous stent implantation with paclitaxel-eluting balloon therapy

Genous stent implantation

Device

Genous stent implantation

Primary outcomes

  1. Late loss

    Time frame: 6 months

Secondary outcomes

  1. Diameter stenosis

    Time frame: 6 months

  2. Binary restenosis rate

    Time frame: 6 month

  3. Late loss index

    Time frame: 6 months

  4. Target lesion revascularization

    Time frame: 2, 6, 12, 24, 36, 48, 60 months

  5. Target vessel revascularization

    Time frame: 2, 6, 12, 24, 36, 48, 60 months

  6. Major adverse cardiac events

    Time frame: 2, 6, 12, 24, 36, 48, 60 months

  7. Stent thrombosis

    Time frame: 2, 6, 12, 24, 36, 48, 60 months

Sponsors and collaborators

Lead sponsor

University of Ulm

Other

Collaborators

  • B. Braun Melsungen AG
  • OrbusNeich

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2014
First posted
Aug 12, 2008
Registry last updated
Jun 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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