NCT00732953

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_2 coronary-artery-disease

Timeline
Completed

Started Feb 2009

Longer than P75 for phase_2 coronary-artery-disease

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 7, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 12, 2008

Completed
6 months until next milestone

Study Start

First participant enrolled

February 1, 2009

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
4.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

June 10, 2014

Status Verified

June 1, 2014

Enrollment Period

11 months

First QC Date

August 7, 2008

Last Update Submit

June 7, 2014

Conditions

Coronary Artery Disease

Keywords

patients with coronary artery diseasepercutaneous coronary interventionstent implantationpaclitaxel eluting balloonangiographic follow-upclinical follow-up

Outcome Measures

Primary Outcomes (1)

  • Late loss

    6 months

Secondary Outcomes (7)

  • Diameter stenosis

    6 months

  • Binary restenosis rate

    6 month

  • Late loss index

    6 months

  • Target lesion revascularization

    2, 6, 12, 24, 36, 48, 60 months

  • Target vessel revascularization

    2, 6, 12, 24, 36, 48, 60 months

  • +2 more secondary outcomes

Study Arms (2)

1

ACTIVE COMPARATOR

Genous stent implantation with paclitaxel-eluting balloon therapy

Device: Genous stent implantation with paclitaxel-eluting balloon dilation

2

ACTIVE COMPARATOR

Genous stent implantation

Device: Genous stent implantation

Interventions

Genous stent implantation with paclitaxel-eluting balloon dilationDEVICE

Genous stent implantation with paclitaxel-eluting balloon therapy

1
Genous stent implantationDEVICE

Genous stent implantation

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Klinikum Coburg

Coburg, 96450, Germany

Location

University of Ulm

Ulm, 89081, Germany

Location

Schwarzwald-Baar Klinikum

Villingen-Schwenningen, 78011, Germany

Location

Related Publications (2)

  • Wohrle J, Birkemeyer R, Markovic S, Nguyen TV, Sinha A, Miljak T, Spiess J, Rottbauer W, Rittger H. Prospective randomised trial evaluating a paclitaxel-coated balloon in patients treated with endothelial progenitor cell capturing stents for de novo coronary artery disease. Heart. 2011 Aug;97(16):1338-42. doi: 10.1136/hrt.2011.226563. Epub 2011 May 26.

    PMID: 21617163BACKGROUND

  • Seeger J, Markovic S, Birkemeyer R, Rittger H, Jung W, Brachmann J, Rottbauer W, Wohrle J. Paclitaxel-coated balloon plus bare-metal stent for de-novo coronary artery disease: final 5-year results of a randomized prospective multicenter trial. Coron Artery Dis. 2016 Mar;27(2):84-8. doi: 10.1097/MCA.0000000000000314.

    PMID: 26479969DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Jochen Wöhrle, MD

    University of Ulm

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. Jochen Wöhrle

Study Record Dates

First Submitted

August 7, 2008

First Posted

August 12, 2008

Study Start

February 1, 2009

Primary Completion

January 1, 2010

Study Completion

February 1, 2014

Last Updated

June 10, 2014

Record last verified: 2014-06

Locations

DE(3)